TEM Is the Ideal Complement to In-Vitro Assays and Molecular Techniques in Determining the Microbiological Safety of Biological Products

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.

Bioassays for Gene Therapy Products

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.

Your Ultimate Guide to Cell & Gene Therapy

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.

Raw Materials for Cell & Gene Therapy Manufacturing

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.

Detection of Mycobacterium Species in qPCR as a Consideration for Cell Banking Testing to Support Cell and Gene Therapy Manufacturing

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.

Choose Eurofins’ new state-of-the-art aseptic sterile fill/finish for clinical supplies

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.

Minimize Risks and Enhance Speed and Flexibility with Sterile Fill/Finish Support

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.

Westward Ho! See how Eurofins’ most western US BioPharma Product Testing site can accelerate your product development

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.

Sterile Fill/Finish Manufacturing

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.