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

Chand, Subhash; Kumar, Birendra; Prathap, Vivek Morris; Singh, Surinder; Mahajan, Richi V.

doi:10.18520/cs/v114/i12/2513-2518

Cited by 3 publications

(1 citation statement)

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“…The claimed MOA of Rituximab were CD20-mediated complement-dependent lysis (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). The potency assay approved by ( 3 ) Center for Drug Evaluation and Research (application number 761103Orig1s000) was a single assay for CDC using a CD20+ tumour cell line ( 4 ); the other mechanisms of action were not tested.…”

Section: Definitions Of “Potency”mentioning

confidence: 99%

Bringing function to the forefront of cell therapy: how do we demonstrate potency?

Lowdell

Weil

2023

Front. Immunol.

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Unlike conventional pharmaceuticals, biologics and Advanced Therapy Medicinal Products (ATMPs) are required to meet a standard of “potency” as part of the final release criteria at completion of manufacture. During early phase clinical trials, most regulatory agencies have been willing to accept very immature potency assays with an expectation that these will be improved, qualified and validated during the clinical development of the drug to Marketing Authorisation Application (MAA) or Biologics License Application (BLA) submission.This model of continuous development of potency assay in parallel with drug development has already led to at least two notable problem cases; namely Iovance and Mesoblast. Both companies completed successful phase III clinical trials but, in both cases, the initial BLA was rejected on the basis that their potency assay for drug product release was inadequate. Fortunately these issues appear to have been overcome in March of this year, with Mesoblast receiving acceptance of their BLA for Remestemcel and Iovance obtaining a rolling BLA approval for Lifileucel.

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Section: Definitions Of “Potency”mentioning

confidence: 99%