Article Archives

• New Lynx® CDR Connector Sizes Bring Increased Flexibility to Your Process

  Issue: February 17, 2017
  Categories: Downstream, Upstream
  
  
  Now with a full range of sizes, the Lynx® CDR connector is available for use with multiple tube sizes.
  Read more »

• Blood Plasma Website Gets Ultimate Makeover to Help Optimize Your Process

  Issue: February 17, 2017
  Category: Downstream, Formulation, Regulatory Topics, Upstream, Merck Topics
  
  
  We’ve re-designed our blood plasma website to function as your gateway to critical blood plasma fractionation resources.
  Read more »

• Webinar Presents How to Reduce Risk of mAb Aggregation in Bioprocessing

  Issue: February 17, 2017
  Categories: Downstream, Formulation, Merck Topics, Regulatory Topics, Upstream
  
  
  Our webinar will explore how and why biological product aggregates form within a bioprocessing environment.
  Read more »

• Winners of Emerging Biotech Grant Program Announced

  Issue: February 17, 2017
  Category: Merck Topics
  
  
  We are excited to announce the winners of our 2016 Emerging Biotech Grant Program in Europe.
  Read more »

• Webinar Explores Overcoming Regulatory Challenges of Implementing Single-Use Technologies

  Issue: January 25, 2017
  Categories: Upstream, Downstream, Regulatory
  
  
  Our webinar, “Overcoming Quality and Regulatory Challenges of Implementing Single-use Pharmaceutical Manufacturing,” will provide insight into industry and regulatory requirements for single-use pharmaceutical manufacturing systems.
  Read more »

• Winner Chosen for 2016 Life Science Award in Bioseparations

  Issue: January 25, 2017
  Category: Merck Topics
  
  
  On October 18, Ying Li, from The Pennsylvania State University, was selected as the winner of the EMD Millipore 2016 Life Science Award in Bioseparations.
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• High Performance Meets Ease of Use with Mobius® Power MIX Systems

  Issue: January 25, 2017
  Categories: Upstream
  
  
  The Mobius® Power MIX family of single-use mixing systems are engineered with advanced high performance technology to easily handle difficult-to-mix buffers, cell culture media powders and other pharmaceutical ingredients.
  Read more »

• Creating Greater Access to More Affordable Vaccines Through Process Efficiency and Innovation

  Issue: January 25, 2017
  Category: Upstream, Downstream, Formulation
  
  
  Vaccines have the power to protect against disease and offer a better quality life. In many regions of the world, however, access to high quality vaccines at an affordable price is difficult.
  Read more »

• New Video Series on Managing Aggregates

  Issue: December 22, 2016
  Categories: Merck Topics, Downstream, Formulation, Upstream, Regulatory Topics
  
  
  In this new video series, our experts discuss which steps in the biomanufacturing process are involved in the formation or removal of aggregates and their recommended solutions.
  Read more »

• Webinar Presents Strategies for Mitigating Risk in Emerging Markets

  Issue: December 22, 2016
  Category: Regulatory Topics
  
  
  In early October, we presented a webinar, “Strategies for Mitigating Risk When Entering Emerging Markets,” in which we take a look at the changing biopharma landscape as well as strategies for scaling your process.
  Read more »

• Build and Customize Upstream and Downstream Suites with New App

  Issue: December 22, 2016
  Categories: Downstream, Formulation, Upstream, Merck topics
  
  
  This new app depicts a scalable biopharmaceutical process workflow for mAb and ADC manufacturing from research to commercial production.
  Read more »

• Introducing Mobius® Power MIX 2000 for Difficult-to-Mix Biopharm Ingredients

  Issue: December 22, 2016
  Category: Upstream
  
  
  The Mobius® Power MIX 2000 single-use mixing system is the latest addition to the Mobius® portfolio of single-use technologies for biomanufacturing.
  Read more »

• Merck Honored with CPhI Excellence in Pharma Awards

  Issue: November 29, 2016
  Categories: Formulation, Regulatory topics, Merck topics
  
  
  CPhI Pharma Awards recently honored Merck for groundbreaking innovations in technology, formulation, regulatory procedures and product development.
  Read more »

• New Parteck® MXP Excipient for Enhanced Solubility and Stable High Drug Loads

  Issue: November 29, 2016
  Categories: Bioavailability enhancement; Formulation
  
  
  We’ve launched Parteck® Melt Extrusion PVA (MXP), a new polyvinyl alcohol-based excipient which enhances solubility of a wide range of poorly bioavailable APIs.
  Read more »

• State-of-the-Art M Lab™ Collaboration Center Opens in South Korea

  Issue: November 29, 2016
  Category: Merck topics
  
  
  We are excited to announce the opening of our new M Lab™ Collaboration Center in the Songdo district of Incheon, South Korea, one of the fastest growing biotech hubs in Asia.
  Read more »

• Calculations Made Easy with our Chromatography Volume & Flow Rate Tool

  Issue: October 26, 2016
  Categories: Downstream
  
  
  Scientists and engineers working on preparative chromatography routinely have to make calculations for column packing, process development, and scale up.
  Read more »

• Tentacle Ion Exchange Chromatography Animation: How It Works

  Issue: October 26, 2016
  Category: Downstream
  
  
  Purifying a protein can be a challenging task – that’s why it is critical to choose the right chromatographic media and conditions.
  Read more »

• Bioprocessing Technology Trends of RNA-Based Therapeutics and Vaccines

  Issue: October 26, 2016
  Category: Downstream, Upstream
  
  
  In a recently published article, an overview of the types of RNA-based therapeutics in existence and their optimal methods of manufacture, purification, formulation and delivery are presented.
  Read more »

• New Presentation Highlights How to Make Novel Therapies a Reality

  Issue: September 27, 2016
  Categories: Downstream, Regulatory topics, Upstream
  
  
  A survey conducted by the Economist Intelligence Unit recently highlighted new products that the biopharma industry has identified as most disruptive to their growth strategies in the next five years.
  Read more »

• Viresolve® Pro Shield H Combined with Viresolve® Pro Device Delivers High Parvovirus LRV, Capacity and Flux

  Issue: September 27, 2016
  Category: Downstream
  
  
  We are pleased to announce the newest member of the Viresolve® Pro Solution family – Viresolve® Pro Shield H, a membrane-based adsorptive prefilter that is used in conjunction with the Viresolve® Pro Device, providing you with unmatched viral clearance.
  Read more »

• MVM Resistance Through Genetic Engineering

  Issue: September 27, 2016
  Category: Upstream
  
  
  Our unwavering commitment to be on the leading edge of risk mitigation strategies against adventitious agent contaminations has led us to a completely new approach to viral safety.
  Read more »

• Overcoming Challenges of High Pressure Operations with SUS

  Issue: September 27, 2016
  Category: Upstream
  
  
  In a recent article, the pressure rating of the key available components in single-use assemblies were summarized and then compared independently as well as when joined together.
  Read more »

• Excipients Portfolio Now Includes Polymers for Sustained Release Injectables

  Issue: August 24, 2016
  Category: Formulations
  
  
  Our excipients portfolio has expanded to now include 38 polymers for sustained release of small molecule and selected peptide injectables, allowing customers to optimize and precisely control release kinetics of final drug products.
  Read more »

• Explore, Learn and Collaborate at Our M Lab™ Collaboration Centers

  Issue: August 24, 2016
  Category: Merck Topics
  
  
  Step into an M Lab™ Collaboration Center – and get a whole new perspective on your biomanufacturing challenges.
  Read more »

• Empowering Biotech Startups to Solve Their Toughest Challenges

  Issue: August 24, 2016
  Category: Merck Topics
  
  
  As part of our commitment to meet the needs of the life science community, we’ve developed several grant programs that recognize stand-out emerging biotech (EB) companies.
  Read more »

• Emprove® Program Expands to Include Filtration and Single-Use Products

  Issue: July 26, 2016
  Category: Regulatory Topic
  
  
  We are pleased to announce that our industry-leading Emprove® program has expanded to include a selection of products for filtration and single-use processing.
  Read more »

• Size-Exclusion Chromatography for Preparative Purification of Biomolecules

  Issue: July 26, 2016
  Category: Downstream
  
  
  In a recent article, application data to support the use of SEC beyond small-scale operations, using Fractogel® EMD BioSEC (S) resin was presented.
  Read more »

• New High-Area Scaling Vodcast Series Now Available

  Issue: July 26, 2016
  Category: Downstream
  
  
  Recently, we developed a vodcast series that explores points to consider for reliable scale up of your filtration application, particularly using high area filters.
  Read more »

• New Study Highlights Biopharma’s Current and Future Growth Drivers

  Issue: July 26, 2016
  Category: Merck Topics
  
  
  We recently sponsored a study that was conducted by the Economist Intelligence Unit (EIU), in which 254 global biopharmaceutical executives were asked how their companies will manage new risks associated with the changing biopharma landscape.
  Read more »

