Pharmaceutical NEWS - Spring 2010

EU Biologics Release Testing supported at Lancaster Laboratories’ site in Ireland

Bringing a biological product through development and to the market requires a tremendous amount of time, money and effort. Therefore, biopharmaceutical companies must market their products to as broad a geographical area as possible to get the most return on their investment. One challenge they face is the European Union’s (EU) legislation which requires that every batch of a marketed medicinal product be tested on European soil.

There are 27 member states in the EU and three other associated European Economic Area (EEA) states. Legislation passed at the EU level applies to these countries and is administered by the European Medicines Agency (EMA) for pharmaceutical products. Directive 2004/27/ EC replaces the text of previous legislation to read:

In the case of medicinal products coming from third countries, irrespective of whether the product has been manufactured in the Community, that each production batch has undergone in a Member State a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of the medicinal products in accordance with the requirements of the marketing authorization.

Therefore, release testing - the quality control testing of each batch of finished product - must be performed in the EU. Many biopharma companies do not have testing facilities in the region. Consequently, marketing of their products in the EU will require outsourcing of the batch release testing to an EU-based facility. EU legislation does allow the batch testing to be contracted out to third parties. Those methods and specifications for release testing listed in the marketing authorization application (MAA) will need to be transferred to the contract laboratory. The table to the right indicates typical batch release tests.

Batch release testing for the European market can be supported at Lancaster Labs’ location in Dungarvan, County Waterford, Ireland.

Facilities and equipment in the lab include:

• Cell Culture Laboratories
• Class C constructed cell culture suite and airlock room
• Class II Biological Safety Cabinets
• Multifunctional M5e Microplate reader, Part 11 compliance
• Cryogenic storage facilities
• Residual DNA suite
• Class C constructed laboratories with airlock corridor
• Applied Biosystems 7500 RTPCR, Part 11 compliance
• Class II Biological Safety Cabinets
• Protein and Molecular Biology Laboratory
• Alpha Innotech Gel Imaging System
• SDS-PAGE/IEF/Western blot equipment
• Best 2000 Biokit automated ELISA system

With Lancaster Labs’ sister facilities in Fisher Clinical Services and Fisher BioServices providing GMP importation and storage, Lancaster Labs has an impressive infrastructure to support biologics import testing. The European laboratory site often works in conjunction with the US laboratory facility to transfer methods post characterization and method development to provide seamless supply chain support into the European Union. Many clients are transferring methods between facilities as their investigational and commercial supply chains expand.