Quality assurance of rituximab (anti-CD 20) antibodies by potency testing: determining the system suitability criteria and sample acceptance criteria

摘要

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 R-2 = 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.