• Speeding Biosimilar Development Using Glycosylation Control Technology

  Issue: June 22, 2016
  Category: Upstream
  
  
  With strong growth in the biosimilars market competition is rife, as numerous companies fight to get their drug to market first and win market share.
  Read more »

• Connect, Disconnect and Reconnect with New Lynx® CDR Sterile Connectors

  Issue: June 22, 2016
  Category: Downstream, Upstream
  
  
  We recently launched the Lynx® CDR Connector, providing users the ability to connect, disconnect and reconnect their single-use and hybrid systems, from upstream through downstream.
  Read more »

• Webinar: Combined Dual pH/Salt Gradients for the Separation of Challenging Protein Variants

  Issue: June 22, 2016
  Category: Downstream
  
  
  Ion-exchange chromatography typically uses gradients of increasing salt concentration at a constant pH-value for elution; a technical approach that has been used at process scale in the biopharmaceutical industry for decades.
  Read more »

• Best Practices for Critical Sterile Filter Operations

  Issue: June 22, 2016
  Category: Downstream
  
  
  In today’s biopharmaceutical industry, pre-use post-sterilization integrity testing (PUPSIT) is a widely used practice that detects damage that may have occurred during installation and sterilization.
  Read more »

• New Mobius® 1000 L Single-Use Bioreactor Brings Ease of Use to Single-Use

  Issue: May 24, 2016
  Category: Downstream
  
  
  The new Mobius® 1000 L single-use bioreactor completes the comprehensive Mobius® stirred tank portfolio of 3 to 2000 L sizes, delivering greater flexibility and continuity for scale-up and reducing the need for re-training of operators during scale-up.
  Read more »

• Webinar: Flow Through Chromatography and Adsorptive Depth Filtration for Continuous Processing

  Issue: April 26, 2016
  Category: Downstream
  
  
  Chromatography steps such as binding and elution can be challenging to implement in continuous processing. With step-wise load/wash/elute/clean cycles used, multiple columns are required to provide a continuous elution stream.
  Read more »

• Paper Discusses How to Optimize Media Feeding Strategies

  Issue: May 24, 2016
  Category: Upstream
  
  
  Performance improvements of upstream mammalian bioprocesses can be accomplished through manipulation of cell line characteristics, adjustment of media and feed formulations, as well as optimization of process parameters.
  Read more »

• High Throughput Screening of Resin Cleaning Procedures

  Issue: April 26, 2016
  Category: Downstream
  
  
  A recently published article describes the use of high throughput (HT) tools to assess cleaning agents for a mAb polishing step utilizing Fractogel® EMD TMAE HiCap (M) anion exchange (AEX) resin.
  Read more »

• Webinar: High Viscosity UF Formulation for Plasma IgG and mAbs

  Issue: April 26, 2016
  Category: Downstream
  
  
  Ease of administration and high dose applications are driving the bioprocessing industry to formulate higher concentration biotherapeutics.
  Read more »

• Chromatography User Group Meeting a Continued Success

  Issue: April 26, 2016
  Category: Downstream
  
  
  Our chromatography user group meeting recently took place in San Francisco, California on February 23-25, 2016.
  Read more »

• Vodcast Series Highlights Final Fill Process Design Considerations

  Issue: January 26, 2016
  Category: Merck topics
  
  
  Final fill applications present complex challenges in a process where risks are high and every drop of the product is valuable. The many concerns at final fill include patient safety, product yield, and regulatory compliance.
  Read more »

• Webinar: Recent Developments in Oral Sustained Release Formulations

  Issue: January 26, 2016
  Category: Merck topics
  
  
  Modified release formulations offer numerous opportunities, including the possibility to improve the therapeutic efficacy of a drug. Out of the numerous approaches for modified release, each has its own benefits and drawbacks, as there is no one-size-fits-all solution for modified release formulations.
  Read more »

• Millipore Express® High Area Cartridges for Improved Efficiency

  Issue: January 26, 2016
  Category: Downstream
  
  
  We recently launched the Millipore Express® Sterile High Capacity (SHC) and Sterile High Retention with onboard Pre-filter (SHR+P) high area cartridges for increased productivity and process efficiency. The innovative design of these new membrane filters provides greater filtration capacity in a smaller footprint, improving filtration economics for biopharmaceutical manufacturing.
  Read more »

• EDQM Grants New CEPs for Three Life Science API Products

  Issue: January 26, 2016
  Category: Merck topics
  
  
  The “Certificate of Suitability to the monograph of the European Pharmacopoeia” (CEP) is granted upon demonstration that the quality of a substance is suitably controlled by the relevant monograph of the European Pharmacopoeia.
  Read more »

• Clarification Solution for High-Density Cell Culture Harvests

  Issue: January 26, 2016
  Category: Merck topics
  
  
  Clarification of harvested cell culture broth is crucial for the efficient reuse of Protein A columns in the purification of antibodies as the plugging components, such as cells and colloids, are removed. With recent advances in mammalian expression systems, the separation process has posed challenges due to the high proportion of solids and colloids.
  Read more »

• New Webinar: How Excipient Suppliers Can Support QbD

  Issue: January 26, 2016
  Category: Downstream
  
  
  Pharmaceutical manufacturers are under increased pressure from health authorities worldwide to implement Quality by Design (QbD) principles for novel and generic drugs. By utilizing this approach, it provides increased control over product quality and excipient supply.
  Read more »

• Updated Sterile Filtration Selection Guide Simplifies Process

  Issue: January 26, 2016
  Category: Regulatory topics, Merck topics
  
  
  We are pleased to announce that advanced features have been added to our Sterile Filtration Product Selection Guide, making it even easier for you to find the right sterile filter for your application and process requirements.
  Read more »

• New Webinar Highlights Benefits of Single-Pass TFF

  Issue: January 26, 2016
  Category: Regulatory topics, Merck topics
  
  
  Continuous bioprocessing is generating considerable excitement in the biopharma industry as it promises to increase efficiency, decrease equipment footprint, reduce underused plant capacity and, ultimately, lower cost of goods.
  Read more »

• Introducing Our New Brand

  Issue: January 26, 2016
  Category: Merck topics
  
  
  We are excited to announce that we launched our new brand identity. Our updated visual image is designed to represent a vibrant science and technology company, and is inspired by the colorful and multifaceted shapes seen under a microscope.
  Read more »

• Updated Biopharmaceutical Application Guide: Find the Products and Services You Need for Your Process

  Issue: January 26, 2016
  Category: Merck topics
  
  
  We are pleased to announce that our interactive Biopharmaceutical Application Guide now features three new markets – Plasma Factor VIII, Viral Vector Vaccines, and Virus-Like Particle Vaccines.
  Read more »

• Save Time and Reduce Costs with Chromabolt® Prepacked Chromatography Columns

  Issue: January 26, 2016
  Category: Downstream
  
  
  Prepacked chromatography columns are on the rise in today’s biopharmaceutical industry. With the ability to increase plant flexibility and efficacy, drug manufacturers are utilizing these columns to get to market faster.
  Read more »

• New White Paper Discusses How Suppliers Can Create a Safer Production Environment

  Issue: January 26, 2016
  Category: Regulatory topics, Merck topics
  
  
  Proper handling of commonly used chemicals in bioprocessing is critical to maintaining a safe working environment as well as operational efficiency. As new technologies designed to help mitigate these safety risks become available, biomanufacturers have more opportunities to ensure their production environments are safe.
  Read more »

• Single-use final fill interactive guide now available

  Issue: September 29, 2015
  Category: Upstream
  
  
  Traditional formulation and final fill operations have productivity challenges that can limit process flexibility. With the number of clinical runs increasing and new drugs having smaller lot sizes and highly potent ingredients, manufacturers need to incorporate single-use technologies to respond to these demands.
  Read more »

• Provantage® Tech Transfer Services: Your process train, where and when you need it

  Issue: September 29, 2015
  Category: Upstream
  
  
  Are you looking to tech transfer your existing mAb production process into a new facility? With Provantage® End-to-End Services, we have the products, services and partnerships you need to be successful.
  Read more »

• Updated Drug Master Files for filtration devices now available

  Issue: September 29, 2015
  Category: Upstream, Downstream
  
  
  We are pleased to announce that we have updated and revised the United States Drug Master Files (DMFs) for our Durapore®, Millipore Express®, Viresolve® and Viresolve® NFR Filters with Retropore® membrane filtration devices.
  Read more »

• Webinar: Process of the future: Cheaper, faster and safer

  Issue: September 29, 2015
  Category: Upstream, Downstream
  
  
  Despite the introduction of new technologies, biotech processes still contain a number of open and at-risk transfer steps. Cell culture transfer from one vial to containers such as T-flasks or shake flasks, and then to the bioreactor, is usually one of these open at-risk phases.
  Read more »

