Biosimilar Pathways: Optimized CMC Analytical Solutions for Seamless Comparability and Compliance
Posters
Information
Presented by:
Jessica Weaver, BioAgilytix Labs
Poster Number: P-308-Th
Poster Session:
The Weird and The Wonderful
Thursday, 25 Sept. at 15:45
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Controls (CMC) analytical strategy aligned with both FDA and/or EMA expectations. Robust comparability studies remain the cornerstone of approval, requiring orthogonal structural, functional, and stability testing to demonstrate high similarity to the reference product. Success hinges on a disciplined approach: must do activities include sourcing region-specific reference material, applying orthogonal characterization, and early regulatory engagement; to do activities include stress testing and risk-based justification of minor differences; while do not do pitfalls include over-reliance on single assays, assuming “similar” equals “identical,” or neglecting region-specific requirements.
Key topics:
1. Totality-of-evidence—anchored in orthogonal CMC testing—is essential for demonstrating biosimilar similarity.
2. Early regulatory engagement and risk-based justification of differences reduce uncertainty and accelerate development.
3. Leveraging a global CMC analytical CRO ensures scalable solutions, region-specific compliance, and efficient execution of comparability programs.
BioAgilytix, a global CMC analytical CRO, can support sponsors with these challenges by providing end-to-end analytical solutions, harmonized assay platforms, and regulatory-informed strategies that streamline comparability packages covering a combination of the assays listed below.
Assay (Parameter)
Primary Structure (Peptide Mapping, Intact Mass LC/MS)
Post Translational Modifications
Glycosylation Profile (LCMS or UPLC or CE)
Charge Variants (IEF, icIEF or IEX-HPLC)
Size Variants / Aggregates (SEC-HPLC, SEC-MALS, DLS)
Purity (CE-SDS, RP-HPLC, RP-UPLC, SEC-HPLC)
Process Related Impurities (HCP, HC DNA, Residuals)
Target Binding (ELISA, Flow Cytometry, SPR)
Cell-Based Potency Assays (Proliferations, Inhibition, Reporter Gene, ADCC,
