Services
cGMP Drug Substance Manufacturing
cGMP Drug Substance Manufacturing Services
Wheeler Bio provides cGMP drug substance manufacturing services for clinical-stage biologics programs, supporting monoclonal antibodies and antibody-based modalities. Our facility is designed for flexible clinical-scale cGMP manufacturing, enabling reliable production of clinical drug substance for early development programs.
Manufacturing operations utilize single-use bioprocessing systems and controlled cGMP procedures to support both non-GMP engineering runs and full cGMP manufacturing campaigns.
Wheeler Bio supports programs from preclinical through clinical development, with manufacturing campaigns capable of producing kilogram-scale quantities of drug substance to support clients from early discovery through late-phase clinical development.
Learn more about Wheeler Bio’s cGMP manufacturing services.
Multi-Modal Drug Substance Manufacturing
Wheeler’s manufacturing capabilities can be utilized for both non-cGMP engineering runs for preclinical material supply and for cGMP-compliant drug substance production for programs in preclinical or clinical stages. Wheeler Bio executes drug substance manufacturing batches as a module in the Modular CMC offerings (Work Package 7), or as a stand-alone service for processes transferred from our clients. As part of the Wheeler Bio ModularCMC® Lead to Clinic offering or for processes transferred from our client, Wheeler’s manufacturing team can quickly produce an IND/CTA-enabling drug substance or resupply DS for additional clinical development.
A Full Suite of cGMP Manufacturing Services
Wheeler Bio’s modern and innovative facility features two process trains, each with ballroom suites for maximum flexibility, and utilizes single-use technologies to mitigate risk and maximize throughput for antibody and antibody-like drug substance manufacturing. In addition, Quality Control laboratories are located within the same cGMP DS manufacturing facility, on their own level. Environmental monitoring (EM), microbiological assays, and a suite of analytical equipment and methods for cGMP characterization and release of both drug substance and drug product, as well as stability characterization of DS/DP. The Quality Control group possesses the ability to qualify, transfer-in, or validate analytical test methods.