A biomanufacturing firm Wheeler Bio has launched a drug substance current good manufacturing practices (CGMP) facility in Oklahoma City, US.
The 35,000ft2 facility, located inside the Ziggurat building, includes a cold chain, a warehousing, two single-use drug substance lines (50L and 500L scale HyPerforma DynaDrive), a buffer and media prep suite.
It also comprises a RightSource quality control testing lab (Charles River Labs), document control, two master cell banking suites, utilities, and office space.
Along with a new hub-and-spoke operational model (satellite preclinical material supply labs in metro areas with strong biotech clusters), the company claimed that it is more accessible and agile compared with larger CDMO service providers.
Wheeler Bio co-founder and CEO Jesse McCool said: “We are leveraging the cost advantages and the trained biomanufacturing workforce in Oklahoma City to create a highly differentiated CDMO.
“With our accessible, modular approach to CMC development, extensive technology stack, and pools-based workflow parallelisation, Wheeler is raising the bar for early-clinical-phase biologics services.”
The company said it has recently completed two commissioning runs using its Portable CMC antibody process platform and received first client orders for CGMP drug substance batches.
Production at the facility is expected to begin in the next month.
Charles River chief scientific officer and corporate senior vice president professor Julie Frearson said: “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.
“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.”