Services Videos & On-Demand Webinars

Nov | 2017

• Presenters: Shawn R. Smith, Associate Director, Marketing, BioReliance® End-to-End Solutions, Merck; Jerome Pionchon, Engineering Expert, BioReliance® End-to-End Solutions, Merck; and Dennis Powers, Director of Sales Engineering, G-CON Manufacturing
• Abstract

  Biopharmaceutical companies on the verge of investing into manufacturing or facilities expansion face many questions and challenges. Speed, agility, and flexibility are becoming more critical to executing their changing production and distribution strategies. Platform facility designs which integrate the latest procss technologies wthin innovative pre-fabricated cleanrooms are critical for addressing the trending desire to implement 'clonable' modular facilities that can be delivered in a timely fashion across multiple locations. Companies like Merck KGaA, Darmstadt, Germany and G-CON Manufacturing are working together to combine their technologies and develop simple yet robust platform solutions for industry.
  
  As bioprocessing technologies intensify performance, volumetric requirements become less. As such, 2000L single-use bioreactors - or multiple bioreactors of similar or less volumes - now suffice for the production of novel or biosimilar recombinant proteins. Such a shift in the industry enables the development of more mobile, modular facility designs. We will describe the rationale for this collaboration and its result: a turn-key solution that integrates a templated process train with a rapidly-deployable facility platform. By combining the unique advantages found with the G-CON POD construction and the bioprocess technology expertise from within Merck KGaA, Darmstadt, Germany, the goal of creating a cost-effective, pre-fabricated alternative to historical 'stick built' facilities is being achieved. Additionally, the flexibility inherent to our approach provides for a greater configurability that confers more user-specified choice into the selection of options. Simple in concept, this solution is also robust, cost-effective, and conducive to tight timelines for implementation. In this webinar you will learn:
  
  

  • Basic options for facilities/capacity expansion
  • The value of templated process trains employing single-use equipment
  • How modular, prefabricated PODs® outfitted with such single-use bioprocessing equipment represent an attractive, cost-effective strategy for capacity expansion
    
    

  POD® is a registered trademark of G-CON Manufacturing, Inc.

Oct | 2017

• Presenters: Ashley O’Brien, Manager, VPC Team, Provantage® Lab Services; and Stephanie Ferrante, Associate Director of Biosafety Technology Management
• Abstract

  Filtration of liquids through sterilizing grade filters is a common method for removing microorganisms from small volume parenterals that are heat-sensitive. Final filtration with a 0.22 µm diameter filter is the last unit operation in the process and is a critical step for successful manufacturing. Regulatory requirements and industry best practice offer insight into assuring that this critical unit operation is effective. A comprehensive validation strategy provides the scientific evidence to confirm process conditions and filters are robust, and to defend these decisions to regulatory authorities. The authors will focus on the filter sterilizing step, cite relevant guidance and provide an example of how to assure this critical step is effective for a representative drug product.
  
  In this webinar, you will learn about:

  • The importance of sterilizing grade filters for removal of microorganisms from small volume parenterals
  • Why this last unit operation in the process is a critical step
  • How to make it effective for successful manufacturing
  • How a comprehensive validation strategy can provide scientific evidence to help with regulatory authorities

Oct | 2017

• Presenters: Dr. Elie Hanania, Ph.D., Head of Process Development, BioReliance Services; Dr. Marian McKee, Senior Director and Head of Global Operational Development Services, BioReliance Services; and David Backer, Head of Commercial Development
• Abstract

  Come learn more about our integrated approach to ensure viral vector and gene therapy commercial readiness. We will discuss topics relating to process development for viral vector manufacturing, biosafety testing and commercial readiness.
  
  Significant progress has been made for the use of viral vectors for gene therapy. Promising clinical trial results as well as recent FDA approval for CAR-T cell therapy to treat certain children and young adults with B-cell lymphoblastic leukemia have signaled advancements in the field. This marks a historic action, providing opportunities for new viral vector technologies to transform medicine and the way patients are treated and even cured. The need for process development for viral vector manufacturing to improve yield to meet patient demand, biosafety testing for product characterization, potency and safety and commercial readiness to accelerate therapy to-market are critically important. Here, we emphasis an integrated approach that allows our customers solutions to ensure viral vector and gene therapy commercial readiness to meet the growing market need.
  
