Batch release testing in accordance with specifications

Within the European Union (EU), there is a regulatory requirement that each batch of a finished marketed product be tested in the EU against the approved product specification. You need a partner that can provide you with a turnaround that shortens the time from product manufacture to availability to the patient.

With quality control laboratories on site that provide molecular biology, chemical and microbiological support we offer:

• A wide range of analytical resources including:
  • ELISA
  • Western Blot
  • Residual DNA
  • BCA testing
  • SDS-PAGE Analysis
  • RP-HPLC
  • SEC-HPLC (Aggregation)
  • IEX-HPLC
  • Sterility and endotoxin
  • Colorimetric Assays
• Complete compendial analysis (BP, EP, JP and USP)
• Experience and expertise in Batch Release testing of products manufactured outside the EU.
• IMP batch release and re-test
• Method transfer and analyst exchange
• FDA and MHRA audited laboratories

As an approved and accredited laboratory with a long history of batch release testing, we provide a wealth of experience across a wide range of product types.

For further information on our Global service offering please email pharmaservices@gen-probe.com