For the product release of new drugs or biologics, several tests are required from regulatory guidelines to ensure their quality. Cell lines must be authenticated, gene sequences must be confirmed, the identity of the plasmids used should be verified, and raw materials, cell lines and final products should be checked for mycoplasma and viral contaminations. BaseClear Quality Solutions can help you perform these tests in compliance with your quality system. These services can be either ISO or GMP compliant. We can assist you in designing an optimal testing strategy for your production process.

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