Eurofins BioPharma Product Testing

Articles

Compendia publications are periodically updated in order to align with industry trends and harmonize with global regulatory practices. Staying abreast of these changes well before they are implemented, and being ready to adapt as necessary, is in the best interest of any bio/pharmaceutical testing laboratory. Eurofins BioPharma Product Testing has proactively adjusted its procedures, collaborating with stakeholders and providing feedback to ensure smooth integration and minimal impact on existing testing methods.

Regulatory Spotlight - Compendia Updates: USP <621> and USP <1220>

Across our network of companies globally and regionally in North America, Eurofins has made a significant amount of progress related to our Environmental, Social and Governance initiatives. At Eurofins, we believe that sustainability is at the heart of what we do. We are guided by our vision to be the global leader in Testing for Life, our mission of contributing to a healthier and safer world, and our core values that provide a strong foundation towards Environmental, Social and Governance (ESG) initiatives.

Sustainability - at the heart of what we do

Eurofins BioPharma Product Testing offers comprehensive testing capabilities to ensure our clients’ drug products are supported throughout the development process to commercial release. Our Viral Clearance Services team provides fully cGMP-compliant services from research and development assessments through manufacturing, clinical trials, and filing for Biological License Application (BLA). Our staff is experienced with varied perspectives from the research, process development, and manufacturing sectors.

What to consider when planning a Viral Clearance Study

Eurofins BioPharma Product Testing acquired ENCO Pharmaceutical Development in the fall of 2022 after more than two decades of operation as an independent contract service provider. The acquisition expanded Eurofins BPT’s presence in the southeast United States and brought a significant amount of experience in three key areas: ophthalmic, medical device and animal health. Now renamed as Eurofins BioPharma Product Testing ENCO, we stand ready to serve in an even greater capacity, with expanded service offerings at both the former ENCO sites as well as connecting with added service.

ENCO expands EBPT's ophthalmic and medical device capabilities

Microbial challenge studies are non-compendial studies that evaluate the microbial growth potential of a product to determine safe holding time, storage conditions, and effectiveness of preservatives. These studies are often performed on sterile, non-preserved drug products that are prepared and/or penetrated for the purpose of final product preparation and are often held for a period of time before administration to the patient. 

The challenge to designing a Microbial Challenge Study

View a short podcast with Eurofins BioPharma Product Testing to learn how Eurofins overcomes the challenges faced in sterile fill finish manufacturing in the bio/pharmaceutical industry and solutions for producing small batches of sterile GMP or GLP products for use in Toxicology Studies, as well as Phase I or Phase II clinical trials by eliminating human error and other associated risks.