Janoshik Interview

[Rido]

I don't think implying all aggregates and bigger than 0.22 um is anywhere near true.


This is extreme falsehood.


Could you point me to, for example, somatropin monograph requiring so?
LCMS is basically unheard of in pharmacopeia. Bioassay is used exactly once in qualifying the product and particle analysis is not conducted in any manner other than dimer and aggregate analysis of *filtered* preparation. As far as I can tell.

Thank you.

@Ghoul please respond

 

[hexagonal]

the one where i dont have to download theres nothing useful. im not downloading anything xd

The one without the download literally says that bioassays are still required as part of the monograph

 

[janoshik]

I certainly won't claim to be an expert, but it does look like in the US at least, the monograph does include bioassays for either the bulk or prepared material. It's possible I'm misinterpreting this, as it's just my googling.

https://www.drugfuture.com/Pharmacopoeia/usp38/data/v38332/usp38nf33s2_c126.html

https://downloads.regulations.gov/FDA-2004-P-0214-0008/attachment_1.pdf

Bioassay is used exactly once in qualifying the product

I don't think what you've written, nor what is linked is in discordance with my statement.

Cheers

 

[hexagonal]

I don't think what you've written, nor what is linked is in discordance with my statement.

Cheers

I'm not an expert which makes me hesitate to disagree with you, but my interpretation of the FDA documentation out there really leads me to a different conclusion.

For example, if we look at the NDA for Serostim, it specifically mentions the rat bioassay being used to measure potency.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020604_s040_serostim.pdf

Serostim® is a highly purified preparation. Biological potency is determined by measuring the increase in the body weight induced in hypophysectomized rats.

This is written quite "present tense" which I suppose isn't a guarantee of anything, since most of the writing on these inserts is present tense, but to me does still imply a more ongoing nature.


My understanding of things is that while it is possible that bioassays can be replaced with validated tests later on in manufacturing, but that this is not a guarantee for all drugs, and that it is still a process that takes time and a track record of both methods being consistent in their results. (e.g. https://www.fda.gov/media/162263/download ). I'm not entirely sure how to interpret the 'bioassays are still required' bit in the monograph, but specifically calling it out seems strange if all it is saying is that somatropin follows the usual standards and not stating that there are additional requirements around it.


If the bit in the monograph really isn't stating anything of interest, it still seems like the answer would be "Bioassays would be done at licensure, and at least continuing on until post-licensure approval is given to change to a validated alternative." But determining if and when any such switchover occurred would require either the company disclosing it or us somehow gaining access to the confidential CMC data. But my best interpretation of the information available to me is that bioassays would be done for at least some period of time in the manufacturing process post qualification and not just a one and done sort of deal.


I very well could be wrong and don't want to come across as saying I'm definitively correct - just explaining what I've read and how I've interpreted it. It's certainly possible that interpretation is incorrect.

 

[dinfaralt]

I'm not an expert which makes me hesitate to disagree with you, but my interpretation of the FDA documentation out there really leads me to a different conclusion.

im not gonna reply to everything you said

please look up what a bioassay is and conclude we already have it on humans with hgh.

you're mismembering the definition because of ghoul ai not understanding what he is spitting out.

why would you test hgh in vivo in janolab when we already know what it does in humans?

all jano does is confirm its hgh. you have spun this a very fun direction xd