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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.


 The Product Quality Research Institute (PQRI) and the Issue of Leachables and Extractables: Updates, Best Practices and Recommendations
Daniel L. Norwood, M.S.P.H., Ph.D., Distinguished Research Fellow, Analytical Development, Boehringer Ingelheim Pharmaceuticals, Inc. 

Day 1 | Day 2 | Download Brochure | Speaker Biographies 

 Final Agenda 


11:30 am Conference Registration

1:30 pm Ice Cream Break in the Exhibit Hall with Poster Viewing

E&L Guidance and Updates from Industry and Government Working Groups

2:00 Chairperson’s Opening Remarks

Diane Paskiet, Ph.D., Director, Scientific Affairs, West Pharmaceutical

Keynote Presentation

2:05 The Product Quality Research Institute (PQRI) and the Issue of Leachables and Extractables

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

The PQRI was created to facilitate interactions between regulatory authorities, academia and the pharmaceutical industry. In 2006, a PQRI working group published a recommendation document regarding leachables and extractables in Orally Inhaled and Nasal Drug Products which included safety thresholds for leachables. A second PQRI working group is creating a similar document for parenteral and ophthalmic drug products. This presentation summarizes the history and progress of PQRI related to leachables and extractables.

2:45 Determining Suitability of Plastic Manufacturing Systems for Therapeutic Products: USP Standard Development

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

Therapeutic products come into direct contact with plastic, glass and metal materials as the product is manufactured, stored and administered. Such contact may result in an interaction that may affect suitability for use (including its safety and efficacy) and therapeutic product may be adversely impacted by the interaction. The presentation will discuss USP’s effort to develop a new standard for plastic single-use manufacturing systems chapters, related to plastic materials characterization and extractables and leachable testing.

3:15 Initiatives by BPSA, ASME-BPE, ASTM Int’l and USP to Develop Standards and Standardized Approaches for Testing of Extractables from Single-Use Equipment

 Jerold_MartinJerold Martin, MSc, Chairman, Technology Committee, BPSA

Despite the multiple advantages of single-use systems, these polymeric assemblies also elicit concerns for their potential to contribute leachable compounds that could potentially impact production, quality or safety of finished drug products. This presentation will describe how suppliers are working with users in ongoing efforts to establish practical and scientifically-based standardized procedures for component extractables testing and data reporting among suppliers while meeting user needs and regulatory requirements.

3:45 “Organic Impurity Profiling” for Drug Products versus “Leachable Studies”:
What Is There to Learn?

Karen Pieters, Ir., Project Manager , Extractables/Leachables, Toxikon Corporation

Organic Impurities are critical quality attributes of drug substances and drug products because they have the potential to affect the safety and efficacy. The origin of the impurity may also determine which guidelines (and associated control limits) to follow in the final evaluation of the drug impurity. The scientific results of Leachable Studies, and in particular “screening” leachable studies, may assist in establishing a broad organic impurity profile for drug products, at low concentration levels.

4:15 Refreshment Break in the Exhibit Hall with Poster Viewing

Risk Assessment of Toxicological and Biochemical Challenges

5:00 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 LiKim Li, Ph.D., DABT, MPH, Senior Manager, Product Stewardship Toxicology, Environment, Health, Safety & Sustainability, Amgen, Inc.

Single-use systems (SUS) offer cost-effective new technologies for the manufacturing of biotechnology products. However, the extractables and leachables (E&L) impurities from the complex polymeric materials may pose risk to product quality and safety. The qualification of SUS presents challenges for regulators, pharmaceutical and device industries, as well as suppliers. This presentation proposes a risk-based strategy that integrates the understanding of materials science, process development, trace chemical analysis and toxicology assessments.

5:30 Biopharmaceutical Quality: Factoring Extractables into the Risk Equation

 Diane_PaskietDiane Paskiet, Ph.D., Director of Scientific Affairs, West Pharmaceutical

Co-Developed by: Thomas Egert, Research Scientist, Boehringer Ingelheim GmbH & Co. KG

Materials that contact biologics during manufacturing, storage and those associated with the final packaging configurations can pose risks to quality. The risk of substances leaching into drug products should be realized. This case study will illustrate relationships between the chemistry of a rubber material and mass transport properties via modeling to enable identification and mitigation of hazards. This knowledge can feed into design of relevant studies to reduce the uncertainty of leachables and contribute to justifications for material selection.

6:00-7:00 Reception at the Tiki Pavilion

Day 1 | Day 2 | Download Brochure | Speaker Biographies