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Posted On: 07/06/2020 3:37:49 PM
Post# of 155134
Re: mid-term additional capacity. Two cents that date 20 years back when I was in a biotech that brewed Mabs. We had 2 plants with many different sized bioreactors. We regularly moved production between the two based on best use of equipment. It was a deal but not a huge deal. We would even do the starter (1L -> 10L -> 50L) in one plant and the big grow (12KL back then) in the other.
It's definitely about approval, not tech feasibility. Drug makers don't build their own bioreactors, they all operate to the manufacturers' procedures (maybe two or 3 makers today?) filed with the FDA. Probably easier to get approval of a new drug at a previously approved facility of basically same design, even under different ownership, than get a same-owner facility newly approved. Getting just the big grow approved might simplify more.
In terms of "big grow" manufacturing times, the fastest we had was 8 days, the slowest 42 days in the bioreactor.
It's definitely about approval, not tech feasibility. Drug makers don't build their own bioreactors, they all operate to the manufacturers' procedures (maybe two or 3 makers today?) filed with the FDA. Probably easier to get approval of a new drug at a previously approved facility of basically same design, even under different ownership, than get a same-owner facility newly approved. Getting just the big grow approved might simplify more.
In terms of "big grow" manufacturing times, the fastest we had was 8 days, the slowest 42 days in the bioreactor.
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