• You're invited: Merck's 2016 Chromatography User Group Meeting

  Issue: September 29, 2015
  Category: Upstream
  
  
  We are excited to announce that our Annual Chromatography User Group Meeting dates have been released! Please join us at the Hyatt Fisherman's Wharf in San Francisco, California on February 23-25, 2016.
  Read more »

• Webinar: Novel synthetic adsorptive depth filter media for CHO-S harvest clarification

  Issue: September 29, 2015
  Category: Upstream
  
  
  Recent advancements in the productivity of upstream cell culture processes for the manufacture of therapeutic proteins has resulted in greatly increased cell densities and higher levels of process-related impurities.
  Read more »

• Customer seminar highlights innovative strategies in upstream processing

  Issue: September 29, 2015
  Category: Upstream, Downstream
  
  
  Recently, Merck successfully held its 2nd upstream seminar: "Bioproduction with confidence," in Darmstadt, Germany.
  Read more »

• Poster: Production and purification of a VLP-based Hepatitis C vaccine candidate

  Issue: September 29, 2015
  Category: Upstream, Downstream
  
  
  Virus-like particles (VLPs) have been proven to be a good vaccine technology platform due to safety and immunogenicity factors.
  Read more »

• New video: final filtration made simple

  Issue: September 29, 2015
  Category: Upstream
  
  
  Final filling can be a complex and challenging unit operation for drug manufacturers. Product purity, yield, sterility assurance, and regulatory compliance are just some of the concerns at this step.
  Read more »

• New Parteck® SRP 80 excipient - take control of drug release

  Issue: September 29, 2015
  Category: Upstream
  
  
  Merck is excited to announce the newest addition to its Parteck® functional excipients portfolio, Parteck® SRP 80. This new excipient has been designed for more reliability and consistency in sustained-release solid dose formulations.
  Read more »

• Benefits of cell culture based influenza vaccine inherent to processing

  Issue: September 29, 2015
  Category: Upstream, Downstream
  
  
  Each year vaccine manufacturers are faced with challenges as they develop and produce the seasonal influenza vaccine.
  Read more »

• Formalized risk assessment: Challenges and best practices

  Issue: September 29, 2015
  Category: Upstream
  
  
  In recent years, risk assessment has become an integral step for drug manufacturers in identifyingsuitable materials and consumables for their manufacturing processes.
  Read more »

• Upstream services for fast-track manufacturing of proteins

  Issue: September 29, 2015
  Category: Upstream
  
  
  Biopharmaceutical developers are faced with increasing pressure to develop new drug products quickly and efficiently.
  Read more »

• Provantage® End-to-End services: Biodevelopment from molecule to production

  Issue: September 29, 2015
  Category: Upstream, Downstream
  
  
  Are you looking to expand the production of your recombinant proteins, vaccines or plasma commercial drugs? Do you need to bring affordable biosimilars to emerging markets?
  Read more »

• New Emprove® program to facilitate risk assessment

  Issue: September 29, 2015
  Category: Regulatory Topics
  
  
  Merck is excited to introduce new enhancements to our Emprove® program of pharmaceutical raw and starting materials.
  Read more »

• New white paper offers insights from Emerging Biotech Executive Summit

  Issue: September 29, 2015
  Category: Upstream, Downstream
  
  
  Taking a biotech molecule from discovery to commercialization continues to be complex and challenging.
  Read more »

• Industry best practices for TFF cassette reuse and storage

  Issue: August 24, 2015
  Category: Upstream, Downstream
  
  
  Tangential flow filtration (TFF) operations are an integral part of bioprocessing operations for clarification, concentration, diafiltration and formulation processes. If these processes occur immediately prior to final formulation
  Read more »

• Experience ACHEMA through our new product spotlight videos

  Issue: August 24, 2015
  Category: Upstream, Downstream
  
  
  As one of the largest life science industry tradeshows, held every three years in Frankfurt, Germany, ACHEMA is an event that connects over 170,000 attendees from more than 300 countries.
  Read more »

• Introducing our new LinkedIn® group: "Clarification Insights"

  Issue: August 24, 2015
  Category: Downstream
  
  
  The biopharmaceutical industry, particularly the area of clarification, is constantly evolving. As new and exciting advances emerge, it is imperative to have a platform where peers from around the world can engage with and learn from each other.
  Read more »

• Beyond binding capacity: Chromatography resin manufacturers must find balance

  Issue: August 24, 2015
  Category: Downstream
  
  
  For many years, large-scale chromatography resins have been sold with much emphasis on binding capacity. However, it is important for chromatography resins to demonstrate a balance between capacity and selectivity with productivity and quality.
  Read more »

• Introducing Provantage® Clone Generation Services

  Issue: July 30, 2015
  Category: Upstream, Downstream
  
  
  The production of recombinant proteins requires a high expressing and reliable cell line that is ready for GMP manufacturing. At Merck, we understand this is a critical component for the development and production of a biological drug.
  Read more »

• Introducing Mobius® 2000 L Single-use Bioreactor

  Issue: July 30, 2015
  Category: Upstream
  
  
  Merck is excited to announce the newest member of the Mobius® bioreactor family – the Mobius® 2000 L single-use bioreactor; a scalable ergonomic system with the flexibility to fit your process.
  Read more »

• IEX Chromatography: Optimization strategies for higher purity

  Issue: July 30, 2015
  Category: Downstream
  
  
  During the downstream processing of monoclonal antibodies (mAbs), ion exchange chromatography (IEX) is a crucial purification tool. Within the two types of ion exchange chromatography - cation exchange (CEX) and anion exchange (AEX)
  Read more »

• Application of QbD Principles to Ultrafiltration Operations in Bioprocessing

  Issue: July 30, 2015
  Category: Downstream
  
  
  Today's biopharmaceutical industry is under pressure from regulatory organizations to meet increasing levels of compliance, and from pharmaceutical buying advocates and the financial community to show better operating economics.
  Read more »

• New GDP guidelines for APIs

  Issue: July 30, 2015
  Category: Regulatory Topics
  
  
  This past March, the EU commission published new guidelines on the principles of Good Distribution Practice (GDP) of active substances for medicinal products for human use.
  Read more »

• Challenges and promises of biosimilar upstream process development

  Issue: June 24, 2015
  Category: Upstream
  
  
  The need for affordable medications and the anticipation of blockbuster patent expirations have created great opportunities for biosimilars development.
  Read more »

• Characterization of postcapture impurity removal

  Issue: June 24, 2015
  Category: Upstream
  
  
  During the virus inactivation and subsequent pH adjustment steps of a MAb manufacturing process, operators commonly observe a significant amount of precipitation and turbidity in their product pools.
  Read more »

• Facilitating the IDL process with registered dossiers

  Issue: June 24, 2015
  Category: Regulatory Topics
  
  
  When manufacturing or selling drugs in China, Imported Drug Licenses (IDLs) are mandatory for imported drugs, APIs and pharmaceutical excipients.
  Read more »

• Webinar: Solvent detergent viral inactivation

  Issue: June 24, 2015
  Category: Downstream
  
  
  Biomanufacturing plasma-derived products requires at least two orthogonal virus reduction steps to comply with regulatory pathogen safety risk mitigation guidelines.
  Read more »

• Production and purification of virus-like particles

  Issue: May 21, 2015
  Category: Downstream
  
  
  Virus-like particles (VLPs) represent an appealing model for vaccine development, as they resemble native viruses but are not infectious.
  Read more »

• Introducing Cellvento™ CHO media platform for top performance in cell culture

  Issue: May 21, 2015
  Category: Upstream
  
  
  Selecting the right medium to optimally match your cell line is a challenging task. Results have to be scalable, reproducible in every run and antibody quality attributes need to be consistent.
  Read more »

• Protect your buffer process with new Millipore Express® PHF filters

  Issue: May 21, 2015
  Category: Downstream, Upstream
  
  
  The Millipore Express® PHF hydrophilic filter is the newest member of the Millipore® Express family of sterilizing grade filters. Designed for buffer process protection, it provides broad chemical compatibility, high flow rates
  Read more »

• Dossier for New Chemical Entity approval

  Issue: May 21, 2015
  Category: API, Regulatory Topics
  
  
  At Merck, we continuously strive to bring our regulatory expertise to the next level in order to better help you with your approval processes. One example of this is our regulatory documentation for active pharmaceutical ingredients.
  Read more »

• Compacted Media: A new level of convenience in handling dry powder media

  Issue: May 21, 2015
  Category: Upstream
  
  
  Handling dry powder media can be challenging. To provide you with a new level of convenience, we have compacted the powder into granules. The resulting compacted media significantly minimize dust formation, improving media handling.
  Read more »

