Eurofins

Transmission Electron Microscopy’s key advantages is its unbiased nature, making it an ideal complement to in vitro assays and molecular techniques in determining the microbiological safety of biological products. The Eurofins Electron Microscopy laboratory can aid in evaluating the size, shape, and purity of viral particles, as well as assessing their capsid content.

Gene therapy products require extensive experience in bioassay development, optimization, phase appropriate method validation/transfer, as well as assay maintenance to support routine lot release and stability testing. Learn how Eurofins BioPharma Product Testing can support your gene therapy products.

Eurofins BioPharma Product Testing supports the development of cell and gene therapies by providing comprehensive GMP-compliant CMC testing support to ensure the identity, potency, purity, and safety of starting materials, intermediate products, vectors, and final drug products as well as support for manufacturing process development and validation.

Eurofins BioPharma Product Testing’s dedicated Biologics Raw Materials testing team has vast experience in cell and gene therapy manufacturing from early clinical, through process validation, product optimization, and marketed release. Work with the team that has over 20 years of biopharmaceutical experience for your raw materials program.

Mycobacterium has been a concern in the vaccine industry for many years and now for the gene therapy industry. At the speed the industry is moving, faster and alternative approaches are needed to address speed of results as well as quantity of material needed. The Eurofins Mycobacterium complex PCR detection method can issue a COA in 10 days, requiring only 1-2mL of sample.

Industry changes can often introduce additional risks to the sterile fill/finish process, resulting in production delays, additional costs, and safety concerns. Choose Eurofins BioPharma Product Testing to help eliminate 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. Learn how we can help increase speed and flexibility to drive your drug product into the clinic, and ultimately to patients faster.

Eurofins BioPharma Product Testing in San Diego can help you realize the golden potential of your investigational new drug, including formulation and fill/finish services.

Eurofins BioPharma Product Testing can help eliminate human error and other associated risks when producing small batches of sterile GMP product for Phase I-II trials using our state-of-the-art Vanrx Microcell Vial Filler.