Friday, March 02, 2018 9:37:24 PM
About the manufacturing process of DCVAX-L and DCVAX-Direct.
Marnix Bosch at ASCO 2015 - Overview of DCVax Direct Phase 1 Trial
"DCVAX Direct: 7- day manufacturing process using a highly controlled, cost-effective, proprietary manufacturing system."
Min 1.35
Marnix Bosch at ASCO Conference June 5, 2017: DCVAX Update on Clinical Programs
“DCVAX Direct is manufactured using a proprietary, automated manufacturing system."
https://www.nwbio.com/NWBio_ASCO_Update_On_Trials_6-5-17.pdf
Les Goldman at World Vaccine Congress april 2015.
Min 23.45 : “In the operable DC Vaccine what we do is over seven days in the laboratory we expose the baby dendritic cells which we can learn, relearn they’re not shutt off like the adults are and pick up all of those biomarkers ……”
So it looks like Marnix Bosch (DCVAX Direct) an Les Goldman (DCVAX-L) are talking about the same 7 day manufacturing process.
From RKMatters post 68221: 10 day manufacturing process.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=124239254
“In 2009, they reveal it is already cleared Batch Manufacturing (to 10 day) for their IND and in use, as we learn with long-tail follow-up data:
http://www.prnewswire.com/news-releases/northwest-biotherapeutics-receives-approval-of-us-patent-for-cost-saving-automation-of-high-concentration-dcvaxr-manufacturing-78507867.html
All within the release:
“Use of NWBT's automated system has already been cleared by FDA for human clinical trials. The INDs (Investigational New Drug applications) which have been cleared by the FDA for five different cancers include use of the automated system in the manufacturing process for DCVax®. “
Dr. Marnix Bosch, Chief Technology Officer of NWBT. "NWBT has already achieved significant cost efficiencies by pioneering a unique batch manufacturing process. These efficiencies will be further enhanced by the automated system we have developed, and it is very gratifying to receive the allowance of this important US patent on our automated device."
“The batch manufacturing process takes only 10 days. The shelf life and potency of the frozen DCVax® product have been validated.”
And we know they incorporated the Batch manufacturing change into their technology, as their 2009 Long Tail Follow-up Data confirms the manufacturing went down to 10 day process.
http://www.biospace.com/News/northwest-biotherapeutics-release-long-term-data/159857
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