Amyloid fibril formation

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So I worked doing a scientific project and we were super strict, so it's why I'm saying if the test don't bring up fibril it's most likely just keeping the same standard for medication.

For example I would use the same tempture, from the same water source everyday during the scientific study we did, why? Eliminate any reasons for skewed results. Less things to blame.

They say stability, but does that mean Fibrosis happens if it's not or does it just mean they want to now it's the exact age, reconstitution, pH, tempture etc?

Like I said not saying "don't be questioning" this, it's not approved, but so far I haven't had anything say otherwise.

The linked design document talks about them testing a wide variety of formulations with different salt bridges, etc., at two different pH levels specifically because of trying to strike a balance between solubility, efficiency, and resistance to fibril formation. They have data on fibril formation at a pH of 7.5 - the study specifically looked at it. They could have chosen that as the 'standard' for the final version.

But the final patent specifies a pH of 3.5 to 4.5

 

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For me, the easy answer is, I'm not smart enough to know who is right and I don't actually need to use cagrilintide. So I don't.