Modality
Fc-Fusion Protein Development and Manufacturing
Development of Fc-fusion therapeutics through integrated, phase-appropriate development and manufacturing solutions designed to advance complex biologics efficiently toward the clinic and beyond
Fc-Fusion Protein Solutions
Wheeler Bio’s data-driven approach helps address the unique manufacturability and development challenges associated with fusion proteins including expression and stability considerations.
CMC for Fc-Fusion Proteins
Through its ModularCMC™ framework, 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.
Fc-fusion molecules present specific challenges related to expression, stability, aggregation, and product quality attributes. Wheeler Bio’s platform-driven development approach combines scalable CHO cell line development, hybrid mechanistic process modeling, and early analytical and formulation assessment to address these complexities while supporting manufacturability and long-term supply reliability
Expertise in Fc-fusion protein development
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.
Structural Assessment
Structural and biophysical assessment of Fc-domain fusion partner and how it may affect production and purificationProduct Quality
Specialized analytical development to characterize the specific product quality attributes (PQA) landscape of Fc-fusion proteinsFormulation
Formulation development tuned to the biophysical challenges of large, multi-domain proteinsRegulatory Aligned
Early assessment of regulatory considerations based upon proposed indication, mechanism of action, and route of administration
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Program Types
Fusion protein 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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Fc-Fusion Protein Manufacturing
Wheeler’s fusion protein 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