(Total Views: 1240)
Posted On: 07/27/2020 11:05:49 AM
Post# of 153897
Quote:Not sure what they can do 4 years later.
Interesting.... I wonder what their capacity is. Perhaps this is a play to help scale our manufacturing...
Source Link: https://www.cytodyn.com/investors/sec-filings...12d10k.htm
Quote:
We have developed and validated a current good manufacturing practice (“cGMP”) process to manufacture PRO 140, through a single contract manufacturer, FUJIFILM Diosynth Biotechnologies U.S.A., Inc. This contract manufacturer previously produced multi-Kg scale bulk batches of PRO 140 under cGMP for our Phase 2 clinical studies and is capable of producing sufficient quantities of PRO 140 for all the clinical studies required prior to submitting a BLA to the FDA. In addition, we have undertaken certain comparability studies which supported the use of previously manufactured amounts of PRO 140 in current and planned clinical studies. This process has been completed and all PRO 140 drug substance can be used in our clinical trials.
(0)
(0)
