Eurofins

Stay compliant with Annex 1 for early phase sterile fill finish processes. Discover how to implement robust contamination control strategies, integrate isolator technology, and conduct integrity testing to meet stringent European Union standards. The guide provides a comprehensive look at key elements such as PUPSIT, critical zone controls, and monitoring and training for aseptic processes.

Explore the complexities of gene and cell therapy development with our comprehensive guide to Chemistry, Manufacturing, and Controls (CMC) testing. Learn how our expertise ensures the safety, potency, and quality of advanced therapies, supporting your journey from product development through regulatory approval.

Raw Materials are the foundation of every biopharma product. Our ultimate guide highlights how our testing support can help you establish purity, identity, and quality standards, ensuring a smooth manufacturing process and adherence to regulatory requirements.

Elevate your viral screening with Eurofins BioPharma Product Testing’s qPCR- based assays. Our advanced testing goes beyond standard screenings to detect even dormant and hard-to-detect pathogens, ensuring comprehensive safety in every stage of the allogeneic therapy pipeline. Protect your products – and your patients- with industry-leading sensitivity and specificity.

Eurofins BioPharma Product Testing (EBPT) in the US is a leading entity in the analytical testing of Cell and Gene Therapy, with its involvement dating back to 2010 at the Eurofins BPT Lancaster, PA location. Over the past decade, EBPT has developed a comprehensive business strategy catering to the analytical industry's needs, covering Raw Materials, Cell Banks, Plasmids, Viral Vectors, Genetically Modified Cells, CAR-T drug products, and iPSCs. The company has actively supported the growth of Cell and Gene Therapy through strategic investments, including the adoption of innovative technologies like droplet digital PCR, Analytical Ultracentrifugation , and Transmission Electron Microscope testing. These investments also involve dedicated facilities at various locations across the US.

Helium has been the preferred carrier gas for gas chromatography (GC) testing, but its finite supply, environmental impact, and recent supply chain issues have prompted Eurofins Lancaster BioPharmaceutical Chemistry teams to actively seek alternatives and reduce helium usage in laboratories. Conservation efforts include evaluating gas chromatography methods, checking for helium leaks during audits, and avoiding idle periods between analytical runs. Nitrogen and hydrogen are explored as alternatives, with challenges noted. Eurofins is committed to developing strategies to conserve or eliminate helium usage, recognizing the importance of reducing reliance on this non-renewable resource in the industry.

Eurofins acknowledges the significance of Cell and Gene Therapies, particularly Autologous Cell Therapies , in the healthcare industry. Recognizing the urgency associated with short shelf-life products, Eurofins BioPharma Product Testing has developed a comprehensive set of services to address the need for swift and reliable testing. This suite of services positions Eurofins as a one-stop-shop for rapid and facility testing requirements. Clients can benefit from guaranteed short turnaround times while maintaining the highest quality standards for tests crucial in ensuring the safety of Cell and Gene Therapies for patient administration.

The FDA's Office of Combination Products recently finalized guidance emphasizing the critical role of human factors engineering (HFE) in the development of combination medical products. Eurofins Human Factors MD highlights the importance of a robust HFE program, stressing its necessity rather than being optional. The guidance recommends considering combination products as parts, conducting a separate Use-Related Risk Analysis, and identifying meaningful critical tasks. It provides clarity on participant training in HFE validation tests based on UI design requirements. The document encourages manufacturers to address unique attributes of combination products and recommends a pre-submission review of the HFE validation protocol with the FDA to mitigate risks in marketing submissions.

Container-Closure Integrity (CCI) is essential for ensuring the stability and safety of drug products over time. The USP recommends deterministic methods over older probabilistic ones like dye ingress, emphasizing the need to assess the significance of leakage in relation to product quality. Eurofins can assist in choosing and validating appropriate CCI testing methods tailored to specific product and closure system configurations, as there is no one-size-fits-all solution outlined in the USP.

In the drug development process, drugs undergo a rigorous journey from target identification to new chemical entity identification, involving the screening of tens of thousands to potentially hundreds of thousands of compounds. Preclinical pharmacology and toxicology play crucial roles in translating laboratory findings to clinical applications. Toxicology studies, conducted in accordance with Good Laboratory Practices , assess the impact of pharmaceuticals on biological tissues and living animals, mimicking anticipated human exposure routes. Eurofins BPT, based in Jacksonville, FL, supports both toxicology and clinical trial material (CTM) requirements by preparing scaled-down batches using formulations and processes akin to finished products. In San Diego, CA, Eurofins BPT employs a state-of-the-art fill-finish facility with a gloveless, robotic isolator for sterile CTM filling, ensuring optimal sterility through real-time data monitoring and minimizing contamination risks.

A panel of experts from bio/pharmaceutical companies discuss plasmids to establish specifications using a risk-based approach to manage supply, including the response to cell & gene therapy industry feedback, future outlook and re-evaluating plasmid risks.

The Eurofins BioPharma Product Testing (BPT) lab in Portage, MI, is expanding its capabilities in raw materials testing through collaboration with its Lancaster, PA, site. With a surge in demand for raw materials testing, BPT aims to enhance business continuity and deliver seamless services. This expansion aligns with Eurofins' commitment to meeting clients' testing demands efficiently and maintaining high-quality results.

Eurofins BioPharma Product Testing’s Biologics Raw Materials testing team has vast experience in cell & gene therapy testing, including evaluating critical quality attributes for ancillary and raw materials.

No bio/pharmaceutical product can be manufactured without first establishing the identity, purity and quality of its starting materials to ensure the product is suitable for its intended use. This guide covers all testing and considerations for raw materials supported at Eurofins BioPharma Product Testing.

Eurofins BioPharma Product Testing’s Biologics Raw Materials testing team has vast experience in cell & gene therapy testing, including evaluating critical quality attributes for ancillary and raw materials.

For all stages throughout the development, manufacturing and release of your biological product, Eurofins BioPharma Product Testing offers comprehensive, fully cGMP-compliant Viral Safety Services, including characterization of cell banks, unprocessed bulk testing, end of production cells, and raw materials testing.

Eurofins BioPharma Product Testing supports the development of cell & gene therapies by providing comprehensive GMP-compliant CMC testing support to ensure the identity, potency, purity, and safety.

A panel of experts from bio/pharmaceutical companies discuss plasmids to establish specifications using a risk-based approach to manage supply, including the response to cell & gene therapy industry feedback, future outlook and re-evaluating plasmid risks.

Eurofins BioPharma Product Testing highlights how it overcomes the challenges faced in sterile fill finish manufacturing in the bio/pharmaceutical industry at our San Diego, CA facility. With state-of-the-art facilities and a vial filler, Eurofins provides a solution for 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.

Eurofins BioPharma Product Testing offers a 5-day rapid mycoplasma test comparable in sensitivity and specificity to the 28-day compendial method.

Eurofins’ whitepaper discusses insourcing & outsourcing solutions to solve challenges with meeting drug development timelines and budgets with restricted headcounts.

Eurofins’ whitepaper discusses insourcing & outsourcing solutions to solve challenges with meeting drug development timelines and budgets with restricted headcounts.