Tuesday, June 07, 2022 1:52:36 PM
Yes, of course Northwest Bio can submit a MAA using their current manual production method. Whether the MHRA would approve it, is debatable. The MHRA has approved DCVax-L for compassionate use based on the manual production method, but the GMP requirements for an investigational product are not the same GMP for a commercial product. I’m not sure if you saw another post I made about this:
The ASCO presentation confirmed that Advent is translating the manual processes to automated processes, and this major (type II) change requires a change management/comparability protocol, and process validation data which is normally submitted in the manufacturing module of the MAA/BLA, but yes, this data and analysis could be submitted subsequently in a post-approval supplement when it’s completed. Generally, the comparability/change management protocol is submitted to the regulators before the comparability testing begins for their approval/feedback, and it can be included in the MAA as a preemptive measure to assure regulators that additional manufacturing development studies are on-going and will be concluded prior to commercialization.
There’s a new accelerated pathway in the UK that seem particularly advantageous for Northwest Bio, since the complete manufacturing data won’t be available when the initial submission begins. The Rolling review pathway allows the applicant to submit the application in separate parts, and each module is assessed when submitted.
Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-process-validation-manufacture-biotechnology-derived-active-substances-data-be-provided_en.pdf
Questions and answers on post approval change management protocols
https://www.ema.europa.eu/en/documents/scientific-guideline/questions-answers-post-approval-change-management-protocols_en.pdf
Comparability considerations for Advanced Therapy Medicinal Products (ATMP)
https://www.ema.europa.eu/en/documents/other/questions-answers-comparability-considerations-advanced-therapy-medicinal-products-atmp_en.pdf
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