E13 – Leachables and Extractables

Leachables and Extractables Considerations for the Pharmaceutical Regulatory Environment

New Half-Day Course E13-33, Wednesday, November 20th, 8:30am – 12:00pm

 Dr. Thomas N. Feinberg, Catalent Pharma Solutions, Morrisville, NC

Historically, extractables and leachables investigations only considered the interplay between formulation and final packaging; but this narrow consideration has begun to evolve. Any contact between surfaces and excipients, intermediates or drug products can become a potential vector for introduction of leachables into final product and, hence, become a risk for patient safety. Prior to the Product Quality Institute’s seminal publication “Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products (OINDPs)” there was no agreement between regulatory bodies (FDA) and manufacturers on how to approach the question of patient safety with regards to extractables and leachables and how to categorize the resultant risk.

This course will present the current state of regulatory policy related to leachables and potential leachables (i.e., extractables) organized as to drug product type.  The course will also cover laboratory evaluation strategies for potential leachables (i.e., extractables), and safety evaluation of leachables within the context of an overall pharmaceutical development process with special emphasis on the sensitive nature of biologicals and other “high-risk” dosage forms.

Pharmaceutical product development, quality control and regulatory scientists.  Packaging and device manufacturers product development, quality control and regulatory scientists.

1.  Fundamental Definitions, Concepts and Guidances
2. Origins of Extractables and Leachables
     * Primary and secondary packaging
3. Regulatory “risk-based” assessments for leachables
     * Oral drug products
     * Inhalation drug products (OINDP)
     * Sterile drug products: Small molecule and Biologicals (large molecules)
4. Safety Evaluation of Leachables
     * The PQRI threshold concept
     * Leachables as immunomodulatory agents
     * Biologicals and compatibility
5. Future Technologies and Possible Trends in Leachables/ Extractables Analysis and Control
6. The Future of Regulatory Science Related to Leachables/Extractables

Dr. Thomas N. Feinberg is the Director of Structural Chemistry services for Catalent at the Research Triangle Park, North Carolina facility. Dr. Feinberg has over 15 years Pharmaceutical Analysis experience and over 25 years experience in Mass Spectrometry and Organic Spectroscopy. He has an undergraduate degree from Cornell University, obtained his doctorate in Physical Chemistry from the University of North Carolina at Chapel Hill and did post-doctoral research in environmental mass spectrometry at the UNC School of Public Health Department of Environmental Sciences and Engineering. Dr. Feinberg has led the Structural Chemistry Group at Magellan Laboratories through its acquisitions by Cardinal Health and subsequent purchase by the Blackstone Group as Catalent Pharma Solutions. He was a co-author on the PQRI Working Group on Leachables and Extractables recommendation “Safety Thresholds and Best Practices for Leachables and Extractables in Orally Inhaled and Nasal Drug Products (OINDPs).” After completion of that project, Dr. Feinberg helped develop and conducted many of the PQRI training modules both in the US and Europe. He has been an active member of the PQRI Leachables and Extractables Parenteral Ophthalmic Drug Product (PODP) working group from its inception in 2008. He has written and presented extensively on extractables and leachables issues and also on advanced analytical chemistry techniques for quantitation and characterization of pharmaceutical impurities, degradants and adulterants.