  In this webinar, you will learn:

  • Process development advances for production scale-up of viral vectors for gene therapy
  • Methods specific for viral gene therapy product characterization, purity, potency, safety and release testing
  • Commercial readiness through our US and UK Centers of Excellence for viral product manufacturing

Oct | 2017

• Presenter: Jeroen Bakker, PhD, M Ventures for Healthcare
• Abstract

  Our Life Science business is fully dedicated to supporting small, biotech companies with cutting edge technologies. Besides technical aspects of molecule development and production, fundraising is omnipresent. This webinar will provide insights and perspectives from Merck Ventures, BV, a subsidiary of Merck KGaA, Darmstadt, Germany.
  
  At Merck Ventures, the strategic corporate venture capital arm of Merck, we drive innovation and back entrepreneurs through equity investments and handson support. We focus on areas that impact the vitality and sustainability of our current and future businesses.
  
  This webinar will provide you with the ABCs of venture capital including:

  • How venture capital works
  • The role of a corporate venture capital
  • How we look at opportunities

Aug | 2017

• Presenter: Dr. Afshin Sohrabi, Senior Scientist, BioReliance Development Services
• Abstract

  Learn about existing and emerging methods to accelerate biosafety testing of biologic therapies.
  
  Speed to market for biologic therapeutics is ever more critical. However, the critical safety tests for these molecules, for example screening for adventitious agents such as viral contaminants, can be time consuming as well as challenging and laborious. Join us for this webinar as we explore how rapid methodologies are being used to not only accelerate this process, but also enhance quality by reducing testing complexity. Existing technologies as well as emerging trends will be discussed, along with the implications these may have on the regulatory landscape.
  
  In this webinar you will learn:

  • Which existing and emerging technologies are having now, and will have in the future, an impact on biosaftey testing.
  • The benefits as well as risks of employing rapid methods for biosafety screening.
  • How the regulatory agencies are reacting to rapid testing methods as alternatives to existing methods.

July | 2017

• Presenter: Marian McKee, Ph.D., Sr. Director, Head Global Operational Developmentology
• Abstract

  This webinar will discuss the rise of AAV as a popular vector in gene therapy applications and explore the biology of the vectors and their use in various gene therapy productions systems.
  
  The need for thorough characterisation and biosafety testing of the vectors will be discussed, including the current Regulatory opinion on testing of such vectors. The various methods used to characterise and test vectors will be presented, with emphasis on how the test methods address the regulatory requirement for these therapies.
  
  In this webinar, you will learn:

  • Regulatory requirements for viral vector and cell bank characterization
  • Devising testing strategies to ensure global regulatory acceptance of a gene therapy products
  • Emerging issues and concerns in gene therapy testing.

April | 2017

• Presenter: Bob Young, Program Consultant and Study Director, In Vivo Mutation
• Abstract

  Discover solutions for early phases of product development for genetox assessment with high-throughput screening assays that will assist in product characterization, while saving time and money. Our team of BioReliance® Genetic Toxicology experts will share specifics and rationale for each assay. 
  
  In this webinar you will: 

  • Learn available high-throughput Genotoxicity screening assays 
  • Understand what each assay is measuring and why Mechanism of Action (MOA) is important 
  • The validation results of each assay (sensitivity, specificity, comparability, and predictivity) 
  • Learn how to employ HTP assays into your research 

March | 2017

• Presenter: Colette Côté, PhD, Principal Scientist, BioReliance Next Generation Sequencing
• Abstract

  The use of Next Generation Sequencing (NGS) for GMP Virus Bank screening has several distinct advantages over traditional sequencing and culture methods – especially for more challenging virus types. The de novo sequencing power of NGS allows for the screening of adventitious agents, such as mycoplasma, bacteria or other viruses. This is of particular use where the generation of neutralizing antibodies is problematic, e.g. Zika or Dengue. 
  
  In addition, due to the richness of the dataset, NGS allows for the detection of genetic changes or other subpopulations in viral seed stocks. Presentation of this data is of particular interest, and in some cases required by the regulators. 
  
  Key learnings:

   
  • An overview of the regulatory requirements for the screening of GMP viral banks 
  • Strategies for viral bank adventitious agent testing – the needle in a haystack of needles 
  • Challenges with using NGS to analyze genetic changes, sub-population quantification and rare variant detection in viral seed stocks 
  • Considerations for validating a GMP compliant NGS workflow 
  • How to best use remote parallel computing, the Cloud, for rapid scalability and analysis. Including an overview of data security and integrity 

Feb. | 2017

• Presenter: Rohan Kulkarni, Ph.D., ERT, Director Toxicology, Study Management
• Abstract

  Discover solutions for all phases of product development for genetox assessment from in silico analysis, screening, mode of action assessment, or GLP regulatory required assays. Our BioReliance® Genetic Toxicology Services director will share specifics and rationale for each assay category. 
  
