CMC Testing Support for Gene and Cell Therapy

With the promise to enhance treatment, greatly reduce side effects, and potentially cure many types of diseases and disorders, Advanced Therapy Medicinal Products (ATMP), such as gene and cell therapy products, 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 network of laboratories has supported the development of ATMPs both for traditional use as well as for use in personalized medicine for gene and cell therapy sponsors for over 10 years. 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.

Comprehensive Cell and Gene Therapy Testing Capabilities

Raw Materials

Eurofins BioPharma Product Testing network of laboratories is experienced in evaluating critical quality attributes (CQAs) of a diverse range of ancillary and raw materials, including monographed and non-monographed materials using platform GMP methods as well as customized methods developed to fit unique client needs.

Cell Banks

We offer expert capabilities for the preparation and characterization of a wide variety of mammalian and insect cell banks. We offer GMP production of master and working cell banks including the downstream GMP release and characterization of the cell banks.

Virus Banks

We provide extensive services for the characterization of your viral banks to ensure identity, potency, and safety prior to the use of these vectors in production. We support characterization of viral banks, including sterility, mycoplasma, adventitious viruses, identity, infectious and genomic titers, and replication-competent virus testing.

Plasmid Vectors

Plasmids are considered as critical ancillary materials and must go through a rigorous testing program to ensure the efficiency of manufacturing process as well as the safety and potency of the drug substance. Plasmids produced in bacteria should be tested for sterility and endotoxin as well as properties such as concentration, purity, identity, and integrity.

Viral Vector Harvest

Eurofins BioPharma Product Testing offers a streamlined cGMP approach to viral vector harvest testing. Our experienced team will help you ensure product purity and safety in order to move your product into downstream purification faster and with less risk of contamination.

As part of our Harvest Testing package, we offer tests, including bioburden, mycoplasma testing (compendial and rapid), in vitro viral screening, and virus specific qPCR assays. Additional tests include infectious titer or tests for the presence of replication-competent viruses.

Bulk and Finished Products

We offer the most comprehensive cGMP method establishment, characterization, ICH method validation, release and stability testing of any contract testing laboratory. We have developed and validated numerous assays to evaluate products and impurities, such as product and process residuals, in a wide variety of methodologies, including bioassay, ELISA, qPCR, chromatography and MS applications. For most products, we have the ability to establish all methods and execute all tests at one location. We also offer 110,000 cubic feet of stability storage as well as dedicated laboratories and staff for stability and release testing.

Cell Therapy

We provide full GMP testing support for allogeneic and autologous cell therapies.  We can support the traditional/compendial based testing for allogeneic products that are stable when frozen down and also support the progressive newer testing methodologies for rapid release testing for autologous products with a limited shelf life.

Learn more about Eurofins BioPharma Product Testing’s CMC testing support for Cell and Gene therapies.