• Strategies for Fab purification and formulation

  Issue: April 28, 2015
  Category: Formulation, Downstream
  
  
  Monoclonal antibodies (mAbs) continue to be an important class of therapeutics for the biotechnology industry. In recent years, however, increased attention has been devoted to the development of "next generation" biologic therapeutics.
  Read more »

• Chromabolt® prepacked columns with new resins increase productivity

  Issue: April 28, 2015
  Category: Downstream
  
  
  We are pleased to announce that two additional chromatography resins, Fractogel® TMAE and Fractogel® DEAE are available in Chromabolt® prepacked columns for pilot and early clinical manufacturing.
  Read more »

• Demystifying bioreactor contamination risks

  strong>Issue:April 28, 2015
  Category: Upstream
  
  
  The mitigation of bioreactor contamination risk is complex. Manufacturers can be lulled into a false sense of security, trusting that serum-free media eliminates such risks. However, the presence of contaminants such as mycoplasma can still exist.
  Read more »

• Merck announces winner of 2014 Emerging Biotech Grant Program

  Issue: March 24, 2015
  Category: Upstream, Downstream
  
  
  Committed to helping advance lifesaving drugs to market, Merck hosted its first emerging biotech grant program last year, awarding one company up to $89,000 in products and services to help develop their molecule.
  Read more »

• Updated Sterile Filtration Product Selection Guide now available

  Issue: March 24, 2015
  Category: Upstream, Downstream
  
  
  We are pleased to announce that advanced features have been added to our Sterile Filtration Product Selection Guide, making it even easier for you to find the right filter and services based on your application and process requirements.
  Read more »

• New! Formulation Product Finder App

  Issue: March 24, 2015
  Category: Formulation, API, Bioavailability
  
  
  Having trouble finding the right product for your formulation? Quickly find a solution with our new Formulation Product Finder App for tablets.
  Read more »

• An efficient way to increase capacity, recovery and concentration

  Issue: March 24, 2015
  Category: Upstream, Downstream
  
  
  Merck is pleased to introduce Single-Pass TFF with Pellicon® cassettes, an enhanced application of our existing TFF technology that allows you to concentrate process streams without the recirculation required in traditional TFF steps.
  Read more »

• Production and purification of plasmid DNA vaccines

  Issue: February 26, 2015
  Category: Upstream, Downstream
  
  
  The demand for plasmid DNA (pDNA) has vastly increased over the past decade in response to significant advances that have been made in its application for gene therapy and vaccine development.
  Read more »

• New Guideline on Elemental Impurities and its implications

  Issue: February 26, 2015
  Category: Regulatory Topics, Formulation
  
  
  The ICH recently published the guideline ICH Q3D to control elemental impurities, which will have a huge impact on the control strategy of metal and other inorganic impurities for drug products worldwide. The EMA announced that the new requirements
  Read more »

• Impact of process loading on TFF microfiltration

  Issue: February 26, 2015
  Category: Upstream, Downstream
  
  
  Tangential flow filtration (TFF) microfiltration is one of the choices for clarification of mammalian cell or microbial cell culture in the biopharmaceutical industry. Unlike ultrafiltration, TFF microfiltration is limited by a maximum throughput
  Read more »

• Newly expanded Interactive Application Guide available

  Issue: January 28, 2015
  Category: Upstream, Downstream, Formulation
  
  
  Our Biopharmaceutical Application Guide, an online tool that helps you find the right Merck solution for your process needs, is now even more comprehensive.
  Read more »

• Examining single-use MIX vessels with protein solutions

  Issue: January 28, 2015
  Category: Upstream
  
  
  The increasing implementation of single-use equipment and assemblies in biopharmaceutical processes has resulted in more flexible facilities with faster batch-to-batch and product-to-product turnaround times.
  Read more »

• GDP for APIs: Support from APIC "How to" document

  Issue: January 28, 2015
  Category: Regulatory Topics
  
  
  Until recently, specific regulations on Good Distribution Practices (GDP) for distributors of APIs were not required. However, with the EU Falsified Medicines Directive (Directive 2011/62/EU) the application of GDP for APIs is now becoming mandatory.
  Read more »

• Save time using our sizing tool for buffer filtration

  Issue: December 17, 2014
  Category: Downstream, Upstream
  
  
  Buffer solutions are a key requirement in various process steps of pharmaceutical and biotechnology therapeutics including: cell culture media, chromatography, ultrafiltration, diafiltration, and final formulation.
  Read more »

• New webinar highlights how to cope with challenges of quality agreements

  Issue: December 17, 2014
  Category: Regulatory Topics
  
  
  Negotiating a quality agreement is time-consuming. Our recent webinar, "Quality agreements for pharmaceutical raw materials," was created to help inform you of the considerations you need to take into account for pharma raw materials.
  Read more »

• New application data for PVA portfolio increases efficiency

  Issue: December 17, 2014
  Category: Bioavailability, Formulation
  
  
  In order to provide the best support for your formulation processes, and help you save time and make your work more efficient, we have collected new application data for our PVA portfolio, including dissolution rate.
  Read more »

• Webinar: Best practices for PD using small-scale Millistak+® filters

  Issue: November 26, 2014
  Category: Upstream, Downstream
  
  
  Clarification of mammalian cell culture harvest remains an important step in biotherapeutic production. With advancements in capacity of depth-filtration media and the move towards single-use, clarification via two-step depth filtration.
  Read more »

• Upcoming webinar to discuss PureFlex™ Plus single-use film

  Issue: November 26, 2014
  Category: Downstream
  
  
  Biopharmaceutical companies are using single-use containers and assemblies for upstream and downstream processes at an ever increasing rate. Today's films must meet the demands of new applications, especially the requirements of high volume.
  Read more »

• Introducing the new NovaSeptum® single-use holder

  Issue: November 26, 2014
  Category: Downstream
  
  
  Sampling your product is critical throughout the manufacturing process to ensure quality and compliance with regulations. Improper sampling can lead to quarantine, repeat of analysis and sometimes in worse case scenarios, deviation or loss.
  Read more »

• Highlights of latest revision of EU GMP Guidelines

  Issue: November 26, 2014
  Category: Regulatory Topics
  
  
  In August 2014, the EU commission published revisions to Chapter 3 "Premises and Equipment" and Chapter 5 "Production" of the EU GMP guideline, that will take effect on March 1, 2015.
  Read more »

• In the media: clarification article in BPI

  Issue: October 28, 2014
  Category: Downstream
  
  
  We are pleased to announce that in the current issue of Bioprocess International (BPI) a paper authored by Sarah Le Merdy, a Field Marketing Specialist at Merck, is published.
  Read more »

• Compacted cell culture media: Improving stability and solubility

  Issue: October 28, 2014
  Category: Upstream
  
  
  We invite you to join us on November 13, as we present the webinar, "Compacted cell culture media: Improving the homogeneity, stability, solubility and convenience of dry powder cell culture media."
  Read more »

• Celebrating 10 years of EMPROVE® qualification

  Issue: October 28, 2014
  Category: Regulatory Topics
  
  
  In 2004, Merck anticipated the upcoming trend of stricter regulations for excipients that would require drug manufacturers to create more efficient documentation for pharmaceutical products. For this reason, we defined a standard method.
  Read more »

• Leachables case study: Adopting single-use to improve speed to clinic

  Issue: September 25, 2014
  Category:
  
  
  As the opportunity to use single-use technologies throughout the clinical/manufacturing pipeline expands, there is a heightened risk of leachables being present in the drug substance. This leads to an increased incentive to evaluate, understand.
  Read more »

• Don't miss our 2014 Chromatography User Group Meetings

  Issue: September 25, 2014
  Category: Downstream
  
  
  Merck's Annual Chromatography User Group Meetings are right around the corner. Join us in Tiburon, CA with your chromatography peers to share best practices, exchange common industry observations and identify existing challenges.
  Read more »

• Cellvento™ CHO cell culture medium portfolio expands

  Issue: September 25, 2014
  Category: Upstream
  
  
  With Cellvento™ CHO cell culture media, you have come to rely on superior chemically defined, non-animal origin media formulations for batch and fed-batch mode operations. Now, Merck is excited to announce that we have expanded our portfolio.
  Read more »

• Webinar: Reducing costs in solid dose formulations

  Issue: July 23, 2014
  Category: Bioavailability, Formulation
  
  
  Formulation is no easy task. With budgets being a constant concern, manufacturers are forced to decrease costs throughout their process. However, choosing the cheapest excipient may not be the best solution when considering the overall cost.
  Read more »

• New chromatography resins available in Chromabolt® pre-packed columns

  Issue: July 23, 2014
  Category: Downstream
  
  
  Chromatography columns are evolving. Within the biopharmaceutical industry, pre-packed columns are becoming a more attractive option, providing significant time savings and facility flexibility. Extensively validated pre-packed columns.
  Read more »

