Kraig Biocraft Laboratories Inc (KBLB)

[GTman1]

When Kraig Labs manufactures these existing pharmaceutical proteins, do you know what regulatory hoops they would have to jump through to get the necessary approvals? How long would it take to begin manufacturing?

In short, there will be a lot. For one, they would need to become a GMP (Good Manufacturing Practice) facility. This would almost certainly entail them on-shoring this process within the U.S. or Europe to comply with FDA or EMA. This process requires the company to comply with frequent scheduled/unscheduled walk-throughs with these agencies for compliance purposes. Luckily, the value of protein expression platforms is high enough to support this type of endeavor. Even if Kraig labs cut costs in half, that would be billions in savings for these large pharmas.

Secondly, the manufacturing of the drug itself would need to be in lock-step with clinical trials. if the end drug is manufactured with silkworms, then the drug used in every phase of the trial (besides pre-clinical) will need to be suppled from silkworms. The manufacturing presses needs to be identical. As I said in my previous post, even if the protein is the same, there could be post-translational modifications that fold the protein slightly different which could make the final protein react different ways. For example, a Humira mAb produced from mammalian cells could have slightly different binding affinities than one produced with a silkworm platform. If there are differences, are they advantageous? Disadvantageous? benign? who knows. That is why the manufacturing process will need to be identical (or close to it) to the final drug manufacturing.

If Kraig Labs partners with a pharmaceutical company, do you have any guesses as to who that might be?

I don't know who the potential partners would be. I think it depends on the partnership route they decide to go. It's possible that they partner with one specific pharmaceutical company. For instance, they partner with a phizer or Roche, or Glaxosmithkline. The deal could be for exclusive rights to produce the proteins for that specific partner for all future proteins. Or, they could take the route similar to Brammer Bio (now part of Thermofisher) where they offer up their manufacturing services to everyone in the industry in regards to viral vector production for gene therapy. Large biopharmas contract out a certain amount of production capacity for production. Other pharmas will actually have designated suite space within Brammer's facility specifically dedicated to these individual companies. The options are vast, and for me to predict would just be a guess.

The good news is that most of these deals happen in advance. Any major interest from a pharma company would have deals with upfront cash and likely royalty payments, along with milestone payments as they wade through the FDA and clinical trial process. So IF the break-though is, in fact, a new protein production platform, then I would expect a partnership agreement to follow shortly afterwards.

These processes will take years before an approved drug is on the market. But partnerships with upfront cash, along with (hopefully) the fiber side of the business in full swing, we should have a much higher valuation. A new protein production platform would attract the eyes of many other people, especially in the biotech space.