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Cell Line Testing & Cell Bank Testing
Cell lines used to manufacture biological products are commonly maintained as a master cell bank (MCB) and working cell banks (WCBs). Cells from the MCB are expanded to form the working cell banks (WCBs) used for production. The MCB must be characterized and extensively tested for contaminants such as bacteria, fungi, and mycoplasmas. WCBs should be appropriately qualified by characterization and testing as outlined in ICH guidelines Q5D, such as identity testing of the WCB, or copy number determination in transgenic cell lines.
Combined with cell-line authentication, test items may be checked for Mycoplasma contamination of the master cell bank, the working cell bank, or the cell line used in research.
Microsynth can verify any DNA and RNA sequence by GMP-compliant Sanger sequencing, or Sanger sequencing for research use. RNA and DNA isolation, cDNA synthesis and PCR steps preceding the sequencing may be added depending on the customer’s needs. For viral or bacterial samples, an NGS approach may be applicable as well.
Copy Number Determination
Microsynth can design and validate assays to verify the transgene copy number present in the genome of the transformant, taking advantage of our digital PCR platform.