research reports and media, page-3876

Thank you jcurve. That is an amazing paper. It confirms exactly what I have written about a number of times here, on the fact that PPS is not some simple molecule that can be produced as a generic, but a very complex mixture of many kinds of structural variants that is virtually impossible to replicate without knowing every step of the secret production process.

I think I hit all these items in previous posts:
These include Mw, PD, DS, heterogeneities of the used biological starting material, process-related changes of the and inhomogeneous sulfation.

These initials are: molecular weight, polydispersity (how big a range of molecule sizes are in the mixture), degree of sulfation (how many sulfate groups are attached to the backbone). Inhomogenous sulfation refers to the degree to which the sulfate groups are evenly spread along the chain, or clumped together in groups.

The paper concludes:
The structural differences most likely resulted from the individually applied production processes and confirm the well-established principle 'the process defines the product' in the field of biological and non-biological complex drug substances.

In other words, you can't start with the product specification and work backwards to get the process. It's like a trapdoor function, it only works in one direction. I don't think we will see generics anytime soon, if at all.