Analytical & Bioanalytical Sciences

At Biocon Biologics, advanced analytical and bioanalytical sciences play a critical role in developing high-quality biosimilars — from recombinant insulins to monoclonal antibodies and other protein therapeutics.

Given the complexity of biologics, we use cutting-edge techniques to rigorously characterize the structural, chemical, and functional attributes of our biosimilars. This ensures they meet global regulatory standards and demonstrate comparability in safety, efficacy, and clinical outcomes.

Our expert teams and state-of-the-art platforms enable deep analytical insights across development, approval, and lifecycle management — ensuring consistency, quality, and patient trust at every stage.

Establishing Biosimilarity

Our R&D strength in biosimilar and biologics development is focused on a strategic QbD driven approach orthogonal techniques and fingerprint similarity.

Functional & Physicochemical Characterization

A multitude of assays, across a spectrum of molecules, is used to assess product structures and undertake functional characterization. Orthogonal technologies and suitable analytical methods are applied to in-process and batch-release tests. We also use sensitive methods to assess pharmacokinetics and immunogenicity to ensure global standards of safety and efficacy.

Cell-based Assays
  • Potency Assays for insulins, peptides, MAb and MAb conjugates
  • Immunology-based functional assays including T cell proliferation assays
  • Tumor cell-immune cell-culture assays
Cell-based Assays
  • Development and validation using surface plasmon resonance, radioligand binding and flow cytometry
  • Proliferation and cytokine evaluation assays
Cell-based Assays
  • Development, qualification and valuation of PK and immunogenicity measures, using ELISA and ECL formats.
  • Cell-based potency assays for neutralizing antibody determination

Functional & Physicochemical Characterization

Analytical technologies are important to gain insights into the biological products’ structure, composition and properties.

Physicochemical characterization, for structural and compositional attributes


Functional characterization, for the product’s effectiveness (how the biological product binds to the target, and its biological outcome)

Attributes are measured using 40+ physicochemical and functional assays in our state-of-the-art analytical laboratories. Data generated through these complimentary analytical tools at various stages in the development cycle allows for deep and thorough understanding of our products. This in turn enables devising appropriate chemistry, manufacturing and control strategies to ensure consistency in the quality of the products manufactured at large scales. This comprehensive amalgamation of process and analytics is essential for product approvals.
Related Links

Clinical Development

The Clinical Development and Medical Affairs (CDMA) team at Biocon Biologics is pivotal to the success of our biosimilar strategy,...
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Regulatory Sciences

This division plays a critical role in supporting the successful development and global commercialization of biosimilars. The team’s active participation...
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