• New global website, new experience

  Issue: July 23, 2014
  Category: Merck Topics
  
  
  We are pleased to announce the launch of our new website – We listened to your feedback and have developed an improved user experience, with even better ways to access information.
  Read more »

• Interactive Biopharmaceutical Application Guide now available

  Issue: July 23, 2014
  Category: Merck Topics, Upstream, Downstream, Formulation
  
  
  We are pleased to announce the launch of our new Biopharmaceutical Application Guide, an online, interactive tool aimed at helping our customers find the right Merck solution for their process needs.
  Read more »

• Webinar series: Final filling process design considerations

  Issue: June 24, 2014
  Category: Downstream
  
  
  The final filling operation for any drug product is one of the most critical steps in your manufacturing process. One wrong move can not only impact patient safety, but also your revenue. Implementing single-use technologies is one way companies are.
  Read more »

• New webinar on impact of FDASIA for API and excipient suppliers

  Issue: June 24, 2014
  Category: Regulatory Topics
  
  
  The Food and Drug Administration Safety and Innovation Act, (FDASIA) was signed into law on July 9th 2012 and became effective on October 1st, 2012, strengthening the FDA's ability to safeguard and advance public health.
  Read more »

• Best practices: Nucleic acid removal from vaccine processes

  Issue: June 24, 2014
  Category: Upstream, Downstream
  
  
  The production of viral vaccines at commercial scale requires large quantities of viruses as an antigenic source. Because host cell residuals can be found in the final product, nucleic acids in particular, there is the chance of transfer.
  Read more »

• We did it again: FDA audit successfully passed

  Issue: May 20, 2014
  Category: API, Regulatory Topics
  
  
  In February 2014, the U.S. Food and Drug Administration (FDA) once again inspected Merck's active pharmaceutical ingredients (APIs) at their Darmstadt, Gernsheim and Schaffhausen sites. All were found without any observation (no form 483).
  Read more »

• Innovative batch traceability with new online tool

  Issue: May 20, 2014
  Category: Formulation, API, Regulatory Topics
  
  
  Supply chain transparency is essential in today's pharmaceutical market. Recognizing that the origin of a product is critical for our customers, Merck has launched eOMT, an electronic Original Manufacturer Tracking tool. eOMT fulfills the USP.
  Read more »

• Conquer high concentration challenges: new Pellicon™ 3 cassettes with D screen

  Issue: May 20, 2014
  Category: Downstream
  
  
  The need to process high concentration liquid formulations is driven by the desire to create injectable therapies. Traditionally many of these therapies were administered by infusion. For patients, injection means ease of administration.
  Read more »

• Merck expands portfolio of high-purity biological buffers

  Issue: April 16, 2014
  Category: Downstream
  
  
  With the introduction of MES, HEPES Na, MOPS and MES Na, Merck has expanded its portfolio of biological buffers, which have broad applications in large-scale biomanufacturing, predominantly in downstream processing.
  Read more »

• New FMDV LinkedIn® group connects industry experts

  Issue: April 16, 2014
  Category: Upstream
  
  
  Recently, Merck created a LinkedIn® group for the Foot and Mouth Disease vaccine (FMDV) community to enable experts to network and discuss challenges and trends in FMDV production.
  Read more »

• Interactive NovaSeptum® tool helps find the right configuration for your specific sampling challenge

  Issue: April 16, 2014
  Category: Downstream
  
  
  For many biopharmaceutical companies, closed single-use sampling offers countless benefits over traditional sampling methods including speed, risk mitigation and ease of operation.
  Read more »

• Biosimilars: The impact of variability in manufacturing

  Issue: April 16, 2014
  Category: Regulatory Topics
  
  
  Biotechnology products are highly complex and even slight changes, often resulting from modifications in how they are manufactured, can negatively affect their safety and efficacy profile.
  Read more »

• Supporting your process: risk assessment guidelines on excipients

  Issue: March 20, 2014
  Category: Regulatory Topics
  
  
  At Merck, we strive to stay up-to-date on the latest regulatory proceedings so we can fully support your process – keeping you informed about any changes you need to be aware of, as well as making sure these requirements are followed.
  Read more »

• Optimize your formulation with synthetic lipids

  Issue: March 20, 2014
  Category: Bioavailability
  
  
  Lipids can be difficult to utilize in your manufacturing process. Their waxy appearance can result in slow dissolution rates and challenges with handling larger lipid amounts. Lyophilization improves these properties but also increases the material's.
  Read more »

• New porous silica structure overcomes drug solubility challenges

  Issue: March 20, 2014
  Category: Bioavailability, Formulation
  
  
  With an increasing number of drug candidates failing in development, the pharmaceutical industry is facing a shortage of new drugs. Poor bioavailability causes over 40% of these failures, often due to low solubility.
  Read more »

• ChromaTALK™ moves to LinkedIn®

  Issue: March 20, 2014
  Category: Downstream
  
  
  There is no question that social media is changing the way we communicate with each other. For professionals, LinkedIn® is one of the most popular platforms today, allowing us to connect with colleagues, share information and stay up-to-date.
  Read more »

• Minimize caking of products with DRYPOUR™ packaging system

  Issue: February 18, 2014
  Category: Merck Topics
  
  
  For production without delays and optimum product quality, the right packaging of raw materials is essential. Hygroscopic salts in particular need protection against caking caused by moisture in their packaging.
  Read more »

• Cyclodextrin HPB: A path to better API solubility and stability

  Issue: February 18, 2014
  Category: Bioavailability, Formulation
  
  
  Merck's hydroxylpropyl-beta cyclodextrin is an ideal choice to effectively increase API solubility and stability. Due to its characteristics -- a molecule that resembles a hollow cone with a hydrophilic exterior and a more hydrophobic.
  Read more »

• New superdisintegrant for solid formulations

  Issue: February 18, 2014
  Category: Bioavailability, Formulation
  
  
  Merck's product family of excipients is growing. The new superdisintegrant, Parteck® CCS (Croscarmellose Sodium), expands our portfolio for solid formulation.
  Read more »

• CellPrime® r Insulin improves cell culture performance

  Issue: February 18, 2014
  Category: Upstream
  
  
  Insulin is a pivotal component in cellular carbohydrate metabolism, as it not only enhances cell growth but also protein production. Merck's CellPrime® r Insulin is your answer for improving the performance of your cell culture process.
  Read more »

• Solve process development challenges with Provantage® Services

  Issue: January 22, 2014
  Category: Upstream, Downstream
  
  
  As drug manufacturers, you not only need to ensure your drug development and production process is reliable, but you must also ensure the quality of your product while keeping your costs low.
  Read more »

• Protect your protein: TRIS high purity

  Issue: January 22, 2014
  Category: Downstream
  
  
  TRIS buffer systems are frequently used in the downstream purification of biomolecules - a process step where contamination with unknown impurities is highly unwanted.
  Read more »

• Final filling: process design considerations

  Issue: January 22, 2014
  Category: Downstream
  
  
  Final filtration and filling of your drug product is one of the most critical points in the manufacturing process. Product quality must be guaranteed to ensure patient safety. In addition, any filtration steps must be capable of satisfying system.
  Read more »

• Celebrating our 400th EMPROVE® product

  Issue: Issue: January 22, 2014
  Category: Formulation, Merck Topics
  
  
  Merck is pleased to welcome the 400th product to our EMPROVE® family. Pharmacopoeial potassium nitrate is now part of a portfolio of 400 active pharmaceutical ingredients, excipients and biopharmaceutical materials.
  Read more »

• Merck partners with Developing Countries Vaccine Manufacturers' Network to aid in vaccine education

  Issue: December 17, 2013
  Category: Upstream, Downstream
  
  
  As a leader in vaccine manufacturing processes, Merck is committed to lending a hand in making information quickly available to vaccine manufacturers in developing countries.
  Read more »

• Find the right sterile filter with our interactive app

  Issue: December 17, 2013
  Category: Downstream
  
  
  Sterile filtration is just one step in a complex process with many variables. To help you easily determine the right sterile filtration products you need, we have created a Sterile Selector Tool.
  Read more »

• Elemental impurities: Updates on USP, ICH and EMA guidelines

  Issue: December 17, 2013
  Category: Regulatory Topics
  
  
  The pharmaceutical industry is faced with an evolving number of guidelines that affect the control of elements -- primarily metals -- for drug products and ingredients such as APIs and excipients.
  Read more »

• Annual chromatography user group meetings provide forum for thought leadership

  Issue: December 17, 2013
  Category: Downstream
  
  
  Merck recently hosted its annual chromatography user group meetings in Washington, D.C. This event, which was broken into two meetings for Protein A affinity and ion exchange chromatography, enabled global end users to not only share.
  Read more »

