GMP-Grade Cell Batch Testing
GMP Grade Cell Batch Testing
Need quality control (QC) testing for your potential cell or gene therapies? Applied StemCell offers GMP-grade cell batch testing. As a CDMO, we have well-established QC procedures. Leverage our QC capabilities and allow our team of experts to safely and efficiently conduct your safety testing. Contact us today to schedule your free consultation.
GMP-grade cell batch testing refers to a set of quality control tests that are performed on a batch of cells intended for use in human clinical trials or commercial production. GMP (Good Manufacturing Practice) is a set of guidelines and regulations that ensure the quality, safety, and efficacy of pharmaceutical products, including cell-based therapies.
GMP-grade cell batch testing involves a series of assays and tests to confirm the identity, purity, potency, and safety of the cells. These tests include tests for sterility, endotoxin levels, mycoplasma contamination, viability, and identity of the cells. In addition, potency assays are performed to confirm the desired biological activity of the cells.
GMP-grade cell batch testing is a critical step in the manufacturing process of cell-based therapies, as it ensures that each batch of cells is of consistent quality and meets the necessary standards for clinical use. GMP-grade cell batch testing is performed by qualified personnel in a GMP-compliant facility, and the results are documented in a batch record, which serves as a record of the testing and manufacturing process.
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