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Quality Assurance of Rituximab (Anti-CD 20) Antibodies by Potency Testing:Determining the System Suitability Criteria and Sample Acceptance Criteria


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, India
 

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.
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  • Quality Assurance of Rituximab (Anti-CD 20) Antibodies by Potency Testing:Determining the System Suitability Criteria and Sample Acceptance Criteria

Abstract Views: 455  |  PDF Views: 130

Authors

Subhash Chand
National Institute of Biologicals (Ministry of Health and Family Welfare), Government of India, Plot No. A-32, Sector-62, Institutional Area, Noida 201 309, India
Birendra Kumar
National Institute of Biologicals (Ministry of Health and Family Welfare), Government of India, Plot No. A-32, Sector-62, Institutional Area, Noida 201 309, India
Vivek Morris Prathap
National Institute of Biologicals (Ministry of Health and Family Welfare), Government of India, Plot No. A-32, Sector-62, Institutional Area, Noida 201 309, India
Surinder Singh
National Institute of Biologicals (Ministry of Health and Family Welfare), Government of India, Plot No. A-32, Sector-62, Institutional Area, Noida 201 309, India
Richi V. Mahajan
National Institute of Biologicals (Ministry of Health and Family Welfare), Government of India, Plot No. A-32, Sector-62, Institutional Area, Noida 201 309, India

Abstract


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.

References





DOI: https://doi.org/10.18520/cs%2Fv114%2Fi12%2F2513-2518