BioStem Life Sciences has extensive experience in manufacturing a wide range of biologics for human clinical trials, including plasmid DNA, cell therapeutics, viral vectors, vaccines, and recombinant proteins. BioStem has segregated manufacturing areas and platform manufacturing processes to support clinical production of several classes of biotherapeutics. All clinical production projects are performed following current Good Manufacturing Practice (cGMP) guidelines for early-stage clinical trials with comprehensive documentation of all manufacturing operations and quality control testing. BioStem provides QA audited batch records to support your Investigational New Drug (IND) filing, including chemistry and manufacturing.
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