Lonza manufacturing: Please consider this: P
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Posted On: 07/07/2020 6:24:12 AM
Lonza manufacturing:
Please consider this:
Preparations Underway For Commercial Scale-Up
Currently, CytoDyn is producing 2,000 liters per run, with immediate capacity to produce 12,000 liters per run. Upon approvals of leronlimab for its various indications, Pourhassan plans to leverage Samsung Biologics’ 180,000 liter-per-run capacity and Lonza’s 150,000 liter capacity to facilitate the product’s commercial scale-up. And while it’s currently filled to vials, he says the company is already planning the switch to prefilled syringes of leronlimab to meet commercial demand. “The transition to prefilled syringes is strategic for both patient centricity and supply chain efficiency,” explains Pourhassan. “The patient will simply remove the syringe from its box, self-inject, and dispose of the syringe per the instructions on the box. This will eliminate the waste of a significant amount of material.”
[url=https://www.bioprocessonline.com/doc/the-perilous-development-of-a-potential-biologic-blockbuster-0001[/url]
I checked the images of the vials you can find on the net. One vial contains 1,4 ml of LL. A 2000 L run therefore should result in approx. 1.4 million vials.
NP mentioned in one of the calls that the 1,2 million vials would come in staggered over the period July to December and not all would be available beginning of July. I therefore assume that payment issues are ongoing .
Further delays, even if the first batch did arrive from Korea already, could stem from the fact that LL now needs to be packaged by AGC into vials.
Perhaps I have this all wrong would therefore appreciate any feedback.
Greetings from Germany
baggo-mh
Please consider this:
Preparations Underway For Commercial Scale-Up
Currently, CytoDyn is producing 2,000 liters per run, with immediate capacity to produce 12,000 liters per run. Upon approvals of leronlimab for its various indications, Pourhassan plans to leverage Samsung Biologics’ 180,000 liter-per-run capacity and Lonza’s 150,000 liter capacity to facilitate the product’s commercial scale-up. And while it’s currently filled to vials, he says the company is already planning the switch to prefilled syringes of leronlimab to meet commercial demand. “The transition to prefilled syringes is strategic for both patient centricity and supply chain efficiency,” explains Pourhassan. “The patient will simply remove the syringe from its box, self-inject, and dispose of the syringe per the instructions on the box. This will eliminate the waste of a significant amount of material.”
[url=https://www.bioprocessonline.com/doc/the-perilous-development-of-a-potential-biologic-blockbuster-0001[/url]
I checked the images of the vials you can find on the net. One vial contains 1,4 ml of LL. A 2000 L run therefore should result in approx. 1.4 million vials.
NP mentioned in one of the calls that the 1,2 million vials would come in staggered over the period July to December and not all would be available beginning of July. I therefore assume that payment issues are ongoing .
Further delays, even if the first batch did arrive from Korea already, could stem from the fact that LL now needs to be packaged by AGC into vials.
Perhaps I have this all wrong would therefore appreciate any feedback.
Greetings from Germany
baggo-mh
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