Eurofins BioPharma Product Testing

Learn about the importance of considering human factors testing beyond the initial validation phase. Through two case studies, it illustrates how seemingly minor product changes can trigger regulatory scrutiny. The message is clear: proactive testing and expert guidance are essential to navigate regulatory requirements effectively.

Raw material testing is critical for drug development, ensuring safety and efficacy. Look for a partner with extensive compendial experience, ample capacity, fast turnaround times, digital capabilities, modality expertise, global presence, regulatory compliance, and a focus on value.

EBPT Toronto expands Eurofins BioPharma Product Testing's North American presence, offering comprehensive product testing services in Toronto. With a focus on cGMP compliance, the facility provides chemistry, microbiology, and regulatory consulting services, including testing for controlled substances. It ensures consistent quality across its network, prioritizing customer satisfaction and regulatory compliance throughout the drug development process.

The Toxicology Team in Lancaster now offers expanded services including biological evaluations to help clients with biocompatibility strategies and regulatory compliance. We provide tailored consulting for specific needs like mitigating biological risks due to product changes or failed tests. Each project is evaluated individually, ensuring customized solutions and enhanced client value.

Eurofins BioPharma Product Testing in Lancaster, PA, is a leader in ensuring the quality and safety of cell banks used in biomanufacturing. Certified by regulatory agencies like the FDA and TGA, EBPT's Cell Banking Department operates under stringent quality standards. We employ controlled processes, including employee training and contamination control, to maintain quality. With global certification, EBPT's laboratories are equipped to meet manufacturing needs worldwide.

EBPT provides expert support for Environmental Monitoring programs, ensuring clean and controlled manufacturing environments. Our services include designing monitoring programs, collecting samples, and analyzing data using advanced equipment. With locations across the U.S., EBPT offers nationwide support to pharmaceutical and medical device clients with standardized practices and specialized expertise.

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.

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.

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.

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.

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.

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.

Join Eurofins BioPharma Product Testing and Vanrx (now part of Cytiva), for an in-depth discussion covering ways to eliminate human error and other associated risks when producing small batches of sterile GMP product for Phase 1 and 2 clinical trials.

Industry changes, such as shorter timelines and increased product complexity, can often introduce additional risks to the sterile fill/finish process, resulting in production delays, additional costs, and safety concerns.

Eurofins BioPharma Product Testing can help eliminate human error and other associated risks when producing small batches of sterile GMP product for Phase 1 and 2 trials using our state-of-the-art Vanrx Microcell Vial Filler at our San Diego, CA, laboratory. With flexible scheduling due to small batch sizes and streamlined batch records, we can help you ensure fast delivery to the patient. Learn More about Eurofins BioPharma Product Testing’s sterile fill/finish services.

From Starting Materials through Finished Product Testing, Eurofins BioPharma Product Testing’s 28 facilities in 16 countries deliver the most comprehensive scope of harmonized GMP testing services and seamless regulatory acceptance.