Orthogonal Analysis Using Ligand Binding Kinetics & Live Cell Binding White Paper | Sartorius

Biosimilars - Orthogonal Analysis White Paper

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White Paper: Facilitating Analytical Characterization of Biosimilars During Development: Orthogonal Analysis Using Ligand Binding Kinetics & Live Cell Binding

Authors: Kirsty McBain, Daryl Cole, Stuart Knowling, Nicola Bevan, and David Apiyo

Last updated: May 2024

Overview

Biosimilars are biological medicines that are designed to be highly similar in structure and function to an already approved reference medicinal product (RMP). However, due to the inherent complexity of producing a biologically active copy of a protein, comprehensive comparability studies are required. These include critical quality attribute (CQA) assessments and the use of orthogonal techniques to reinforce confidence in biosimilarity.

In this whitepaper, we outline an analytical characterization approach for comparing prospective biosimilars with their RMP while emphasizing the use of complimentary orthogonal techniques; a biosensor-based ligand binding platform using the Octet® Biolayer Interferometry (BLI) Platform and a cell-based analysis using the iQue® 3 High-Throughput Cytometry Platform.


  • Document type: White Paper
  • Page count: 13
  • Read time: 22 minutes


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Key Takeaways

  • Growing Market: The biosimilars market is expected to exceed $100 billion by 2028, driven by the expiration of patents for original biologics and the need for cost-effective therapeutic options.
  • Regulatory Rigor: Stay informed about the latest industry trends and regulatory guidance from agencies like the FDA, EMA, & WHO mandate comprehensive comparability studies and evaluations of quality attributes for biosimilar approval.
  • Analytical Characterization: A combination of orthogonal and complementary analytical methods is essential for the characterization of biosimilars, including biosensor-based assays and live cell analysis.
  • Kinetic Analysis: Determining the binding affinity and rate constants of biosimilar interactions is vital for understanding their behavior and potential efficacy.
  • Comprehensive Approach: A thorough approach that includes both biosensor-based kinetic characterization and live cell binding assays is necessary for a robust comparison of biosimilars with their reference products, ensuring biosimilarity and therapeutic equivalence.

Figure 1. Cover of white paper.
 

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