• The conversion from stainless steel to single-use: what you need to know

  Issue: November 20, 2013
  Category: Downstream
  
  
  Traditional stainless steel equipment is increasingly being replaced with disposable technologies in both new and existing processes, allowing for more flexibility, higher efficiencies and lower costs.
  Read more »

• Optimize your cell growth with Fetal Bovine Serum (FBS)

  Issue: November 20, 2013
  Category: Upstream
  
  
  Despite the increasing shift towards using chemically defined media for cell culture, there are still many cell lines that require the use of serum-based media, making it imperative to have a high-quality Fetal Bovine Serum (FBS).
  Read more »

• New ready-to-use cleaning solution for chromatography resins

  Issue: November 20, 2013
  Category: Downstream
  
  
  Chromatography is a process step which is performed with high value resins that require sanitization between batches, as well as prior to storage. While NaOH, the most widely used sanitant in bioprocessing, is very effective for polymer based resins.
  Read more »

• New liquid media portfolio: flexibility at every scale

  Issue: November 20, 2013
  Category: Upstream
  
  
  More stringent safety regulations and the need for increased security in the biopharmaceutical industry have also led to enhanced safety standards for liquid media.
  Read more »

• Liquid-liquid porometry - measure PSD and predict LRV

  Issue: November 20, 2013
  Category: Downstream
  
  
  Virus removal, using membrane filtration based on size exclusion, is dictated by pore size distribution (PSD) of the membrane. However, information characterizing pore size distribution of virus filters, and comparisons of quantitative predictions.
  Read more »

• Parteck® SLC enhances drug bioavailability

  Issue: October 17, 2013
  Category: Formulation, Bioavailability
  
  
  The pharmaceutical industry is facing a shortage of new drugs -- existing patents are expiring and therapeutic pipelines are shrinking, as an increasing number of drug candidates fail in development. The cause for up to 40% of these failures is poor.
  Read more »

• Clarification made easy with pDADMAC flocculation reagent

  Issue: October 17, 2013
  Category: Downstream
  
  
  In today's biopharmaceutical industry, high-density cell culture processes pose a significant threat to clarification and purification operations. With high solid content and an increased number of submicron particles.
  Read more »

• Add safety to your process with our new encoded quick connector

  Issue: October 17, 2013
  Category: Downstream
  
  
  Discharging liquid chemicals from their packaging without compromising quality and purity during manufacturing can be a critical process step. Even more important is protecting employees.
  Read more »

• Solve your GMP production challenges with Provantage® Services

  Issue: October 17, 2013
  Category: Upstream, Downstream
  
  
  We understand that drug manufacturers face the major challenge of moving a molecule to clinic faster and more reliably. With more than 25 years of experience in the production and purification of recombinant proteins within mammalian cells.
  Read more »

• Introducing Clarisolve® depth filters for faster, more efficient primary clarification of pretreated feed streams

  Issue: September 26, 2013
  Category: Downstream
  
  
  The current evolution to high cell density and product titer cell cultures is placing a large burden on traditional downstream clarification and purification operations. To alleviate this bottleneck, various types of pretreatment options.
  Read more »

• Gain a competitive edge with Eshmuno® A chromatography media

  Issue: September 26, 2013
  Category: Downstream
  
  
  When it comes to chromatography, we understand the challenges of efficiently capturing your final product, while minimizing costs and speeding time to clinic. Product titers and impurities are steadily increasing, placing even greater demands on.
  Read more »

• Prepacked chromatography columns: the new trend in biopharmaceutical manufacturing

  Issue: September 26, 2013
  Category: Downstream
  
  
  In the interest of cutting costs, reducing production time and increasing plant flexibility, the biopharmaceutical industry has made a marked shift toward single-use manufacturing. One of the fastest growing segments of single-use technologies.
  Read more »

• Solve your processing challenges with Provantage® Services

  Issue: September 26, 2013
  Category: Upstream, Downstream
  
  
  The processing challenges you face throughout your manufacturing process demand a new approach. Whether it is accelerating time to market, product quality or improving productivity, there is a new way.
  Read more »

• The headquarter of Merck passes first EXCiPACT™ audit

  Issue: September 26, 2013
  Category: Regulatory Topics, Merck Topics
  
  
  Merck KGaA, Darmstadt, Germany, headquarter of Merck, has become one of the first companies to successfully complete a comprehensive EXCiPACT™ audit; a third-party certification for manufacturers, suppliers and distributors of pharmaceutical.
  Read more »

• Virus safety in upstream processing

  Issue: July 31, 2013
  Category: Upstream
  
  
  As part of a robust upstream process, many biotherapeutic manufacturers seek to execute a three-pronged virus safety strategy. This involves carefully sourcing raw materials, screening for adventitious viruses, and implementing process steps.
  Read more »

• TRIS and phosphate buffer test kits now available

  Issue: July 31, 2013
  Category: Downstream
  
  
  With the addition of three new products, our range of top-quality buffers is now wider than ever. TRIS-hydrochloride, TRIS high purity, and MES-Na are now available in EMPROVE® bio grade quality.
  Read more »

• Our NovaSeptum® single-use sterile sampling system

  Issue: July 31, 2013
  Category: Downstream
  
  
  When sampling your product to assure quality, it's vital to avoid both process and sample contamination. An inaccurate or false positive result can lead to quarantine – as well as the need to repeat the analysis.
  Read more »

• Our full-service liquid formulation offering

  Issue: July 31, 2013
  Issue: Formulation
  
  
  From buffers, solvents, and preservatives to stabilizers, thickeners, surfactants, and flavors, Merck has a wide portfolio of innovative raw materials for liquid dosage forms – including special excipients for ophthalmic and oral liquid.
  Read more »

• Our new Research & Development Center for Formulation

  Issue: July 31, 2013
  Category: Merck Topics
  
  
  Bioavailability enhancement is a key topic in the industry these days – and when our new Research & Development Center for Formulation (RDCF) opens in Q2 2013, we'll be ready to develop additional products that deliver.
  Read more »

• Our comprehensive stem cell production portfolio

  Issue: July 31, 2013
  Category: Upstream
  
  
  Stem cells have tremendous potential in the fields of clinical and drug, but to produce them successfully on an industrial scale, you need a partner who can supply exactly the right tools and production systems for your individual cell culture.
  Read more »

• New USP standards for elemental impurities

  Issue: July 31, 2013
  Category: Regulatory Topics
  
  
  Under the new USP standards, manufacturers will be required to prove that their finished drug products meet standards regarding elemental impurities. The stricter USP standards reflect a growing understanding of the toxicology of elemental.
  Read more »

• Mobius® FlexReady Solution with Smart Flexware® assemblies

  Issue: July 31, 2013
  Category: Downstream
  
  
  When therapeutic manufacturers purify their biopharmaceutical products, flexibility is key. In addition to high performance, our Mobius® FlexReady Solution with Smart Flexware® assemblies is designed to enable fast changes from chromatography to TFF.
  Read more »

• Cellvento™ CHO-200 medium for fed-batch mode

  Issue: July 31, 2013
  Category: Upstream
  
  
  Designed especially for fed-batch mode, our new CellventoTM CHO-200 medium, together with its complementary feeds, is the perfect match for CellventoTM CHO-100. Like its sister product, this chemically defined, non-animal origin medium is carefully.
  Read more »

• Eshmuno® CPX media for high-production downstream bioprocessing

  Issue: July 31, 2013
  Category: Downstream
  
  
  The key challenge during intermediate purification and polishing is the ability to remove impurities similar to the target molecule, even at high loading levels. With Eshmuno® CPX media, you can efficiently remove mAb dimers and higher molecular.
  Read more »

• E X-CYTE® growth enhancement media supplement

  Issue: July 31, 2013
  Category: Regulatory Topics
  
  
  When it comes to supplementation requirements and feeding strategies, mammalian cell lines are much more demanding than unicellular prokaryotes. For fine-tuning media composition and culture scale-up, it pays to work with an experienced partner.
  Read more »

• Comprehensive liquid media portfolio from Merck and Biochrom

  Issue: July 31, 2013
  Category: Upstream, Downstream
  
  
  Following the completed acquisition of Biochrom AG, Merck can now offer a combined innovative product range. Our comprehensive capabilities feature liquid cell culture media and buffers, including serum-free products.
  Read more »

• Coming soon to Darmstadt: our new R&D center for formulation

  Issue: June 20, 2013
  Category: Bioavailability, Formulation, API
  When our new excipient research laboratories open in Darmstadt in Q1 2013, we'll be able to provide even better support for your pharmaceutical formulation – with ultra-modern equipment, a wide range of progressive technologies, and highly qualified.
  Read more »

• EMPROVE® bio continues to grow – with TRIS HCl and Gua HCl

  Issue: June 20, 2013
  Category: Downstream, Upstream
  In the past, TRIS hydrochloride (used as a buffer during biochromatography, along with TRIS) and guanidinium chloride (used for dissolving inclusion bodies and purifying chromatography resins) were available in technical qualities only.
  Read more »

