Join us for a discussion on extractable and leachable considerations for biopharmaceutical manufacturing processes. We will discuss the use of polymeric/elastomeric materials or single-use systems that are commonly adapted by biopharmaceutical developers and manufacturers, including those in the cell and gene therapy space. Process equipment-related leachables (PERLs) can adulterate your drug substance or drug product and have become a recent focal point in E&L submissions/regulatory review. These compounds may be reactive, additive, or absorptive. They could have an impact on critical quality attributes including the safety, efficacy, and stability of your product. Following guidance from PQRI PDP, USP <665>, BPOG, BPSA, and Solvias will allow you to prepare for a regulatory request for this information or prevent a lengthy delay of approval.
Meet Our Guest Speakers
Christopher J. McGee, PhD and Christopher A. Latendresse, PhD
Team Leaders in Extractable/Leachable Chemistry at Solvias USA, LLC
Christopher J. McGee and Christopher A. Latendresse are the Team Leaders in Extractable/Leachable Chemistry (E&L), Chemistry, Manufacturing and Controls (CMC) and Quality Control Chemistry (QC) at Solvias USA, LLC in Canton, Massachusetts. Their team specializes in contract research and development in the field of small molecule services. The two scientists have combined to help hundreds of sponsors navigate the regulatory process for pharmaceutical approval over the past decade. Analytical Organic Chemists by training, Chris M. received his Ph.D. from Syracuse University and Chris L. received his Ph.D. from the University of Rhode Island. Together with their fellow chemists, they utilize many specialized chromatographic techniques in both liquid and gas chromatography and are actively building a new department of high-resolution accurate mass spectrometry (HRAM) at the Solvias facility located just outside of Boston (formerly Chemic Laboratories, Inc.).