Release testing of biologics into the EU

By Mark Glass, Eurofins Lancaster Laboratories, Republic of Ireland

With the consolidation of global manufacturing and increased use of single-site manufacturing through Asia and the Americas, the importation of biological medicinal products is becoming a key supply chain route into the European Union.

Under Directive 2004/94/EC, commercial products must undergo complete retesting of the product specification before a qualified person can certify the batches and allow onward entry into the market place.

Biologic compounds are often temperature sensitive and have more complex analytical requirements within their product specification. Eurofins Pharma Products Testing Group supports all aspects of biologics products testing. With experience in temperature controlled sample shipping and QPs on-site at several locations, Eurofins has the infrastructure to support incoming product.

These methods must be validated and transferred with a technical agreement in place with the client. Often these methods originate at the site of manufacture and must be those included in the Marketing Authorisation Application (MAA). The testing facilities will also be listed in the MAA .

Having a broad base of the required capabilities means the timelines for transfer can be managed effectively to ensure readiness for the testing and release of the all important commercial batches.

Contact: GMP_EU@eurofins.com