HEK-293/T Cell Bank Testing
HEK-293/HEK-293T (human embryonic kidney) cell lines are frequently used in the biopharmaceutical industry to manufacture viral vectors supporting cell and gene therapy modalities. To support the clinical advancement of these new therapeutics, the HEK cells used for vector production must undergo a formal GMP cell banking program, including production of Master and Working Cell banks and the appropriate panel of GMP release testing.
The regulatory expectations and guidance for characterization testing of cell banks are outlined in various documents from the FDA, EMA, WHO, and ICH. Eurofins BioPharma Product Testing’s recommendations for cell line characterization, safety evaluation, and product testing for a HEK derived biopharmaceutical product are summarized in this document. It outlines a testing strategy that should satisfy the latest guidance of global regulatory authorities, including the FDA and EMA.
Like other cell lines, HEK cells are susceptible to a wide variety of contaminants, including microbial, fungal, mycoplasma, and viral adventitious agents (including species specific human viruses). Eurofins BioPharma Product Testing’s network of laboratories has validated the methods required to meet domestic and international regulatory requirements to release and characterize the cell banks used for viral vector manufacturing.
Why Choose Eurofins BioPharma Product Testing?
- We offer capabilities to prepare and characterize a wide variety of mammalian, insect, and avian cell banks, including master, working, research, bioassay, and ready-to-use cell banks.
- Our cGMP-compliant facilities include multiple Grade A/B suites with Animal Origin Free options and ISO 7 clean rooms with ISO 5 critical areas designed to meet current FDA/EMEA aseptic processing guidelines.
- We also offer a comprehensive package of safety testing services in the areas of microbiology, mycoplasma, genetic stability, viral safety, and biochemistry to support your cell banking needs. All of these services are provided with strict adherence to cGMP requirements and are designed to fully support biopharmaceutical products, including the testing of raw materials, cell lines, unprocessed bulk, purified bulk, and final product.
