Diane Paskiet, Director of Scientific Affairs at West Pharmaceutical Services, will discuss regulatory and risk considerations for biologic drug safety during the Analytics and Impurities pipeline at PepTalk 2017 in San Diego.
In her presentation, Establishing Safety of Container Closure and Delivery Device Systems, Ms. Paskiet will explain how the safety of a biologic drug product can be affected by a combination of multiple interrelated factors. No single factor should be considered in isolation and one cannot be manipulated without affecting others. Compatibility and interactions must be considered from the outset of drug development, including raw materials, components, processing, packaging (primary and ancillary), and delivery systems. Evaluating these factors early on and throughout development can facilitate decisions at each step that will minimize risks to CQAs and safety.
A number of risks to biologic safety can arise from poorly characterized packaging materials, components, or systems, including particulate contamination, product aggregate formation, and presence of elemental impurities or other leachables. These risks can be assessed by fully understanding the chemistry and toxicology of packaging materials and evaluating component and system safety in simulation and actual conditions of use studies. The presentation will also provide an update on the Leachables and Extractables Working Group of the Product Quality Research Institute (PQRI), which is a non-profit consortium of organizations working to generate meaningful scientific information to ensure quality, safety, and performance of drug products.
Following the conference, Ms. Paskiet’s presentation will be available in the Knowledge Center of our website.
More information about PQRI can be found here.