Harvest Videos & On-Demand Webinars

Nov. | 2016

• Presenter: Michael Felo, Director Mobius Single-Use, Merck
• Abstract

  Single-Use systems, enabling faster more cost effective bio-pharma manufacturing, must also meet high quality parameters and standards while conducting component qualification, manufacturing operations, inprocess testing, and final product release.

  For single use systems, quality control during the manufacturing process is critical. In a traditional stainless-steel system, the end user has significant control over the design, construction, qualification and validation, and maintenance of the system. When implementing a single-use system, the supplier of the single use product takes responsibility for many of these functions from the user. It is therefore important that the single use supplier has established and follows a strong quality control system. This presentation will highlight the quality systems, processes, facilities, and personnel required to assure the performance, robustness, and sterility of single use systems.

  In this webinar you will learn:

  • The process used to qualify components, suppliers and sub-suppliers
  • Managing documentation control, change control, process particulate control, risk mitigation practices
  • See examples of Extractables Testing, Validation of MFG processes, MFG Controls, Sterilization Qualification, Realease Testing and Certification, Integrity Assurance

Nov. | 2016

• Presenter: Emily Peterson, Biomanufacturing Engineer, Merck
• Abstract

  Strategies to overcome key limitations and challenges such as higher molecular osmotic pressure and lower membrane permeability when customizing small molecule (3-10 kDa) TFF processing.

  Due to their higher osmotic pressures and mass transfer coefficients, small molecules in the range of 3 – 10 kDa, like insulin, often require unique processing conditions as compared to those of larger molecules. TFF processing strategies developed for larger molecule applications may not be appropriate and can lead to an increase in process variability and sub-optimal performance.

  This webinar explores:

  • The key limitations and challenges typically observed with small biological molecule TFF processing
  • Explains the strategies required for optimal success with your TFF step

Oct. | 2016

• Presenter: Julie Murrell, Head of Cell Therapy Bioprocessing, Merck
• Abstract

  This webinar reviews the findings of a recent survey conducted by the Economist Intelligence Unit and presents ways to navigate tomorrow's complex biopharma landscape in order to make novel therapies a reality.
  
  A recent survey conducted by the Economist Intelligence Unit highlights the new products that the biopharma industry identifies as most disruptive to their growth strategies in the next five years. The findings raise a challenge to biopharma to go beyond barriers to bringing new products to market by presenting ways to overcome these hurdles and make novel therapies a reality.

  In this webinar you will learn:

  • The impact of novel therapies on biopharma growth strategy
  • Manufacturing challenges associated with novel therapies
  • How to overcome barriers to bringing novel therapies to market

Oct. | 2016

• Presenter: Claire Scanlan, Process Development Scientist (PDS) & Manager for Central PDS Region in North America, Merck
• Abstract

  One of the most critical steps in a vaccine manufacturing process is clarification, particularly harvest or lysate clarification.

  The methods employed can vary greatly due to:

  • The production system used
  • Product being harvested
  • The nature of the properties of the process fluid

  Centrifugation and/or microfiltration has historically dominated the vaccine process landscape, but the advent of newer normal flow filter options and the increased desire for disposable/single-use processes have expanded vaccine clarification choices.

  This webinar will detail the various clarification methods that can be successfully used for three vaccine types: viral, bacterial and polysaccharide vaccines. We will also focus on the wide-ranging uses of a novel depth filter for the efficient clarification of multiple vaccine types.

Jan. | 2016

• Presenter: Kenneth Muzykewicz, Director of Membrane Process and Technology, Merck
• Abstract

  Changes happen. Suppliers go out of business. Plants consolidate. Drug product lifecycles exceed the lifecycles of the raw materials on which they’re reliant. We are committed to controlling, managing and communicating changes in the most stringent and highest quality manner to ensure your security of supply. In this webinar, Kenneth Muzykewicz will provide you with an overview of our change control process for critical raw materials within our filters.

  Join us for this webinar as we will focus on our:

  • Validation strategy & philosophy
  • Step by step approach to validation
  • Success criteria

  And learn how we:

  • Demonstrate no adverse effect on product performance
  • Define equivalence
  • Minimize the impact of change on your process

Nov. | 2015

• Presenter: John Amara, Ph.D. Senior Scientist, Biopharm Process Solutions R&D, Merck
• Abstract

  Recent advancements in the productivity of upstream cell culture processes for the manufacture of therapeutic proteins, including monoclonal antibodies (mAbs), has resulted in greatly increased cell densities and higher levels of process-related impurities. These trends are placing an increased demand on existing harvest clarification technologies to remove biomass, including whole cells, cellular debris, and associated colloidal matter. Current depth filters may demonstrate an insufficient filtration capacity for these applications and often comprise naturally-derived components which require increased flushing to remove undesired organic and inorganic extractible components.
  
  Join us for this webinar as we report the design and performance characteristics of a novel synthetic depth filtration media that demonstrates a greatly increased filtration capacity and decreased effluent turbidity for the clarification of mAb from CHO-S harvests. When compared to commercial depth filtration media derived from natural components, this synthetic depth filter media is shown to have significantly decreased organic extractables and reduced WFI flushing requirements by TOC analysis. As an added benefit, this novel media is also shown to impart a modest HCP clearance capability through an adsorption mechanism. The impact of HCP clearance from the clarification step on several downstream process purification steps, including protein A capture chromatography and flow-through anion exchange chromatography will also be briefly explored.

Sept. | 2014

• Presenter: Kara Pizzelli, Manager of Process Develoment, Clarification, Merck
• Abstract

  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 is a common approach at scales up to 2000 L. Despite the proliferation of template approaches for purification of monoclonal antibodies, the process development activities for clarification unit operations can still be challenging in terms of designing a small scale experiment which is representative of the large scale. This is because it is not possible to know in advance of the small scale trials which ratio of primary to secondary clarification filter to use, the appropriate flow rate to use and when breakthrough will occur on the two filters. Please join us as we discuss how to best standardize the process development approach for a two step clarification process to ensure the development of a robust, scalable unit operation while minimizing the necessary amount of process development work.

Jan. | 2014

• Presenter: Nripen Singh, Senior Research Scientist, Merck
• Abstract

  Increasing cell culture densities and productivities during therapeutic protein (MAbs) production are placing a larger burden on downstream clarification and purification operations due to higher product and impurity levels. Traditionally, centrifugation and a combination of filtration techniques (tangential-flow filtration and depth filtration) have been widely used for clarifying these pretreated cell culture broths. However, the increased cellular debris present in these complex feed streams can prematurely foul the membrane and commercially available depth filters, adversely impacting their capacity and throughput. In this work, Merck has developed a cationic flocculant, Polydiallyldimethylammonium chloride (pDADMAC), as an effective pretreatment method for mammalian cell culture harvest which when coupled with Clarisolve® depth filters result in improved primary and secondary clarification for flocculated feeds. Potential benefits will be discussed, including more robust processing with a centrifuge and the potential to use filters in place of a centrifuge.