My understanding is that AGC has been the producer
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Posted On: 07/07/2020 9:06:43 AM
My understanding is that AGC has been the producer of smaller batches of product used for clinical trials. I don't believe they currently have large production capacity, but that would hopefully change once the Bolder, CO facility comes online in April. My understanding is that the FDA would have to approve that facility, but I don't know any of those specifics.
http://www.agcbio.com/resource-center/news/ag...-offerings
My understanding is that Ajinomoto Bio-Pharma has provided aseptic fill finish services for product used in COVID clinical trials. And I initially assumed that relationship would expand after approval, but I am no longer thinking that way.
https://www.ajinomoto.com/media/covid-19/ajin...cal-trials
I read the recent PR regarding the exclusive distribution and supply agreement signed with American Regent (for US COVID only), looked at their website, and watched their video:
https://www.americanregent.com/video/
I also took note of their list of distributors/wholesalers, which includes the likes of McKesson, AmerisourceBergen, Cardinal Health, Henry Schein, and HD Smith:
https://americanregent.com/distributors/
My conclusion (right or wrong) is that American Regent will maybe provide aseptic fill finish services for US COVID and coordinate product distribution using THEIR existing list of distributors/wholesalers.
They do not seem to be a distributor/wholesaler. They seem to have their own products which maybe puts them in a good position to coordinate fill finish, billing and logistics for CytoDyn's product. But that's just a guess.
https://www.americanregent.com/our-products/
Now, I believe that CytoDyn had a license agreement with Lonza back in 2015:
CytoDyn Q1-2017 10K
Lastly, I just say that the sands have been shifting quite a bit regarding the availability of product:
Earlier this year, we heard that AGC would hopefully begin delivering 600-700k vials beginning in June/July, and Samsung would hopefully deliver 1.2M vials, with capacity for maybe 5M vials by August/September.
The Samsung part of the equation then morphed into 1.2M vials this year, with the possibility perhaps of 3M vials by the end of the year.
And that subsequently morphed into what we are hearing now as Samsung is booked and they can supply 1.2M vials this year.
I don't know what happened to the 600-700k vials AGC was going to begin delivering in June/July.
No matter how you slice it, that has the appearance of a big haircut, and a trend that is going in the wrong direction. If Samsung is really booked for the rest of the year, that would be unfortunate (for the CytoDyn, the US, and the World). And if Samsung has represented to Dr.NP that they only have capacity for 10M vials in 2021, that's an even bigger problem. I hope these sands shift again in a positive direction if we are granted FDA approval.
Lastly, everything above is pure conjecture on my part.
http://www.agcbio.com/resource-center/news/ag...-offerings
My understanding is that Ajinomoto Bio-Pharma has provided aseptic fill finish services for product used in COVID clinical trials. And I initially assumed that relationship would expand after approval, but I am no longer thinking that way.
https://www.ajinomoto.com/media/covid-19/ajin...cal-trials
I read the recent PR regarding the exclusive distribution and supply agreement signed with American Regent (for US COVID only), looked at their website, and watched their video:
https://www.americanregent.com/video/
I also took note of their list of distributors/wholesalers, which includes the likes of McKesson, AmerisourceBergen, Cardinal Health, Henry Schein, and HD Smith:
https://americanregent.com/distributors/
My conclusion (right or wrong) is that American Regent will maybe provide aseptic fill finish services for US COVID and coordinate product distribution using THEIR existing list of distributors/wholesalers.
They do not seem to be a distributor/wholesaler. They seem to have their own products which maybe puts them in a good position to coordinate fill finish, billing and logistics for CytoDyn's product. But that's just a guess.
https://www.americanregent.com/our-products/
Now, I believe that CytoDyn had a license agreement with Lonza back in 2015:
CytoDyn Q1-2017 10K
Quote:But I am not aware of any existing production agreement.
Effective July 29, 2015, we entered into a License Agreement (the “Lonza Agreement”) with Lonza Sales AG (“Lonza”) covering Lonza’s “system know-how” technology with respect to CytoDyn’s use of proprietary cell lines to manufacture new PRO 140 material.
Lastly, I just say that the sands have been shifting quite a bit regarding the availability of product:
Earlier this year, we heard that AGC would hopefully begin delivering 600-700k vials beginning in June/July, and Samsung would hopefully deliver 1.2M vials, with capacity for maybe 5M vials by August/September.
The Samsung part of the equation then morphed into 1.2M vials this year, with the possibility perhaps of 3M vials by the end of the year.
And that subsequently morphed into what we are hearing now as Samsung is booked and they can supply 1.2M vials this year.
I don't know what happened to the 600-700k vials AGC was going to begin delivering in June/July.
No matter how you slice it, that has the appearance of a big haircut, and a trend that is going in the wrong direction. If Samsung is really booked for the rest of the year, that would be unfortunate (for the CytoDyn, the US, and the World). And if Samsung has represented to Dr.NP that they only have capacity for 10M vials in 2021, that's an even bigger problem. I hope these sands shift again in a positive direction if we are granted FDA approval.
Lastly, everything above is pure conjecture on my part.
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