For years, the foundations of cancer treatment were surgery, chemotherapy, and radiation therapy. Over the last two decades, targeted therapies like imatinib (Gleevec®) and trastuzumab (Herceptin®) —drugs that target cancer cells by homing in on specific molecular changes seen primarily in those cells—have also cemented themselves as standard treatments for many cancers. GMP Cell-based Assays or Potency Assay Applications We apply phase-appropriate potency testing to wide array of biologic products including biosimilars , peptides, monoclonal antibodies , growth factors and cytokines and applications, such as biopharmaceutical stability testing and biologic drug product release testing .
Gene and cell therapy have significant potential in treating a variety of diseases - from cancer to genetic disorders. In vitro, T cells can be reprogrammed to identify specific antigenic targets on cancerous B cells in vivo. Gene therapy efficacy also depends on successful binding of transfer...Sep 15, 2020 · A high level of regulatory support, and appropriate documentation packets facilitates the progress of a new therapy towards commercial use. Cell and gene therapies are inherently patient-centric, and therefore might require some adjustment of suppliers to ensure they are fully supported. Regional manufacturing enhances the continuous supply of ...
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