  In this webinar you will: 

  • Learn the required regulatory assays 
  • Understand why each assay is used and how to employ different assay designs 
  • Learn different assays and techniques to screen potential compopunds and understand mechanism and mode of action 

Feb. | 2017

• Presenters: Kathleen Sousa, R&D Manager, Virology & Microbiological Sciences; Sal Giglia, Filtration Applications Manager; and Ashley O'Brien, VPC Team, Provantage Lab Services 
• Abstract

  The ability of microporous membranes to reliable retain microbes in pharmaceutical applications was established in the early 1980’s, enabling access to safe pharmaceutical and biopharmaceuticals that, had it not been for sterilizing filtration, would not be available to us.
  
    While the theoretical foundation of microbial retention by sterilizing grade membrane filters has not changed, advances in technology allow us to better understand the mechanisms and predict its performance. Still, end users and regulators require empirical evidence that drug product does not impact the ability of the membrane to retain microbes. 
  
  In this webinar, our presenters will: 

  • Review the scientific foundation of the bacterial retention test 
  • Illustrate how sterilizing membranes function 
  • Apply the bacterial retention test to a modern drug product in a case study 
  • Understand specific challenges and eliminate them to assure the integrity test can be performed correctly the first time

Sept. | 2016

• Presenter: Madhav Paranjpe, DVM., MS., Ph.D., DACVP, Director of Pathology and David Jacobson-Kram, Ph.D., Former Associate Director for Pharmacology and Toxicology, CDER, USFDA
• Abstract

  Carcinogenicty testing for pharmaceuticals with transgenic mouse models has been approved by the International Conference for Harmonisation (ICH) since 1997. As a result, the US FDA and other worldwide regulatory agencies accept 26-week transgenic mouse models as alternatives to traditional 2-year studies. At present 75% of all mouse studies submitted to the FDA are being conducted in the Tg.rasH2model. Focusing on the predominant Tg.rasH2 model, which is accepted for both genotoxic and non-genotoxic compounds, this overview of Carcinogenicity Assessment will cover the history, validation and testing experience with transgenic mouse models for carcinogenicity assessment. 
  
  By watching this webinar, you will know more about: 

  • The differences between traditional 2-year studies and 26-week transgenic mouse studies 
  • Experience with the Tg.rasH2model, design and optimization of the studies and their interpretations 
  • BioReliance's robust historical database of spontaneous lesions 
  • Experiences and guidance on regulatory review from the former head of the Carcinogenicity Assessment Committee (and Executive CAC) at the FDA 

Sept. | 2016

• Presenter: Guillaume Plane, Global Development and Marketing Manager, Biodevelopment Services, Merck
• Abstract

  Are you involved with planning tech transfer of your drug product? Join this webinar to learn more about the regulations and considerations you need to consider and learnings from a case study.

  According to ICH Q10, “The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach, and ongoing continual improvement.”

  As a result, there is an expectation for transfers to be performed in an organized, methodical manner with appropriate documentation. It is also expected that they happen between one Process Development group to another or to a Pilot Lab, from Process Development lab to clinical or commercial manufacturing, or from Process Development to external clinical manufacturing. Lastly, they may also happen between two company facilities at commercial scale, or between a company and an external contract manufacturing at commercial scale.

  This presentation will cover points to consider for successful tech transfers with a focus on cGMP training requirements, and include lesson learned from real cases.

  In this webinar you will learn:

  • Regulations guiding tech transfer procedures
  • How to succesfully plan a tech transfer
  • How Provantage® End-to-End Services can help you succeed

Sept. | 2016

• Presenters:
  
  • Thomas Broschard, Associate Director Toxicology, Merck
  • Christian Heiss, Head of Provantage® Laboratories, Merck
• Abstract

  Preserving patient safety, while adapting single use systems into the drug development and production process, is a priority for the healthcare industry and regulatory authorities. Along with increased single use system use, awareness of the potential for harmful substances to migrate from single use systems into drug product, potentially compromising patient safety, is growing.

  To mitigate the toxicological risk and gain the benefits single use systems offer, patient safety assessments are being performed. The quality and efficacy of these evaluations is highly dependent upon the identification and quantification of all of the potential compounds that may leach into the drug product. As a result, the use of advanced analytical technology is crucial to conducting a thorough patient safety assessment.

