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Cambridge Healthtech Institute’s 3rd Annual
Extractables and Leachables
Protecting Quality of Biologics by Ensuring Safety and Compatibility
January 22-23, 2015


In biopharmaceutical development and manufacturing, containers, drug combination products and even disposable equipment may leach chemicals into the product, which can pose significant risks to product quality and potentially compromise the safety and efficacy of the biotherapeutics. The Third Annual Extractables and Leachables (E&L) conference will bring together industry experts and thought leaders to share their insights on latest trends and guidelines, how to design analytical testing strategies for E&L, case studies on identification and risk assessment E&L in drug product and best practices for identifying potential leachables and their impact on biologics.

We invite you to join colleagues from around the world in this discussion of the key challenges and solutions for E&L testing and see how experts are avoiding impurities to deliver a safe and stable product.

Preliminary Agenda 


E&L: UPDATES FROM INDUSTRY AND GOVERNMENT WORKING GROUPS

PQRI PODP Update

Daniel L. Norwood, M.S.P.H., Ph.D., Distinguished Research Fellow, Boehringer Ingelheim Pharmaceuticals, Inc.

Determining Suitability of Plastic Manufacturing Systems for Therapeutic Products: USP Standard Development

Desmond G. Hunt, Ph.D., Senior Scientific Liaison, U.S. Pharmacopeial Convention (USP)


RISK ASSESSMENT OF TOXICOLOGICAL AND BIOCHEMICAL CHALLENGES

Safety Evaluation of Extractables and Leachables for Parenteral Drug Products

Stephen A. Barat, Ph.D., Executive Director, Scientific Affairs – Pharmacology and Toxicology, Drug Development and Research, Forest Laboratories, Inc.

A Risk-Based Approach to Assess the Potential Impact of Extractables and Leachables Impurities from Single-Use Systems on the Safety and Quality of Biotechnology Products

Kim Li, Ph.D., DABT, MPH, Senior Manager, Product Stewardship Toxicology, Environment, Health, Safety & Sustainability, Amgen, Inc.


MATERIAL CHARACTERIZATION AND DEVELOPMENT OF A SUCCESSFUL ANALYTICAL STRATEGY

Biopharmaceutical Quality: Factoring Extractables into the Risk Equation

Diane Paskiet, Ph.D., Director of Scientific Affairs, West Pharmaceutical
Co- Developed by: Thomas Egert, Research Scientist, Boehringer Ingelheim GmbH & Co. KG

The Use of Kinetic Migration Models to Facilitate Extractables and Leachables Investigations

Dennis Jenke, Ph.D., Baxter Distinguished Scientist, Technology Resources, Baxter Healthcare Corp.

Important Considerations When Determining Filter Flush Volumes

Jennifer Juneau, Principal Scientist, BioTherapeutics Research and Development, Pfizer, Inc.


EXTRACTABLES AND LEACHABLES IN SINGLE-USE SYSTEMS AND QUALIFICATION CONSIDERATION

The Design and Data Interpretation of Extractable Studies of Polymeric Product Contact Materials in the Manufacturing of Biologics

Ping Wang, Ph.D., MBA, Principal Scientist, Pharmaceutical & Material Sciences, DPD, PDMS, Janssen Research & Development

Managing the Risks of Leachables from Single-Use Processing Equipment- A Practical Approach

Michael Ruberto, Ph.D., Material Needs Consulting, LLC

Qualification of Small SUS Components: Low Risk but Huge Challenge

Ken Wong, Deputy Director, MTech/AP&T - Extractables & Leachables, Sanofi Pasteur