Integrated CGMP Manufacturing
Wheeler Bio provides technology driven and reliable CGMP Master Cell Banking and Drug Substance Manufacturing services to round out our translational Portable CMC® services model. Our highly-skilled team ensures the precise generation and testing of master cell banks, guaranteeing consistency and traceability throughout the development process, as well as real-time monitoring of critical equipment and flexibility to adapt as programs progress toward clinical trials.
Additionally, we offer technically advanced and proven drug substance manufacturing capabilities at the 50L and 500L scale in our state-of-the-art clinical manufacturing facility in downtown Oklahoma City. Whether your program requires non-GMP engineering runs or full CGMP production runs, our highly trained team and dedication to quality, along with an advanced tech-stack ensures reliable clinical drug substance supply for antibody and antibody-like formats at any stage of development.
Learn more about what Wheeler Bio’s team can bring to your program.
Wheeler Bio excels in providing state-of-the-art CGMP master cell banking (MCB) services, leveraging cutting-edge technology and stringent quality control processes. Our expert team ensures the generation and testing of master cell banks with unwavering precision, guaranteeing a consistent cell bank that reliably transitions your program through the key stages of clinical development. Wheeler Bio can also be your working cell bank provider as you prepare for your journey to commercialize your product.
Whether as a standalone service or part of our Portable CMC® program, our MCB and WCB generation and characterization approach emphasizes traceability, reproducibility, automation, all with the highest quality equipment, including biosafety cabinets, CO2 incubator shakers, ultra-low control rate freezers, and automated filling systems. Quality control is further underpinned with QC testing adhering to ICH Q5D standards and protocols through our partnership with Charles River Laboratories and the RightSource℠ QC testing lab.
Wheeler Bio stands at the forefront of CGMP drug substance manufacturing, with a modern and innovative facility boasting a dedicated team of experts armed with the industry’s latest tech-stack and advanced single-use equipment for small batch CGMP drug substance manufacture. Our stringent control standards and processes guarantee a steadfast and reliable clinical drug substance supply for antibody and antibody-like formats with cutting-edge facility designs and highly skilled technical teams.
Our highly experienced manufacturing team is capable of performing both non-cGMP engineering drug substance production runs as well as full CGMP production runs at a 50L to 500L scale, catering to pre-clinical and clinical supply needs along the CMC development path. Whether you’re in the early phase of CMC pre-clinical development or preparing for clinical trial IND submission, Wheeler Bio’s comprehensive capabilities can be harnessed for small batch CGMP compliant drug substance production.