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Some considerations on manufacturing — there’s a variety of product quality steps necessary to release batches of medicine. The FDA mandates this as part of GMP

Some considerations on manufacturing — there’s a variety of product quality steps necessary to release batches of medicine. The FDA mandates this as part of GMP regulations. These steps help ensure things like: * How do I know that every vial has the same concentration of insulin each time? That is to say 1 unit from a vial today and 1 unit from another vial is going to have the same dosing. * How do I know the insulin is purified? If there’s any host cell protein in the vial, that could be immunogenic and cause bad side effects. * How do I know that the formulation of insulin in the vial won’t degrade on me at whatever storage condition is stated? I realize that these tests make up only a small fraction of the price, but there’s a lot of value to purchasing medicine from regulated sources. I’m not against upstart competition against big pharma, but I worry that you might literally kill someone if you don’t include these product quality steps in your process.

tomaszs 5y ago
It makes sense. On the other hand pharmaceutical companies make mistakes also, just on a bigger scale. Also I imagine that when it will be easier to set up insulin small scale production, than more scientists will be able to do innovate and improve the process.
shkkmo 5y ago
> there’s a lot of value to purchasing medicine from regulated sources. I’m not against upstart competition against big pharma, but I worry that you might literally kill someone if you don’t include these product quality steps in your process. Where are you getting this from? This goal of this isn't to have every diabetic brewing insulin in their garage so they evade the IP police in a distrubuted fasion. The goal is to create open IP needed for creation, purification and quality control that will allow labs around the world to create insulin in keeping with local regulations.
- YHK 5y ago
  Thank you. This is exactly what we are trying to do. It is difficult for us to get rid of the mad scientist label. We have a team in fact that evaluate the FDA requirement and looking at what would be the best way to do it. Also, Open IP means for us that we will share the modified strains which are optimized for the expression of the insulin, and ideally, we will be able to provide scientific knowledge and resources to help the creation of local manufacturing plant.
  - LinuxBender 5y ago
    Off topic question: Is there a database maintained by BioHackers that has reverse engineered some or all of the prescription pharmaceuticals, showing not only the compounds used, but how to make, measure and test them? There are government sites that list all the chemical compounds, but details are scattered all over the place on how to make, measure and test them. Asking as a prepper that wants to stock up on food, water and medications. Doubling or tripling BP prescriptions is insufficient by my standards.
    - YHK 5y ago
      The four thieves vinegar is doing something like that (https://fourthievesvinegar.org/ https://fourthievesvinegar.org/) They work also on patented molecules and try to reverse engineer proces, and then publish it. (which makes it illegal, so they are anonymous) I don't know how many molecules they published though.
      - LinuxBender 5y ago
        Ah yes I think I've seen that site posted here before. Last I checked they didn't have a big database, but maybe I didn't dig deep enough into the site. The Download the Apothecary MicroLab Plans go to a status page that says to check back later.
        YHK 5y ago
        Yeah I saw that. It is a bummer, I want to take a look at it now. I will try to ask around to see what is happening there.
      - dnautics 5y ago
        IANAL, but reverse engineering process is almost certainly not illegal. Don't know where you got that idea. If they cribbing off a "process patent" then it's not reverse engineering, though, IIRC, for most drugs companies don't bother getting a process patent because they are very difficult to enforce (to enforce such a patent, you need a warrant to go onto a competitor's premises and inspect their process, and judges are very very unlikely to issue such a warrant because if they set a low bar precedent for such actions, then basically everyone is going to start issuing spurious claims), so everyone would rather just build their moat with trade secrets than process patents. Also, I believe if you crib off of a process patent to do a one-off run or research project it is not illegal, only commercializing it is. One (ostensible) point of patents is to encourage sharing and desiloing knowledge and keep things out of the dark so that we can learn from each other.
- erosenbe0 5y ago
  What IP police? It's off-patent. You just need to be a compounding pharmacy I think.
kortex 5y ago
The FDA won't let anything be released to consumers that does not pass their review of the batch record. The whole point of the BR is it's the recipe in totality of how to correctly (which includes quality) make the drug. The whole point is to open source the batch record.

tomaszs 5y ago

It makes sense. On the other hand pharmaceutical companies make mistakes also, just on a bigger scale. Also I imagine that when it will be easier to set up insulin small scale production, than more scientists will be able to do innovate and improve the process.

shkkmo 5y ago

> there’s a lot of value to purchasing medicine from regulated sources. I’m not against upstart competition against big pharma, but I worry that you might literally kill someone if you don’t include these product quality steps in your process. Where are you getting this from? This goal of this isn't to have every diabetic brewing insulin in their garage so they evade the IP police in a distrubuted fasion. The goal is to create open IP needed for creation, purification and quality control that will allow labs around the world to create insulin in keeping with local regulations.

YHK 5y ago
Thank you. This is exactly what we are trying to do. It is difficult for us to get rid of the mad scientist label. We have a team in fact that evaluate the FDA requirement and looking at what would be the best way to do it. Also, Open IP means for us that we will share the modified strains which are optimized for the expression of the insulin, and ideally, we will be able to provide scientific knowledge and resources to help the creation of local manufacturing plant.
- LinuxBender 5y ago
  Off topic question: Is there a database maintained by BioHackers that has reverse engineered some or all of the prescription pharmaceuticals, showing not only the compounds used, but how to make, measure and test them? There are government sites that list all the chemical compounds, but details are scattered all over the place on how to make, measure and test them. Asking as a prepper that wants to stock up on food, water and medications. Doubling or tripling BP prescriptions is insufficient by my standards.
  - YHK 5y ago
    The four thieves vinegar is doing something like that (https://fourthievesvinegar.org/ https://fourthievesvinegar.org/) They work also on patented molecules and try to reverse engineer proces, and then publish it. (which makes it illegal, so they are anonymous) I don't know how many molecules they published though.
    - LinuxBender 5y ago
      Ah yes I think I've seen that site posted here before. Last I checked they didn't have a big database, but maybe I didn't dig deep enough into the site. The Download the Apothecary MicroLab Plans go to a status page that says to check back later.
      - YHK 5y ago
        Yeah I saw that. It is a bummer, I want to take a look at it now. I will try to ask around to see what is happening there.
    - dnautics 5y ago
      IANAL, but reverse engineering process is almost certainly not illegal. Don't know where you got that idea. If they cribbing off a "process patent" then it's not reverse engineering, though, IIRC, for most drugs companies don't bother getting a process patent because they are very difficult to enforce (to enforce such a patent, you need a warrant to go onto a competitor's premises and inspect their process, and judges are very very unlikely to issue such a warrant because if they set a low bar precedent for such actions, then basically everyone is going to start issuing spurious claims), so everyone would rather just build their moat with trade secrets than process patents. Also, I believe if you crib off of a process patent to do a one-off run or research project it is not illegal, only commercializing it is. One (ostensible) point of patents is to encourage sharing and desiloing knowledge and keep things out of the dark so that we can learn from each other.
erosenbe0 5y ago
What IP police? It's off-patent. You just need to be a compounding pharmacy I think.

kortex 5y ago

The FDA won't let anything be released to consumers that does not pass their review of the batch record. The whole point of the BR is it's the recipe in totality of how to correctly (which includes quality) make the drug. The whole point is to open source the batch record.