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Mahajan, Richi V.
- Quality Assurance of Rituximab (Anti-CD 20) Antibodies by Potency Testing:Determining the System Suitability Criteria and Sample Acceptance Criteria
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Authors
Affiliations
1 National Institute of Biologicals (Ministry of Health and Family Welfare), Government of India, Plot No. A-32, Sector-62, Institutional Area, Noida 201 309, IN
1 National Institute of Biologicals (Ministry of Health and Family Welfare), Government of India, Plot No. A-32, Sector-62, Institutional Area, Noida 201 309, IN
Source
Current Science, Vol 114, No 12 (2018), Pagination: 2513-2518Abstract
A validated and robust bioassay is of paramount importance in the various stages of biosimilar development to ensure efficacy, quality and potency. The complement-dependent cytotoxicity assay was validated over six simulated potencies and found specific for rituximab-like antibodies. The bioassay was found robust with linearity parameter R2 = 0.99, %GCV for precision and accuracy was less than 20% for >40 individual performances. Detailed set of system suitability and sample acceptance criteria was determined. The study may play a key part in the development of written and physical potency reference standards for incorporation in different pharmacopeia for effective biosimilar development and regulation.Keywords
Complement-Dependent Cytotoxicity, Geometric Coefficient of Variation, Quality Assurance, Rituximab.Full Text
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