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Genentech's Ocrevus Manufacturing Process Still A Work In Progress

 
• By Bowman Cox

Genentech overcame objections from US FDA quality reviewers to win approval of Ocrevus for multiple sclerosis by adding release and stability testing and committing to resolving process control issues, while suspending plans to accelerate post-approval manufacturing changes.

Unable to bring its Ocrevus (ocrelizumab) manufacturing process into a state of control before an accelerated review ended, Genentech Inc. overcame objections from the US FDA's quality reviewers with commitments to troubleshoot the breakthrough therapy's manufacturing process after approval.

Because differences between clinical and commercial versions of the drug substance and drug product showed a lack of control, the...

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More from Compliance

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