Modality
Multispecifics Development and Manufacturing
Support for the development of complex bispecific and multispecific antibody therapeutics through integrated, phase-appropriate development and manufacturing solutions designed to accelerate programs from discovery to the clinic and beyond
Multispecific Solutions
Wheeler Bio’s data-driven approach helps address the unique manufacturability and development challenges associated with bispecific antibodies and other multispecifics, including expression, stability, and product quality considerations.
Multispecific Antibodies
Wheeler Bio’s High-Science, High-Touch approach enables informed decision-making that supports efficient development timelines and a strong regulatory foundation for complex multispecific therapeutics.
- End-to-end support: Cell line development through cGMP drug substance and drug product
- ModularCMC™ work packages with milestone-based stop points
- AI/ML-augmented process and clone selection
- Integrated Oklahoma City facility – U.S.-based manufacturing for continuity of supply
Expertise in bispecific/multispecific antibody manufacturing
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.
Expression Constructs
Constructs are treated as a molecular engineering decision, where chain stoichiometry, promoter architecture, and vector design govern correct assembly.Product Quality
Product quality attribute (PQA) surveillance calibrated to multispecific complexity in addition to productivity for stable CHO pool and clone selection.Experience Led
Common risks of misassembly, chain mismatch, product-related impurities define the downstream process and analytical characterization strategies for multispecifics.Modular for Reduced Risk
ModularCMC is particularly useful as a risk-managed path to IND/CTA for complex biologics formats such as bispecifics and other multispecifics.
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Program Types
Multispecific 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 multispecific 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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Multispecific Manufacturing
Wheeler’s multispecific molecule 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