Extractables and Leachables Videos & On-Demand Webinars

Nov | 2017

• Presenter: Satish Kumar Mohanvelu, Marketing Manager, Emprove® Program; and Jessica Shea, E&L Global Technical Services Manager, BioReliance® End-to-End Solutions
• Abstract

  The successful adoption of single-use technologies in a biopharmaceutical process largely relies on confidently selecting the right components for use in the fluid path of a product, within a specific process. An important step in choosing such components requires generating an extractables profile, which can be done by carefully selecting the solvent streams and extraction conditions to model the product and process steps complemented with the right analytical strategy.
  
  In this webinar, you will learn:

  • An approach to adopt the BioPhorum Operations Group (BPOG) extractables protocol as a baseline testing strategy.
  • How to apply extractables data to a specific process followed by a systematic, risk-based safety assessment approach used for comparing known safety concern thresholds.
  • The important stages in the risk assessment process as demonstrated by case studies from typical drug manufacturing processes where single-use components were used.

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

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.

Dec. | 2014

• Presenter: Karen Green, Senior Product Manager, Mobius® Single-use Assemblies, Merck
• Abstract

  Biopharmaceutical companies are using single-use containers and assemblies for upstream and downstream processes at an ever increasing rate. Since process fluids come in contact with the inner film layer of these single-use containers, there is a need to understand the extractables profile at room and elevated temperatures and over prolonged time of exposure. This webinar will outline the study that determined the extractables profile of our new PureFlex™ Plus film and original PureFlex™ film. By attending this event, you will learn about the model stream approach used in the study and why we chose this approach instead of conducting actual formulations. We will present out the results of the extractables profile for the new PureFlex™ Plus film and answer any questions you may have about extractables and leachables as they relate to single-use technologies.

Sept. | 2014

• Presenter: Beth Goodrich, Manager, Worldwide Application Engineering, Merck
• Abstract

  The implementation of single-use technologies for pharmaceutical product development continues to gain momentum, is due to the advantages of increased flexibility, speed of implementation and lower capital investment. In particular they are seen as a means to accelerate the production of material for clinical trials. However, a primary concern regarding the use of such technologies is the impact and level of leachables in the final drug substance. This concern is typically addressed through a risk assessment utilizing extractable substances data based on model solvent extractions from individual components and devices. However, little if any data has been published where leachables are evaluated under actual process conditions through a complete single-use clinical scale process train. We have addressed this by completing a pilot scale 100L “mock” mAb production and purification where the cells, and hence mAb protein, are absent but where the bioreactor was run for the normal duration with cell culture media and feeds, and the DSP train utilized all the standard process devices, buffers, conditions and procedures. Data are presented on the leachables profile throughout the entire production process and, where relevant, a comparison made to the extractables data and risk assessment.

Sept. | 2013

• Presenter: Ross Acucena Regulatory Consultant, Merck
• Abstract

  Adoption of Single-use systems and components within pharmaceutical manufacturing processes is increasing. The motivations for implementing single-use technologies are numerous including reduced capital cost, reduced risk of contamination, smaller environmental footprint, and faster changeovers. Despite the many advantages of single-use technologies many drug manufacturers continue to view the assessment of extractable and leachable substances as a primary factor restricting their adoption of single-use technologies. This presentation will discuss the application of a systematic, risk-based rationale combining standard worst-case test methods with appropriately chosen analytics and known toxicological thresholds to investigate the impact of extractables and leachables in a pharmaceutical process. A practical and scientific treatment of the assessment of extractable and leachable substances will be demonstrated through case studies for a variety of single-use components and systems employed in various unit operations.