To ensure safe, effective and high-quality biopharmaceutical and vaccine products manufactured using bioprocessing single-use plastic systems (SUS), it is important to assess extractables/ leachables profiles. These studies can be challenging, however a stepwise strategy that meets regulatory expectations and enables robust data generation can help lower risks associated with these materials. The study design and Analytical Evaluation Threshold analysis (AET) values should follow recommendations from industry guideline documents such as those from BioPhorum Operations Group (BPOG), the PQRI for PODPs, CDER from FDA, EMA and USP, or as appropriate to the application and region of interest.

In this case study, our expert, Dr. Tino Otte, Head of Consulting at Intertek in Switzerland, describes how we assessed three single-use systems destined for a vaccine production line as part of a materials assessment program to support selection of lower risk components with a safer extractables profile.

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