If its available immediately, within a week, maybe
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Posted On: 04/04/2020 1:49:32 PM
Re: thriftycents #25395
If its available immediately, within a week, maybe 2. Given the current circumstances, things would move fast.
The increase in output isn't necessarily double with an added set of bioreactors though. We are likely already using more than 1 bioreactor set, but I don't know that for sure. There are so many factors that are involved with these kinds of activities, especially with contract manufacturers like Samsung. These mainly include contractual agreements and FDA permissions, on top of many other business driven decisions.
Not sure anyone here cares, but since I'm bored for obvious reasons, here's some biotech manufacturing info. Others, feel free to add, correct, or ask questions (I'm out of my 3 posts for the day after this, so I'll have to private message you with a response)
*TMI WARNING BELOW*
So I'm going to use Cytodyn's experience with Samsung to give you an idea of how things generally work. Things won't vary too much however.
First, we are talking about mammalian cell culture (similar to fermentation it terms of equipment) so if you've been to a brewery, kind of like that, but much cleaner and precise, and with a very complex filtration process.
Having Samsung Biologics as a manufacturer (the world's largest biologics manufacturer) will now pay dividends bigger than we could have ever imagined, assuming we get COVID-19 approval and need to supply much of the world. Anyways, their campus in S. Korea is massive, I mean huge. They have 3 large plants on-site, I believe. I'm not sure if all are officially commissioned at this point in time, but 2 are for sure. Any of those plants on their own would be considered a large capacity and extremely complex operation.
Just because you can make Leronlimab in one plant does not mean you are permitted by the FDA to run the same process in another plant (even if they are on the same site like Samsung). Equipment between plants, even on the same site, is not always "like for like". This means that the manufacturer, specifications, size, capability, etc are not the same, and that matters a lot. These differences bring up challenges when transferring a process to a new plant. However this problem of equipment is certainly minimized at Samsung. The equipment across Samsung's 3 plants is probably very similar, and in some cases may even be identical. Even better is, they are aware of many of the discrepancies that exist between the different equipment and plants, and know how to operate accordingly. While I'm almost certain we aren't approved to run our process in every bioreactor set at Samsung (for business reasons), gaining approval to a new plant couldn't be easier anywhere else, in my opinion, given the reasons stated above. Regardless new plant approvals still take time.
Each monoclonal antibody manufacturing process is different in terms of product yield per run. I have no idea how efficient the Leronlimab process is, my guess would be on the lower side, given the age of the program.
1 large plant probably has around 3-6 sets of bioreactors, or bioreactor 'trains'. Samsung's website states they currently have 12 trains of 15,000 L capacity between all of their plants.
Once a bioreactor train is started, it is followed by a second train some days later, followed by a third and potentially a forth, fifth, etc. The runs are staggered so that purification equipment (probably only 1-2 sets per plant) can be cycled (cleaned and equilibrated) in between processing each train. Scheduling and equipment cycling is a very complex part of the whole process. But theoretically you could have new material being produced every few days, indefinitely, once started. Just because you make Leronlimab, doesn't mean it meets quality standards (established by Cytodyn and agreed to by the FDA). I have lots of confidence in Samsung to get this done however as does the entire industry.
A run (train) takes time because you literally start with a frozen 1mL vial of cells to culture. This gets put into a small flask followed by a series of larger flasks, followed by one or more larger volume bio-bags, which is followed by multiple bioreactors, each larger than the previous one, up to 15,000+ liters in some instances (not sure about Leronlimab). This takes a lot of time, probably 6+ weeks. Then comes about a week or so of purification activities followed by formulation and vial fill operations.
The increase in output isn't necessarily double with an added set of bioreactors though. We are likely already using more than 1 bioreactor set, but I don't know that for sure. There are so many factors that are involved with these kinds of activities, especially with contract manufacturers like Samsung. These mainly include contractual agreements and FDA permissions, on top of many other business driven decisions.
Not sure anyone here cares, but since I'm bored for obvious reasons, here's some biotech manufacturing info. Others, feel free to add, correct, or ask questions (I'm out of my 3 posts for the day after this, so I'll have to private message you with a response)
*TMI WARNING BELOW*
So I'm going to use Cytodyn's experience with Samsung to give you an idea of how things generally work. Things won't vary too much however.
First, we are talking about mammalian cell culture (similar to fermentation it terms of equipment) so if you've been to a brewery, kind of like that, but much cleaner and precise, and with a very complex filtration process.
Having Samsung Biologics as a manufacturer (the world's largest biologics manufacturer) will now pay dividends bigger than we could have ever imagined, assuming we get COVID-19 approval and need to supply much of the world. Anyways, their campus in S. Korea is massive, I mean huge. They have 3 large plants on-site, I believe. I'm not sure if all are officially commissioned at this point in time, but 2 are for sure. Any of those plants on their own would be considered a large capacity and extremely complex operation.
Just because you can make Leronlimab in one plant does not mean you are permitted by the FDA to run the same process in another plant (even if they are on the same site like Samsung). Equipment between plants, even on the same site, is not always "like for like". This means that the manufacturer, specifications, size, capability, etc are not the same, and that matters a lot. These differences bring up challenges when transferring a process to a new plant. However this problem of equipment is certainly minimized at Samsung. The equipment across Samsung's 3 plants is probably very similar, and in some cases may even be identical. Even better is, they are aware of many of the discrepancies that exist between the different equipment and plants, and know how to operate accordingly. While I'm almost certain we aren't approved to run our process in every bioreactor set at Samsung (for business reasons), gaining approval to a new plant couldn't be easier anywhere else, in my opinion, given the reasons stated above. Regardless new plant approvals still take time.
Each monoclonal antibody manufacturing process is different in terms of product yield per run. I have no idea how efficient the Leronlimab process is, my guess would be on the lower side, given the age of the program.
1 large plant probably has around 3-6 sets of bioreactors, or bioreactor 'trains'. Samsung's website states they currently have 12 trains of 15,000 L capacity between all of their plants.
Once a bioreactor train is started, it is followed by a second train some days later, followed by a third and potentially a forth, fifth, etc. The runs are staggered so that purification equipment (probably only 1-2 sets per plant) can be cycled (cleaned and equilibrated) in between processing each train. Scheduling and equipment cycling is a very complex part of the whole process. But theoretically you could have new material being produced every few days, indefinitely, once started. Just because you make Leronlimab, doesn't mean it meets quality standards (established by Cytodyn and agreed to by the FDA). I have lots of confidence in Samsung to get this done however as does the entire industry.
A run (train) takes time because you literally start with a frozen 1mL vial of cells to culture. This gets put into a small flask followed by a series of larger flasks, followed by one or more larger volume bio-bags, which is followed by multiple bioreactors, each larger than the previous one, up to 15,000+ liters in some instances (not sure about Leronlimab). This takes a lot of time, probably 6+ weeks. Then comes about a week or so of purification activities followed by formulation and vial fill operations.
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