Modality
Antibody Drug Conjugate Manufacturing
Antibody-focused development expertise helps derisk and accelerate ADC programs from discovery through cGMP manufacturing
ADCs Start with Antibody Expertise
Wheeler Bio supports the development of antibody-drug conjugates (ADCs) through deep expertise in the antibody component of ADC programs, with development strategies designed around downstream conjugation and manufacturability requirements.
ADCs Built on a Strong Foundation
Wheeler Bio’s phase-appropriate CMC approach emphasizes robust antibody cell lines, as well as process and analytical development to support the safety, purity, and quality expectations associated with conjugated therapeutics.
Analytical characterization of the unconjugated antibody is designed to establish a strong regulatory and comparability foundation prior to conjugation, helping reduce downstream development risk. Wheeler Bio also works seamlessly with external conjugation and payload partners, aligning antibody CMC and conjugation development strategies early in the program lifecycle to support efficient advancement through phases of cGMP manufacturing.
Expertise in antibody drug conjugates (ADCs)
Wheeler Bio provides a single development partner across cell line development, process development, analytical characterization, formulation, non-CGMP and cGMP drug substance manufacturing, and drug product manufacturing.
Antibody Design
Antibody component development is executed with ADC manufacturability as the design criteriaSafety Focused
Process development philosophy aligned with the safety, and purity demands of conjugated payloadsRegulatory Aligned
Rigorous analytical characterization of unconjugated antibody to support regulatory continuity through conjugationHigh Touch Management
Thorough alignment of the antibody CMC and conjugation CMC development roadmaps at program inception
Explore ModularCMC™
Program Types
ADC 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 Fusion Protein 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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ADC Manufacturing
Wheeler’s ADC 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