Earlier this year, the final recommendations of the Product Quality Research Institute (PQRI) were published for Parenteral Drug Products (PDP’s). Apart from the wealth of information and considerations on how to design extractable & leachable studies for parenteral drug products in general, it also contains a lot of valuable information on specific considerations for biological products. For biological products, not only the safety but also the quality of the product and related concerns about immunogenicity and leachables reactivity come into play. With this presentation, we will provide an overview on the recommendations that can be found in the PQRI-PDP document and how it could affect the design of an extractable & leachable study for the primary packaging of biologics.
