PepTalk 2017
PepTalk 2017
Archived Content

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Extractables and Leachables
Toxicological and Biochemical Challenges in Packaging and Delivery
January 24-25, 2013 


Day 1 | Day 2 | Download Pipeline 5 Brochure | Download Formulation and Packaging Flyer 

In biopharmaceutical drug development and manufacturing, containers, drug delivery devices/combination products (inhalers, pens, insulin pumps and implants), and even disposable equipment may release low molecular weight chemicals into the product and possibly compromise the biological safety and efficacy of the drug product. This conference covers how testing for extractables and leachables should be conducted, how to control extractables and leachables in drug product, how to comply with regulatory guidance, and how to ensure the quality of your product. 


1:00-2:00 pm Conference Registration


Regulatory Guidance for Biologics 

1:45 Chairperson’s Opening Remarks
Russell Jones, Life Sciences Global Marketing Manager, Entegris, Inc. 


1:50 Scientific and Regulatory Considerations for Extractables & Leachables in Therapeutic Biologics: A Risk-Based Approach

Ingrid MarkovicIngrid Markovic, Ph.D., Special Advisor to Associate Director, Review Management, Office of the Center Director, CBER, FDA

This presentation will provide an overview of a risk-based assessment and risk-mitigation strategy for Extractables & Leachables (E&L) identified in therapeutic biologics in order to minimize the risks to product quality, safety and efficacy. Recommended test methods for E&L analysis including identification of common sources will be discussed. Real-life case studies supporting recommended practices for E&L evaluation will be presented.

2:35 E&L Managemment for Injectable Drugs: Comparison of Final Package Components vs. Process Components

Edward J. Smith, Ph.D., Principal, Packaging Science Resources, LLC

Expectation of E&L studies by health authorities continues to grow.  Basic E&L requirements for final packaging and process components are the same but the risk assessment processes used to manage E&L studies are different.  This presentation will compare the key similarities and differences that will allow sponsors to comply with regulators’ needs.


Single-Use Systems 

3:05 Pharmaceutical Manufacturer’s Approach to Qualification of Single-Use System

Ken M. Wong, Senior Scientist, Specialty Analytical, Center for Extractables and Leachables, Merck & Co., Inc.

This presentation provides a review of our standardized qualification approach for qualification/validation of SUS into Merck sites. Risk assessment model was utilized to determine the required extractable and leachable study among other qualification studies.

Toxikon 3:35 Addressing Toxicology of Extractables & Leachables John Iannone, Program Manager, Toxikon CorporationA primary goal of Extractable & Leachable testing is to determine the toxicological concerns associated with the evaluated systems. As a leader in Extractable and Leachable testing, Toxikon has developed a unique solution to address these concerns in a streamlined manner: TOX-RITETM (TOXIKON’S RAPID INITIAL TOXICOLOGICAL EVALUATION).

3:50 Refreshment Break in the Exhibit Hall with Poster Viewing

Entegris4:30 Risk Mitigation Through Component Material Selection Including Extractable Data from Materials of Construction

Michael W. Johnson, Applications Engineer, Life Sciences, Entegris, Inc.With the continued growth of single-use bioprocessing systems comes increasing concerns associated with today's polymers. Through a more fundamental understanding and evaluation of polymer materials, it is possible to significantly reduce the potential for final product contamination. This presentation will discuss and compare key polymer material performance characteristics, as well as present extractable data from different classes of polymer materials used as wetted surfaces in single-use systems.

5:00 A Risk-Based Approach to an Extractables and Leachables Testing StrategyRonald Bates, Ph.D., Director, Purification Development and Stability, Allergan, Inc.As the industry increases the use of single-use equipment and vessels, a more stringent extractables and leachables strategy must be employed. This presentation will explore the use of a risk-based approach to develop a holistic extractables and leachables testing plan. 


5:30 Current Best Practices for Determination and Evaluation of Extractables and Leachables from Single-Use Bulk Packaging and Filling Systems

Jerold MartinJerold Martin, Ph.D., Senior Vice President, Global Scientific Affairs, Biopharmaceuticals, Pall Life Sciences; Chairman, Bio-Process Systems Alliance (PBSA)

Assessment of safety risk of chemical migrants from single-use packaging and filing systems (SUS) has been a primary concern for potential users.  To facilitate generation of appropriate data and risk assessment, the BioProcess Systems Alliance (BPSA) published a series of “Best Practice” guides for determination of extractables and leachables from SUS that have assisted suppliers and users in developing acceptable data for regulatory review and approval.  This talk will review the recommendations of the BPSA Extractables Guides and approaches to leachables safety risk assessment, as well as recent initiatives to further standardize extraction test conditions in supplier-generated extractables data packages.

6:00 End of Day

Day 1 | Day 2Download Pipeline 5 Brochure | Download Formulation and Packaging Flyer