• Fewer refusals: Merck now offers group audits

  Issue: June 20, 2013
  Category: Regulatory Topics, Merck Topics
  At Merck, we take openness and transparency seriously. We see our customers as partners with whom we collaborate closely – and providing insights into manufacturing processes and quality assurance is an integral part of this relationship.
  Read more »

• How authorities and enterprises are reinforcing the safety of the pharmaceutical supply chain

  Issue: June 20, 2013
  Category: Regulatory Topics
  As recent years have shown, falsified medicinal products and sub-standard raw materials are a big problem in today's globalized pharmaceuticals market. After all, the reputation of suppliers and producers – and more important still, patient safety.
  Read more »

• How Parteck® SI and Candurin® make your tablets stand out

  Issue: June 20, 2013
  Category: Formulation
  These days, tablets need to be robust, firm, release their actives quickly ... even looks matter! With so many boxes to tick, it's no wonder demands on production processes are growing too.
  Read more »

• New – in EMPROVE® api quality

  Issue: June 20, 2013
  Category: API
  Two more Merck products now offer tailor-made documentation for swift, smooth approvals, and can be used without hesitation in the field of active ingredients: magnesium chloride hexahydrate cryst and calcium chloride dihydrate.
  Read more »

• Optimized TRIS now available in new purity grade

  Issue: June 20, 2013
  Category: Downstream, Upstream
  In our book, the best way to improve performance is by avoiding complacency, and continuously monitoring and challenging your own processes. Take TRIS, for example – a buffer for pH adjustments in downstream purification.
  Read more »

• Our cell culture media milling technology in Darmstadt

  Issue: June 20, 2013
  Category: Upstream
  As everyone knows, a chain is only as strong as its weakest link. That's why at Merck, we value the quality of raw materials and good formulation so highly. Stable, reliable production processes are vital too – for instance when manufacturing.
  Read more »

• Our new Square Boxes are more than just containers

  Issue: June 20, 2013
  Category: Merck Topics
  Square, practical, innovative ... our new Square Boxes have several advantages over conventional plastic drums. Take transport, for example: The footprint of 37 × 37 centimeters is perfect for CP 5 palettes; the capacity of 52 liters is higher...
  Read more »

• Part of the pilot phase: Rx-360 audits Merck

  Issue: June 20, 2013
  Category: Regulatory Topics
  Our world is converging. The pharmaceutical industry and raw material suppliers have been feeling the effects for years – and are responding with various initiatives designed to create global standards and cooperation for quality and safety.
  Read more »

• Parteck® Mg DC now available in EMPROVE® grade

  Issue: June 20, 2013
  Category: Formulation
  We now offer Parteck® Mg DC, our directly compressible magnesium hydroxide carbonate, as an EMPROVE® product. This product takes the load off machines by ensuring high densities even at low compression rates, while the high mineral content means.
  Read more »

• Ready for tomorrow: our new production plant for inorganic salts

  Issue: June 20, 2013
  Category: Formulation, Regulatory Topics, Merck Topics
  As a supplier of inorganic salts, the best way to meet increased demand tomorrow is by being one step ahead today. That's why we've invested in an ultra-modern production plant for inorganic salts in Darmstadt.
  Read more »

• Two new products make the grade: IPTG and Poloxamer 188

  Issue: June 20, 2013
  Category: Upstream, Downstream
  After completing our rigorous supplier qualification process, we're proud to announce two new products in our range. Isopropyl-?-D-thiogalactopyranoside (IPTG) is used for bacterial fermentation, particularly of E.-coli bacteria.
  Read more »

• Work more efficiently – with CellPrime™ animal-free products

  Issue: June 20, 2013
  Category: Upstream
  Life originates from a single cell; and ideally, new products originate from cell cultures. So when you're working with cell culture media in research or production, batch-to-batch consistency and reproducible results are vital.
  Read more »

• EMPROVE® api protects drug approvals with gapless documentation

  Issue: June 20, 2013
  Category: Regulatory Topics, Formulation, API
  Today's expectations in the pharmaceutical industry: getting to the market fast. Today's reality: complicated regulatory requirements which slow approvals and renewals down. EMPROVE® api helps to get expectations and reality closer together again.
  Read more »

• Join ChromaTALK™, our online forum for chromatography professionals

  Issue: June 20, 2013
  Category: Merck Topics, Downstream
  As part of the ChromaTALK™ community, your opinion matters. Wherever you are in the world, this interactive online forum gives you the opportunity to share your thoughts on the latest innovations, best practices, and the challenges the industry.
  Read more »

• Merck Probumin® – the No.1 BSA brand

  Issue: June 20, 2013
  Category: Upstream
  With over 50 years of experience in protein fractionation, Merck is the world's biggest manufacturer of top-quality albumins. And in the field of biopharma and in-vitro diagnostics (IVD), our Probumin® Bovine Serum Albumin (BSA).
  Read more »

• Mobius® MIX 1000 L mixer and Powder Delivery System

  Issue: June 20, 2013
  Category: Upstream
  With twice the capacity and all the features you expect from a Mobius® single-use mixer, the new Mobius® MIX 1000 L mixer saves biopharmaceutical manufacturers more time and effort than ever.
  Read more »

• More comprehensive GMP documentation in cell culture production

  Issue: June 20, 2013
  Category: Regulatory Topics, Upstream
  In the interest of patient safety, GMP provisions become more stringent in the EU. All steps in cell culture production of APIs will soon need to be documented and monitored to GMP standards from the master cell bank stage onwards.
  Read more »

• New: Parteck® ODT in EMPROVE® exp quality

  Issue: June 20, 2013
  Category: Formulation, Bioavailability
  Now that Parteck® ODT is an EMPROVE® product, customers will find it even harder to resist. This superior directly compressible, ready-to-use excipient is easy to formulate and handle, and permits up to 50 % active ingredients in direct-compressible.
  Read more »

• Our activated multi-arm PEGs

  Issue: June 20, 2013
  Category: Bioavailability, Formulation
  Some products are specialists, others get more versatile all the time – for example, activated multi-arm PEGs*. Thanks to Merck, these innovative developments are currently proving their value in the field of medical devices.
  Read more »

• Our new electronic change control management system

  Issue: June 20, 2013
  Category: Regulatory Topics
  At Merck, we understand that customers need to know right away when a process change affects the quality of the raw materials we supply. That's why we've just launched a new state-of-theart electronic change control management system.
  Read more »

• Sweet news with Sucralose

  Issue: June 20, 2013
  Category: Formulation
  With its sweet, sugar-like taste and high process stability, Merck sucralose is ideal for masking off-notes in liquids and solid formulations. And now that the European Pharmacopoeia declaration is available, this product really does tick all.
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• Quality first: EMPROVE® grade CaHPO4

  Issue: June 20, 2013
  Category: Forumulation
  As any manufacturer knows, microbiological contamination in CaHPO4 can seriously disrupt production schedules. So to minimize your risk and help you produce more smoothly, we now produce it ourselves – to the highest quality standards possible.
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• Success through collaboration: Merck Beijing Skywing

  Issue: June 20, 2013
  Category: Upstream
  As the acknowledged expert for processes and bioreactor construction in China, Merck Beijing Skywing offers a personal, start-to-finish service that helps animal health companies develop vaccine production processes more efficiently.
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• The benefits of our crystalline DOTAP

  Issue: June 20, 2013
  Category: Bioavailability, Formulation
  DOTAP containing liposomes are well established for in-vitro experiments. Our crystalline-grade DOTAP is also suited for in-vivo transfection of polynucleotides – and can even be used as an adjuvant to stimulate immune response in vaccine.
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• Activated PEGs for protein PEGylation

  Issue: June 20, 2013
  Category: Bioavailability, Formulation
  The body's immune system and enzymatic processes can degrade and metabolize proteins. As a result, the duration of action of therapeutic proteins is often rather short. Fortunately, researchers have found a way to prolong the desired efficacy.
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• Audits have started at our Inorganic Salts Production Plant

  Issue: June 20, 2013
  Category: Formulation, Merck Topics, Regulatory Topics
  Our state-of-the-art plant in Darmstadt is running smoothly, and is open for onsite audits. Your business partner will be happy to inform you about our audit procedures.
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• Bioavailability enhancement solutions from Merck

  Issue: June 20, 2013
  Category: Formulation, Bioavailability
  Merck offers broad experience and deep application know-how in the field of bioavailability enhancement. As a full-service provider, we have everything you need to optimize development and reduce time to market.
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• Cellvento™ CHO-100 cell culture media

