Cell Line Characterization and Product Testing for CHO-Derived Biopharmaceutical Products
Eurofins BioPharma Product Testing offers capabilities to prepare and characterize a wide variety of mammalian, insect and avian cell banks, including master, working, end of production and research banks. Our cGMP-compliant facilities include multiple Grade A/B suites and ISO 7 clean rooms with ISO 5 critical areas designed to meet current FDA aseptic processing guidelines.
We also offer a comprehensive package of safety testing in the areas of microbiology, mycoplasma, genetic stability, viral safety and biochemistry to support our cell banking capabilities. All of these services are provided with strict adherence to cGMP requirements and are designed to fully support the testing of your biopharmaceutical or biologic product, including the testing of raw materials, cell lines, unprocessed bulk, purified bulk and final product.
Eurofins BioPharma Product Testing provides recommendations for cell line characterization, safety evaluation and product testing for a CHO-derived biopharmaceutical product in the document below. It outlines a testing strategy that should satisfy the latest guidance of global regulatory authorities, including the FDA and EMA. However, it may not be necessary to conduct all of the tests listed. We highly recommend a discussion with our technical experts to evaluate those factors that can influence which tests can be omitted or whether additional testing might be required based on our experience.
The combination of our manufacturing capabilities with our extensive cell line characterization, cell line identification, cell line development and cell line production services provide you with a single-source solution for all of your cell line and product testing needs.
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