Services
GMP Services
Integrated cGMP Manufacturing
Learn more about what Wheeler Bio’s team can bring to your program.
Wheeler Bio excels in providing cGMP master cell banking (MCB) services, leveraging industry-leading technology and stringent quality control processes. Our expert team ensures the generation and testing of master cell banks with precision, generating a consistent cell bank that reliably transitions your program through the key stages of clinical development. Wheeler Bio can also serve as a working cell bank provider for products advancing to commercialization. Whether as a standalone service or part of the ModularCMC program, Wheeler generates GMP master cell banks (MCB) and working cell banks (WCB) through fully documented, controlled, and automated workflows that ensure reproducibility, traceability, and full chain-of-identity with documented cell lineage from cell banking through GMP manufacturing. Quality is demonstrated through ICH Q5D-compliant cell bank qualification and characterization, supported by integrated in-house QC testing and specialized viral safety testing conducted by qualified external laboratories.
Wheeler Bio provides cGMP drug substance manufacturing for monoclonal antibodies and antibody-based modalities at its modern facility in Oklahoma City. The site is equipped with advanced single-use bioprocessing systems and purpose-built manufacturing suites designed to support early and late-phase clinical development. The manufacturing team executes both non-GMP engineering runs and full cGMP production campaigns, enabling efficient transition from process development to clinical manufacturing. These capabilities support programs across the CMC lifecycle from preclinical material generation through IND-enabling clinical supply, to late-phase clinical manufacturing. Wheeler Bio’s integrated teams ensure robust process control, traceability, and reliable clinical drug substance supply, helping biotechnology partners advance antibody programs from development through first-in-human studies and beyond.