New Extractables and Leachables Approach for Parenteral and Opthalmic Drug Products to be Discussed by Catalent Expert at Forthcoming Workshop
USP & PQRI Sponsored Event Will Examine New Standards and Recommendations
Somerset, NJ – December 9, 2013
— Thomas Feinberg, PhD, Catalent Pharma Solutions’ Director of Development and Analytical Solutions, is to present at the forthcoming “Suitability and Compatibility for Packaging and Delivery Systems: Extractables & Leachables Workshop”, which is co-sponsored by the US Pharmacopeial Convention (USP) and the Product Quality Research Institute (PQRI). The aim of the workshop, which takes place on the 9th and 10th December at the USP Meetings Center, Rockville, Maryland, is to present and discuss stakeholders’ feedback on new extractables and leachables standards and recommendations.
Dr. Feinberg’s presentation, “Bridging the Divide: Use of Simulation Studies to Resolve the Parenteral and Ophthalmic Drug Products (PODP) Analytical Challenge,” will be given at 3.25 pm on Tuesday 10th December, and will introduce the PQRI Extractables and Leachables Working Group’s concept of the “Simulation Study”. This type of study is designed to provide analytical assurance that potential leachables in PODPs do not impart unacceptable risk to patients. These studies are especially useful for dosage forms such as Large and Small Volume Parenterals, where the number of doses per container is low and the dose volume is high.
Dr. Feinberg has over 15 years’ Pharmaceutical Analysis experience and over 25 years of experience in Mass Spectrometry and Organic Spectroscopy. 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 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.
Catalent Pharma Solutions is the global leader in development solutions and advanced drug delivery technologies, providing world-wide clinical and commercial supply capabilities for drugs, biologics and consumer health products. With over 75 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable product supply. Catalent employs approximately 8,500 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and generates more than $1.7 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com .