Wheeler Bio, a contract development and manufacturing organization (CDMO) for next-gen protein therapeutics, opened a state-of-the-art drug substance cGMP facility in Oklahoma City, OK.

The new 35,000 square-foot cGMP facility is comprised of two single-use drug substance lines (50L and 500L scale HyPerforma DynaDrive), warehousing, cold chain, a buffer and media prep suite, two master cell banking suites, a RightSource quality control testing lab (Charles River Labs), document control, utilities, and office space.

According to the company, the novel hub-and-spoke operational model (satellite preclinical material supply labs in metro areas with strong biotech clusters) is more accessible and more agile than larger CDMO service providers. The portable CMC platform encompasses state-of-the-art process development capabilities overseen by seasoned staff, along with the latest technologies enabling excellence in CGMP manufacturing.

“We are leveraging the cost advantages and the trained biomanufacturing workforce in Oklahoma City to create a highly differentiated CDMO,” said Jesse McCool, co-founder and CEO at Wheeler Bio. “With our accessible, modular approach to CMC development, extensive technology stack, and pools-based workflow parallelization, Wheeler is raising the bar for early-clinical-phase biologics services.”

“We are extremely pleased to be working in close collaboration with Wheeler and their portable CMC antibody process platform that helps facilitate the translation from preclinical discovery to clinical development,” said Julie Frearson, corporate senior vice president, chief scientific officer, Charles River. “It is very exciting to see the opening of their new CGMP facility, and the addition of a RightSource lab, operated by Charles River’s industry-leading experts, will support expedited QC testing needs both for Wheeler and their clients.”