  During this webinar, we will discuss:

  • The principles of patient safety assessment
  • Description of what data is required to conduct a patient safety assessment
  • Comparison of the analytical tools that are commonly used to produce the data
  • Necessity for use of LC and GS (advanced analytics) to assure a thorough understanding

  Additionally, we will present example of key information that may be missed when advanced analytics are not used.

Aug. | 2016

• Presenter: Dr. Martin Wisher, Global Head of Regulatory Affairs, Merck KGaA, Darmstadt, Germany
• Abstract

  Biopharmaceuticals are manufactured through complex biochemical process utilizing living systems, and require multiple steps to purify, increasing the risk of extensive batch-to-batch variability.

  The more complex process of creating a generic version of a biologic has resulted in regulators defining the replicate drug as similar, but not identical, resulting in the globally accepted term “biosimilar”.

  Regulatory authority guidance highlights:

  • “To demonstrate that the biosimilar has a highly similar quality profile when compared to the reference medicinal product”
  • “When assessing whether products are highly similar, manufacturers should consider a number of factors…”

  The factors for consideration include cell expression system, manufacturing process, impurities, assessment of physicochemical properties, and stability studies, among others.

  This webinar will review regulatory expectations in assessing the comparability of biosimilars through protein chemistry techniques and cell based bioassays. Key considerations for developing robust bioassays for biosimilar comparison will be presented.

April | 2016

• Presenter: Sue Walker, Product Manager, Formulation and Final Fill Applications, Merck
• Abstract

  In general, the plasma industry is facing pressure to provide a safe, efficacious and secure supply of plasma products on a worldwide basis while at the same time, there is limited capacity for processing. One solution for this problem that is gaining acceptance in the biopharmaceutical industry is the use of flexible facilities containing single use equipment. But operations focusing on plasma processing face some unique challenges that can impact the implementation of single use technologies including batch sizes, historical fractionation processes and large scale chromatography.
  
  A facility design exercise utilizing a combination of single-use technologies and classical stainless steel equipment can represent an attractive option for plasma applications to address these unique challenges.
  
  This webinar will discuss considerations for the implementation of single-use technologies for plasma applications and facilities focusing on operational flexibility, overall process timing and economics.

April | 2016

• Presenter: Sébastien Ribault, Director of Provantage® BioDevelopment, Merck
• Abstract

  As many biologics will or have come off patent, the opportunity for competition, and potentially lower biologics costs through biosimilars, is created. Barriers to entry, the main one being product manufacturing as relatively minor changes in the process may impact quality or safety, exist. Coupled with the need for manufacturing flexibility and agility for commercial success, you are faced with a challenging dichotomy.
  
  In this webinar, we will discuss the challenges you face in designing and constructing a single production facility that can produce different biosimilar monoclonal antibodies, from clinical studies through commercial production. We will look forward 10 to 15 years and consider different production scales utilizing SU equipment in conjunction with flexible facility design, and potential economic impacts.

Dec. | 2015

• Presenter: Pamela Napolitano, Validation Project Coordinator, Merck
• Abstract

  Drug manufacturers consider the potential impact of extractables on productivity and patient safety a major concern when implementing single use process technology. Application of single use technology now spans from cell culture to final fill making it more challenging to determine what to test, when to test and what to do with the resulting data. In this webinar, our extractables and leachable experts will review industry guidance and advances in best practices in the context of a case study that will leave you better prepared to deal with this challenging issue.

Nov. | 2015

• Presenters: Sébastien Ribault, Director Provantage® BioDevelopment, Merck and Christian Cattaruzza, Marketing Director of Provantage® End-To-End Services, Merck
• Abstract

  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 phases. These critical steps may take several days or even weeks, and can results in delays if a contamination occurs.

  Join us for this webinar as we explore:

  • The comparison of stainless steel, glass and disposable equipment showed how comparable they are regarding titers
  • Molecule quality and how different they are regarding organization and financial aspects
  • Operator feedback on the ease of use and the necessary changes in the GMP area to introduce SUBs are
  • The integration in a flexible factory

July | 2015

• Presenter: Guilaume Plane, Development and Marketing Manager, Merck
• Abstract

  In the drive to develop a new drug product quickly and efficiently, biopharmaceutical developers need to find a partner who has experience not only with manufacturing equipment, but who also has a proven track record of in delivering Process Development and GMP manufacturing services. Join us to learn how Merck can support your efforts—from our newly launched Provantage® Clone Generation Service and Clinical Scale drug production, through to our complete Provantage® End-to-End solution.