Ann: PAT-DX1 GMP specification testing update, page-23

Hi Matt,
I'm just putting this (The latest WHOGuidelines for the production and quality control of monoclonal antibodies
and related products intended for medicinal use ) out as a weekend reading to keep the hopes alive and given the relevance of the issue of Biological Standardizzation.
Particularly interesting are passages on pages 11 and 12 on Heterogeneity and page on page 15 on Special Considerations.
After reading it there may be a renewed sense of optimism that there may be ways to overcome these final obstacles with the possibility of fine tuning the final substance up to the very start of the trials:

https://cdn.who.int/media/docs/default-source/biologicals/final-who-guidelines-on-mab-production-and-quality-control-annex-4---7-jun-2022.pdf?sfvrsn=8c542f00_1&download=true