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The new PQRI-PDP Recommendations and Biologics: what is there to learn and what is the impact on the study design for an E/L study?

August 18, 2022

4:00 pm CEST

Barbara Deckers

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.



Dr. Sona Kovackova

Study Director Small Volume Parenteral applications, Nelson Labs Europe

Dr. Kovackova holds a PhD degree in Organic Chemistry from the University of Chemistry and Technology, Prague, Czech Republic. She started her career as a Scientist at the Rega Institute for Medical Research KU Leuven, Belgium and later worked in Quality Control of medicines at the Belgian Institute of Public Health. In 2017, Dr. Kovackova took the position of Study Director at Nelson Labs Europe. Sona currently specializes in Extractables & Leachables studies with a main focus on injectable applications.