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Wednesday, May 31, 2023 8:47:26 PM
Thanks for your thoughts about commercial manufacturing. There has been some great news and discussion recently about manufacturing this cell-based pharmaceutical product at large scale. Capacity to manufacture is crucial and the acquisition of the Flaskworks technology was a brilliant move by the company. Thanks for highlighting these topics. I can’t wait to hear more news about manufacturing DCVax-L.
March 2023 Manufacturing News:
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https://cms.mhra.gov.uk/mhra/mia/uk-mia-54923
The MIA is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA is a prerequisite of the MAA application.
“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences
https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html
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LP said that the UK facility can supply North America, but they will likely use the Memphis facility too depending on money/timing. Either facility should have enough capacity to stand alone, but they could use both.
They have been planning well to build the capacity to address a worldwide demand.
https://p.widencdn.net/ud1zkk/DS-TS-immunology-dendritic-cells-activation-assay
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Manufacturing is also crucial when considering the vast possibility of combo therapies and the possibility of treating other cancers beyond GBM.
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Don’t miss ASCO 2023! It’s starting this week!
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171909324
https://clinicaltrials.gov/ct2/show/NCT04201873
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https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
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