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The document provides analytical strategy options for the control of recombinant viral vectored vaccines to support COVID-19 vaccine developers.
The European Directorate for the Quality of Medicines and HealthCare (EDQM) announced on Nov. 3, 2020 the release of a document that discusses the control of viral vectored vaccines. The document was created in collaboration with the European Pharmacopoeia Group of Experts on vaccines for human use to support COVID-19 vaccine developers.
The document, titled “Recombinant Viral Vectored Vaccines for Human Use”, provides analytical strategy options for the control of recombinant viral vectored vaccines and includes recommendations on tests that can be used as an aid “in building appropriate analytical strategies,” EDQM stated in a press release. Topics covered in the document include substrate for recombinant viral vector propagation, recombinant viral vector seed lot propagation and harvest, purified harvest, final bulk, and final lot.