[refurb]

Similar to the reason why most small biotechs don’t get credit when a big pharma company launches their drug - coming up with a drug candidate is critical and really hard, but it gets you about 1/3rd of the way to the market (at least as measured by dollars). Taking it through clinical trials, regulatory approval and manufacturing is a complex (and massively expensive) process that requires expertise typically only big pharma has (not to say smaller company don't roll their own, they do, but they are often slower and sometimes stumble).

And this is to not downplay BioNTech's role. Proving that your idea works in biotech takes some massive cohones. No doubt they took a ton of shit on their way to this point.

[ghc]

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.

[refurb]

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.

[ghc]

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.