Plasma proteins are only a small component of plasma, which is made up mostly of water. This means it takes a lot of plasma to make therapeutics. Having an efficient process to manufacture plasma proteins is highly desirable.
All commercial manufacturers currently servicing the North American market extract plasma proteins using a process called “cold ethanol fractionation” that was developed in the 1940s and includes cold alcohol steps and pH adjustments.
We are developing an efficient new and proprietary chromatography process for manufacturing plasma proteins. It has demonstrated high yields for existing therapies and provides for potential access to novel therapies of high quality and purity from the precious supply of plasma to address unmet patient demand. Therapure is currently manufacturing its lead therapy at clinical scale in preparation for in human trials in 2016.
Learn more about our pipeline of plasma proteins.
The manufacturing of these products is regulated by Health Canada and by the FDA in the United States. Additionally, the Plasma Protein Therapeutics Association’s (PPTA’s) Quality Standards of Excellence, Assurance and Leadership (QSEAL) program goes beyond the regulations to ensure quality and safety of the final products.