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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
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Assessing analytical comparability of biosimilars: GCSF as a case study.
Neh Nupur1, Sumit Kumar Singh1, Gunjan Narula1
1Department of Chemical Engineering, IIT Delhi, Hauz Khas, New Delhi 110016, India.
Summary
This study assessed five Granulocyte Colony Stimulating Factor (GCSF) biosimilars against the innovator drug Neupogen®. Results demonstrate strong analytical and biological comparability, confirming biosimilar equivalence.
Area of Science:
- Biopharmaceutical analysis
- Analytical chemistry
- Drug development
Background:
- The growing biosimilar market necessitates rigorous analytical comparability studies.
- Ensuring biosimilar safety and efficacy relies on demonstrating equivalence to innovator products.
- Critical Quality Attributes (CQAs) must be assessed using appropriate analytical tools.
Purpose of the Study:
- To evaluate the analytical and biological comparability of five Granulocyte Colony Stimulating Factor (GCSF) biosimilars to the innovator product, Neupogen®.
- To establish a robust analytical platform for biosimilar characterization.
- To identify and characterize any product variants in GCSF biosimilars.
Main Methods:
- Physicochemical analyses including peptide mapping with mass determination, circular dichroism (CD) spectroscopy, reverse phase chromatography (RPC), and size exclusion chromatography (SEC).
- Bioactivity assessment via in vitro cell proliferation assays to compare relative potency.
- Advanced techniques like RPC-FLD and ESI-MS for variant characterization.
Main Results:
- Extensive analytical data provide strong evidence of structural and biological similarity between the GCSF biosimilars and Neupogen®.
- Most biosimilars were found comparable to the innovator drug.
- A conformational variant, initially presumed oxidized, was identified in three biosimilars through further investigation.
Conclusions:
- The analytical platform effectively demonstrated the comparability of GCSF biosimilars to the innovator product.
- The identified variant is likely conformational, not oxidative, requiring specific characterization.
- This study supports the development and approval of complex biosimilars through robust analytical assessment.
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