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by ghc 2054 days ago
BioNTech is different from a small biotech that can only produce drug candidates. They have their own advanced manufacturing plant and can take it end to end. Their US branch, which my wife is a part of, has all the in-house expertise needed to take a cancer therapy or vaccine to market in the US, just like Moderna does.

If I’m not mistaken the reason for the partnership is the sheer size of the clinical trials needed (very different from cancer therapies) and the speed at which they need to be run due to the pandemic. Only big pharma can do that.
1 comments
refurb 2054 days ago
I didn't know they had manufacturing capabilities. Looking at their manufacturing page, they do have GMP manufacturing facilities, but it looks like they were built around their oncology pipeline, which would be customized for each patient and low volume (as you mentioned).

https://biontech.de/how-we-translate/manufacturing

And unless I'm mistaken, they don't have any approved products on market? No doubt they have experts in house, but when you're racing to get a product to market, it can be very helpful having someone like Pfizer helping out who has successfully gotten 70+ products approved by the FDA (including several vaccines).

And interestingly, you'll even see these partnerships across big pharma. I worked for one company who was interested in bringing a gene therapy in house until we did our due diligence and realized holy shit, we know nothing about gene therapies. And this was a top 5 pharma company.

link
ghc 2054 days ago
Unfortunately my wife leads a team coordinating R&D conversion to manufacturing so I have no idea what I can or cannot say that isn't on the website.

But from my perspective the regulatory process is a lot easier to navigate than the supply chain. Even if you get through all the trials, manufacturing a billion doses and distributing them across a supply chain is a special kind of hard that only companies like Pfizer can handle.

So while BioNTech doesn't need help bringing an oncology therapy to market (it just takes time because cancer is hard), it needs a company like Pfizer to actually get it to patients, both in phase 3 trials and after approvals.

link