Comprehensive Cell and Gene Therapy Testing Capabilities

Eurofins BioPharma Product Testing is experienced in evaluating critical quality attributes (CQAs) of a diverse range of ancillary and raw materials, including monographed and non-monographed materials, such as chemically defined growth media, process buffers, cytokines, growth factors, and enzymes using platform GMP methods as well as customized methods developed to fit unique client needs.

Our biopharmaceutical testing experience, dedicated teams of raw materials scientists, and state-of-the-art instrumentation allow us to quickly establish methods so routine samples can be tested and reported in a timely manner.

The Eurofins BioPharma Product Testing lab network offers 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, GMP non-production (reagent or bioassay) master and working cell banks and R&D cell banks as well as banking for end-of-production cells upon request. We perform all GMP production cell banking in our Grade A/B or ISO5/7 clean room suites in accordance with EMA and/or FDA requirements and prepare all other banks in clean cell-culture labs where no work with adventitious agents occurs. We also support characterisation of cell banks, including sterility, mycoplasma, adventitious and endogenous viruses, identity and genetic stability. Additional tests that may be needed include transgene expression and biochemical and cell-surface markers

The Eurofins BioPharma Product Testing lab network provides 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 titres, and replication-competent virus testing.

Eurofins BioPharma Product Testing offers a streamlined cGMP approach to lot release 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.

To meet the critical quality attributes of identity, potency, purity, safety, and stability it is common for ATMPs to have over 30 methods to test bulk and finished products for release to the clinic or market. Eurofins Biopharma Product Testing offers 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 or more location via method transfers to our global sites. We also offer stability storage as well as dedicated laboratories and staff for stability and release testing.

Multiple plasmids containing various components required for viral packaging and transgene delivery are often utilised for the production of Gene Therapy viral vectors. These 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.