Biologics Release Testing

Analytical testing is essential in the development, manufacturing, and quality control of biopharmaceutical products to ensure their intended therapeutic effect. A comprehensive range of tests is required during release testing to evaluate concentration, identity, purity, impurities, physical properties, biosafety, and potency for products like new biologics and biosimilars.

At Eurofins Biopharma Product Testing, we combine scientific excellence with a deep understanding of regulatory requirements. Our GMP lot release testing covers monoclonal antibodies, therapeutic peptides/proteins, vaccines, oligonucleotides, gene therapy products and other biologics. We offer a comprehensive range of biopharmaceutical testing services, from analytical to microbiological testing, delivering precise and reliable solutions that support both biopharmaceutical development and commercialisation.

Under EU legislation, products manufactured outside the EU or in non-mutual recognition states must undergo release quality control testing by a GMP-certified EU lab before entering the market. Alongside testing, a European Qualified Person (QP) reviews the manufacturer’s quality documentation and systems to authorize product release and distribution in the EU. Clients looking to enter or expand in the EU market can rely on Eurofins' extensive release testing capabilities, method transfer expertise, experienced QPs, and auditing services. Additionally, through established partnerships, we assist with importation and distribution to wholesalers.

• Our team of scientists has extensive experience in analytical testing for biopharmaceutical products, providing clients with confidence in the integrity and reliability of their data. 
• We utilize state-of-the-art facilities and instrumentation to perform a wide range of analytical tests with precision and accuracy. 
• Our testing services strictly adhere to regulatory guidelines and industry standards, ensuring full compliance with FDA, EMA, and other regulatory authorities.
• We are committed to customer satisfaction, consistently exceeding expectations by providing high-quality testing services and exceptional client support.

CONTACT US