  Issue: June 20, 2013
  Category: Upstream
  Designed especially for fed-batch mode, our new Cellvento™ CHO-200 medium, together with its complementary feeds, is the perfect match for Cellvento™ CHO-100.
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• Bioavailability enhancement – the key to success for pharmaceutical drug products

  Issue: June 20, 2013
  Category: Bioavailability, Formulation
  Poor bioavailability is a hot topic in the pharmaceutical sector. While novel APIs, including biological molecules such as proteins and peptides, are particularly prone, API reformulations can also be affected.
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• Cell culture media specialist Biochrom joins Merck

  Issue: June 20, 2013
  Category: Upstream, Downstream
  With the upcoming acquisition of Biochrom AG*, we look forward to offering pharmaceutical and biopharmaceutical manufacturers even more ways to reduce the complexity of production. Biochrom's innovative product range features liquid cell culture.
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• CellPrime™ r Insulin now available

  Issue: June 20, 2013
  Category: Upstream
  Thanks to an exclusive agreement with our partner Julphar, supplies of our top-quality recombinant human insulin are now available under the Merck CellPrime™ brand name. This advanced product is the perfect complement for our existing range.
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• m,p-Xylene from Merck

  Issue: June 20, 2013
  Category: Formulation
  We are pleased to announce that we have relaunched m,p-Xylene (mixture of isomers) to complement our broad range of excipients. Manufactured in accordance with cGMP regulations, Merck m,p-Xylene consists of a unique isomeric composition.
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• Our EMPROVE® quality PVA

  Issue: June 20, 2013
  Category: Formulation, Bioavailability
  Although polyvinyl alcohol (PVA) is such a familiar product, it always pays to order it from Merck. There are three good reasons for this: consistent quality, purity, and strict regulatory compliance.
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• Our Globally Harmonized Labels

  Issue: June 20, 2013
  Category:Merck Topics, Regulatory Topics
  In a global business like pharmaceuticals, manufacturers need universal standards and procedures that are accepted all over the world. That way they can ship products they source in one region anywhere else – knowing there will be no problems on.
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• Our organic and inorganic buffer range

  Issue: June 20, 2013
  Category: Upstream, Downstream
  When it comes to optimizing your protein's pH value – and stabilizing it while protecting it from contamination – Merck buffers are ideal.
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• Parteck® ODT formulations with an aqueous coating

  Issue: June 20, 2013
  Category: Formulation, Bioavailability
  Who says you can't have it both ways? Now you can even coat the tablets you create with Parteck® ODT – without affecting their disintegration rate.
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• Under the new GDUFA program, manufacturers support FDA targets

  Issue: June 20, 2013
  Category: Regulatory Topics
  To reduce the growing backlog of approval applications from generics manufacturers, the FDA has recently introduced a five-year program called the GDUFA (Generic Drug User Fee Amendment). Under the new scheme, the FDA is authorized to collect fees
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• With our two new chromatography products

  Issue: June 20, 2013
  Category: Downstream
  With the addition of two new products, our chromatography portfolio is now broader than ever – and we're committed to expanding it continuously. PharmPrep® P 100 RP18e sorbent is our latest silica sorbent.
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• The EXCiPACT™ certification scheme

  Issue: June 19, 2013
  Category: Regulatory Topics
  
  
  When patient safety is your top priority, it clearly makes sense to verify all the ingredients in medications, not just some of them. Yet while active pharmaceutical ingredients are strictly regulated, there is still no formal legislation.
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• New EMPROVE® api products: Urea cryst. and Potassium chloride

  Issue: June 19, 2013
  Category: API
  
  
  Since urea is so popular in skin creams and dermatological applications, we decided to help customers stay on the safe side – by becoming the first supplier to offer urea in EMPROVE® api quality with even higher purity.
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• Our glycine in EMPROVE® exp quality

  Issue: June 19, 2013
  Category: Formulation
  
  
  With so many customers seeking reliable supplies of top-quality glycine, we decided the best solution was to produce it ourselves – in Germany. As a result, you can now order Glycine EMPROVE® exp – straight from us, the manufacturer.
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• The new Falsified Medicines Directive

  Issue: June 19, 2013
  Category: Regulatory Topics
  
  
  Falsified medicines are a major threat to global health and safety. Most of them are fake products that masquerade as the real thing, but can be much stronger or weaker – and are usually of dubious quality.
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• Low dosage and Parteck® M

  Issue: June 19, 2013
  Category: Formulation
  
  
  Did you know? One in five oral formulations now contains highly potent APIs in extremely low dosages. For tablet manufacturers, these 'highly potents' can be highly challenging too: the particles of low-dose APIs are far smaller.
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• CellPrime™ recombinant human lysozyme – for in-culture protein extraction

  Issue: June 19, 2013
  Category: Upstream
  
  
  As any specialist will confirm, expressing protein in a bacterial system is easy; the hard part comes afterwards, when you need to extract it in a functional form. Now there's a new Merck product that meets this challenge and can improve.
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• How our API-grade meglumine enhances bioavailability

  Issue: June 19, 2013
  Category: Bioavailability, Formulation, API
  
  
  When you consider how closely organic counter-ions like meglumine interact with the drug substance itself, it obviously makes sense to use the best quality you can find. And when you order from Merck, you can be sure of getting the finest.
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• Extractables study for packaging of GMP solutions

  Issue: June 19, 2013
  Category: Downstream
  
  
  At Merck, we believe in doing things properly. So when biotech customers asked us to verify the leach resistance of the containers we use for CiP and process solutions, we responded right away.
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• The new Mobius® CellReady 200 L bioreactor

  Issue: June 19, 2013
  Category: Regulatory Topics, Upstream
  
  
  Looking for a single-use bioreactor that's reliable, robust, and easy to use? Our new Mobius® CellReady 200 L fits the bill perfectly. Designed to deliver reliable mammalian cell culture performance at pilot and clinical scale.
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• Our DMEM/F12 makes the difference

  Issue: June 19, 2013
  Category: Upstream
  
  
  Just because it's a standard medium doesn't mean it comes with standard levels of quality and support. Take DMEM/F12 (for CHO media developments).
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• Rebranding our portfolio with the new Merck logo

  Issue: June 19, 2013
  Category: Merck Topics
  
  
  How do you eat an elephant? One bite at a time, according to the old saying. We don't know if that's true – but it certainly works for the 'mammoth' task we are currently involved in: rebranding our whole portfolio with the new Merck logo.
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• Growing together: Merck and the Chinese market leader for cell culture media

  Issue: June 18, 2013
  Category: Upstream, Merck Topics
  
  
  'X xùn!' is Chinese for 'good news.' So why are we brushing up on our Asian language skills? Because Merck has recently acquired the Chinese market leader for animal origin free cell culture media, a company called Beijing Skywing Technology.
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• Why does Merck have more than one EMPROVE® portfolio?

  Issue: June 18, 2013
  Category: Regulatory Topics, API
  
  
  You can't use diesel if your car needs gasoline – and you can't use excipientgrade raw materials for demanding API applications. So to make life easier (and prevent costly mix-ups), Merck offers separate EMPROVE® portfolios for both fields of work.
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• Merck hosts the first Rx-360 Consortium global open day meeting

  Issue: June 18, 2013
  Category: Regulatory Topics
  
  
  In our book, the best way to keep counterfeit materials out of the global pharmaceutical supply chain – and hence ensure patient safety – is by building and monitoring a global quality system.
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• Preventing the spread of foot-and-mouth disease

  Issue: June 18, 2013
  Category: Upstream, Merck Topics
  
  
  It's been nine years since the last outbreak of foot-and-mouth disease swept Latin America, the UK, and mainland Europe. But as a recent FAO report indicates, there is still a real danger of contamination for microbiological culture media.
  Read more »

• Is there a recipe for excellence?

  Issue: June 18, 2013
  Category: API
  
  
  Our Analytics service has an outstanding reputation for reliable, tailor-made service – but why, exactly? We asked Dietmar Oeter, Ph.D., for an impromptu analysis of what makes his own team so successful.
  Read more »

• Independent audit certifies the Eshmuno® management systems

  Issue: June 18, 2013
  Category: Downstream
  
  
  As anyone who's had their passport photo taken knows, impartial instruments are seldom flattering. Sometimes, though, that objective view is just what you need.
  Read more »

• Challenging the economies of scale in mAB production

  Issue: June 18, 2013
  Category: Upstream
  
  
  Demand for vaccines and biosimilars is increasing all the time.* So how come biomanufacturing is talking about overcapacity instead of struggling to keep up? Answer: As upstream titer yields are now so high, there's no need for all that capacity.
  Read more »

• Our all-round approach to high-productivity downstream purification

  Issue: June 18, 2013
  Category: Downstream
  
  
  It's often said that ion exchange chromatography is the 'workhorse of column chromatography.' Actually, though, our latest products and solutions are more like a racehorse: powerful, lean, and purpose-built for speed an performance.
  Read more »