Modality
Monoclonal Antibody Development & Manufacturing
End-to-end CDMO support for mAb programs from lead optimization through cGMP manufacturing
Expert mAb Solutions
Antibody-based therapeutics are the leading biologic modalities and Wheeler Bio’s CMC framework sits on a deep data set from processes purpose-built around them.
Purpose-Built CMC
Wheeler Bio brings deep expertise in monoclonal antibody (mAb) development and manufacturing providing integrated IND/CTA-enabling services from sequence to submission.
Through its ModularCMC™ framework, Wheeler Bio serves as a single, accountable CMC partner across cell line development, process development, analytical development, formulation, non cGMP and cGMP drug substance manufacturing, and drug product manufacturing.
Scaling monoclonal antibodies (mAbs) at Wheeler Bio is a data-tested and platform-driven process with built in checkpoints to assess manufacturing readiness and scalability with phase-appropriate investment. ModularCMC derisks timelines and enables efficient advancement of monoclonal antibodies to the clinic and beyond.
Expertise in monoclonal antibody (mAb) development
mAb programs carry a defined set of CMC risks, and Wheeler’s process development and analytical teams build programs around them from the start.
IND/CTA-Enabling
A single, accountable development partner across cell line development, process development, analytical development, formulation, and cGMP Drug Substance manufacturing.Cell Line Development
Exploiting semi-targeted genomic integration to generate scalable, high producing stable CHO pools and derived clones.Platform-driven
Development engine anchored in hybrid-mechanistic process modeling, where manufacturability fit informs process investment, clone selection stringency, and timeline.Characterization
Analytical toolbox built as a defensible regulatory narrative with formulation and stability are evaluated early in a product’s development lifecycle.
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Program Types
mAb programs at Wheeler typically run through ModularCMC™, where work packages combine into milestone-driven configurations. Wheeler builds biologics programs by combining work packages to match your development scope.
Data-Driven Milestones for mAb Programs
Each configuration is built from defined work packages so partners can right-size scope and pause for data review at each milestone before committing to the next phase of investment.
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mAbs Manufacturing
Wheeler’s mAb programs continue seamlessly from development into cGMP manufacturing, drawing on the same team, facility, and analytical methods that defined the process.
Master Cell Banking
The foundation of every cGMP lot.
Drug Substance Manufacturing
Scalable upstream and downstream production.