Genentech committed to resolving these eight quality-related issues after it begins marketing Ocrevus:

Perform a shipping study that includes testing before and after shipping for eight quality-related factors.
Confirm validation of the ADCC assay for suitability in testing potency for release of the drug substance.
Confirm validation of the capillary electrophoresis glycan analysis assay for suitability in assessing levels of high-mannose 5 glycan for release of the drug substance.
Confirm validation of the reversed-phase ultra-high-performance liquid chromatography assay for suitability in assessing levels of Fc oxidation for drug substance release.
Confirm validation of the polysorbate 20 assay – or come up with an alternative assay – for suitability in releasing drug product and in detecting degradation during its storage.
Develop new primary and secondary reference standards that represent pivotal clinical study materials using a qualification protocol that's submitted for FDA approval as a supplement to the biologics license application.
Perform a leachables study that evaluates performance of the drug product container closure system throughout the shelf-life period. FDA said the firm committed to providing a toxicological assessment of all identified leachables.
Confirm that the updated manufacturing process yields a drug substance that's consistent with the clinical version in terms of critical product quality attributes.

Genentech's Ocrevus Manufacturing Process Still A Work In Progress

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