Raw material testing
Testing of raw material plays a critical role in biologics manufacturing.
Raw material testing guarantees that starting material used in bioprocesses meets industry and regulatory standards set out for biopharmaceuticals.
Appropriate tests serve Quality Assurance purposes to ensure that materials meet stringent quality standards to manufacture safe and effective drugs for patients. In particular, the testing of raw material must cover the risk of bringing impurities, microbial contaminants, viral contaminants (adventitious agent testing) into the manufacturing bioprocess or the risk to give rise to default in stability or effectiveness of the drug product (potency assays to ensure consistency and reproducibility of manufacturing).
Early detection of unsuitable raw materials can prevent expensive downstream failures and production delays, thus saving costs for manufacturers.
Clean Cells brings 20+ years of experience to raw material testing for biologics and cell therapy products, building risk assessment tailored to raw and starting materials. This includes:
- Mycoplasma, sterility and endotoxin testing
- Viral safety testing (eg. trypsin and FBS testing)
- Leukopacs and donor cell testing for cell therapy products: derisking processes and safety testing for biological starting material.
- Potency testing (eg. functional testing of FBS, transfection efficacy of reagent)
Clean Cells partnered with major biopharmaceutical sponsors, thus building an expertise in raw material testing for various biologics and purposes. Our cGMP-certification and fully validated portfolio ensures the highest level of raw material testing at each step of development of manufacturing, thus ensuring high-quality biologics that positively impact patients’ lives worldwide.
For more information, please do not hesitate to contact us.
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