Drug Formulation Services

Drug Formulation Services

Formulation

Information

Wheeler Bio’s team of experts has decades of combined experience in the development of biopharmaceutical drug formulations. Leveraging cutting-edge equipment and technology at our Oklahoma City Integrated Process Development Lab, our formulation development services ensure a safe, reliable, and stable bulk liquid formulation that will serve as the basis for your drug product as you progress your program from discovery to clinical trials and beyond. Our innovative formulation development strategy is designed with tight timelines and budgets in mind. Through the use of machine-learning based models and Design of Experiments (DoE) techniques, the Wheeler formulation development team is able to quickly determine the ideal drug product formulation for your drug substance and provide the appropriate stability screening results in a matter of weeks. This process ensures all stability requirements fall in accordance with ICH guidelines, avoiding potential bottlenecks as your program progresses to clinic. This service is also offered along with a full manufacturability assessment as part of our Portable CMC™ offering. Wheeler utilizes cutting-edge equipment and software in our Oklahoma City Process Development Lab to ensure safety and stability, including: • Uncle® (Unchained Labs) biologics stability screening platform • Life Sciences R&D Cloud (Synthace) • Maurice (ProteinSimple) • m-VROC Viscometer (RheoSense) • Process Data Analytics Software (DataHow)
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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