CGMP Bioprocessing

CGMP Bioprocessing

Bioprocessing

Information

Wheeler Bio’s team of experts utilize cutting-edge technology and equipment to provide CGMP drug substance manufacturing with strict control standards and processes, ensuring consistent clinical drug substance supply. Leveraging our agile facility design and highly trained operational staff, we offer drug substance manufacturing services for antibody and antibody-like formats that fall within industry standard equipment and production parameters. Our highly experienced manufacturing team performs both non-GMP engineering drug substance production runs as well as full CGMP production runs at a 50L to 500L scale for pre-clinical and clinical supply. You can let Wheeler handle all your small-batch manufacturing needs, regardless of your clinical development stage.
Wheeler Bio832Wheeler Bio is a biomanufacturing pioneer founded by a team of industry experts and strategic investors who believe a different CDMO model is needed for innovators to bring new therapeutic leads to the clinic faster, without the risk and cost associated with traditional outsourcing models. Our novel hub-and-spoke concept, centered in Oklahoma City with satellite labs embedded in discovery centers on the coasts, will revolutionize the translational path from discovery to CMC development and first patient dosing. Wheeler’s pioneering, highly-accessible, open-source development platform – Portable CMC® – delivers speed to clinic and uniquely-affordable workflows by integrating discovery CROs and CDMOs. Portable CMC® is a suite-ready drug substance manufacturing platform that customers can transfer to any CDMO in the world with no royalties, licensing fees or penalties. By overlapping with the discovery workflow, Portable CMC® reduces timelines and regulatory risks through the introduction of QbD (Quality-by-Design) principles earlier on in the drug development life cycle, increasing the opportunity for clinical success.

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