Extraneous agents CRO Vaccine development Bioveterinary Research

Extraneous agents and potency testing

Wageningen Bioveterinary Research (WBVR) provides services to test products (vaccine batches) on extraneous agents, both of chemical and microbiological nature. We provide this service according to the requested regulations.

In accordance to strict regulations

In human and veterinary medicine there are strict regulations on the requirements of batch control of vaccines dictated by the European Pharmacopoeia and the European Medicines Evaluation Agency.

Extraneous agents

Since the production method for vaccines often requires raw materials like eukaryotic cells, bacteria or yeasts to produce the end product, there is a high risk of contamination with micro-organisms or chemicals. WBVR performs services according to the Good Manufacturing Practice (GMP) guidelines.

Besides that, we can facilitate testing of deep sequencing methods for extraneous agents testing. These results can be compared to proven technologies following the European Pharmacopoeia. WBVR also offers vaccine potency testing to confirm vaccine efficacy.

Potency and batch release tests

Animal models are used according to the customer’s needs, and scientific interpretation and presentation of results are included. Batch release tests on vaccine products are offered for veterinary (EP 0062) and human (EP 0153) use for release within the European Union, North America and Oceania.

Contact our expert

Please feel free to contact the expert of our Contract Research Organization (CRO) if you have a question concerning extraneous agents and potency testing.