(Total Views: 537)
Posted On: 04/04/2020 4:43:09 PM
Post# of 154064
I can vouch for the validity of the Mfg info listed by OTC newbie
I Worked for years at a Mfg facility that made vaccines (but not from eggs)
The drug substance saw was grown and purified in bioreactor and purification columns. Then conjugated and formulated into drug product that was filled on as aseptic filing line (picture people in Bunny suits in a sterlile filling room.
This is why I have been harping for months on the need to get the CMC (Mfg) section of the BLA submitted.
The first manufacturing approval is key.
While it is not easy to bring up another Mfg facility or even line within a facility with the three validation batches required etc. , the CMC section really needs to be submitted and approved to enable our commercial success.
IMO
I Worked for years at a Mfg facility that made vaccines (but not from eggs)
The drug substance saw was grown and purified in bioreactor and purification columns. Then conjugated and formulated into drug product that was filled on as aseptic filing line (picture people in Bunny suits in a sterlile filling room.
This is why I have been harping for months on the need to get the CMC (Mfg) section of the BLA submitted.
The first manufacturing approval is key.
While it is not easy to bring up another Mfg facility or even line within a facility with the three validation batches required etc. , the CMC section really needs to be submitted and approved to enable our commercial success.
IMO
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