Cell & Gene Therapies

With the promise to enhance treatment, greatly reduce side effects, and potentially cure many types of diseases and disorders, these therapies are in high demand, and biopharma companies are in a race to the clinic. However, these technologies are very complex in nature and are vastly different than traditional biopharmaceutical products, especially when it comes to the use of these products for personalized medicine. The complexities span the development pipeline, creating challenges for manufacturing, testing requirements, regulatory approval, and commercialization.

Eurofins BioPharma Product Testing Ireland supports the development of ATMPs both for traditional use as well as for use in personalised medicine. We provide 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.

• We offer comprehensive cell and molecular biology, biochemistry, biosafety, and microbiology testing through one testing partner.
• We have provided cGMP-compliant testing support to gene and cell therapy sponsors for over 10 years and also support most contract manufacturers focused on ATMPs.
• We have vast experience in supporting cell and gene therapy manufacturing from early clinical, through process validation, product optimization, and marketed release.
• We have the laboratory capacity, BSL2 facilities, and state-of-the-art instrumentation to meet regulatory requirements and turnaround times for cell and gene therapy products.
• Our specialized sample delivery and receipt process ensures seamless communication between our lab and yours and expedites your samples into our laboratory.
• Our secure 24/7 online data portal, LabAccess.com, provides timely access to your test results.
• Our experienced project management and technical teams serve as your single-source solution for all of your testing needs.

• Gene Therapies – Viral Vector, Nanoparticle Vector, Plasmid Based, iRNA/mRNA
• Cell Therapies – Autologous, Allogeneic, Xenogeneic
• Viral Vaccines/Oncolytic Viral Therapies
• Oncolytic Peptide Vaccines

To learn more about our comprehensive cell and gene therapy testing capabilities, CLICK HERE

• Raw Materials
• Cell Banks
• Virus Banks
• Plasmid Vectors
• Harvest (Lot Release Testing)
• Bulk and Finished Products