The US contract manufacturing organisation (CMO) made the comments after using Prep HPLC to produce 525 grams of pure active pharmaceutical ingredient (API) from 800gms of raw material composed of three differed chiral isomers.
The final compound, the identity of which was not disclosed, had a chiral purity of more than 99.7 per cent, and over 99 per cent achiral purity; a result which exceeds the high expectations of FDA, EMEA, or Ministry of Health (MoH) guidelines, which typically call for levels of 98 per cent for drug products.
The technique has wide ranging implications for drugmakers according to Ricerca vice president of chemical development Richard Donaldson who told Outsourcing-pharma that APIs of this kind can be “used in every drug for any disease.”
“Every approved drug has its own API, and we have worked with hundreds of different APIs,” he said, adding “we continue to work with pharmaceutical and biotech companies to help develop additional APIs for every disease group you can think of.”
Donaldson explained that APIs are manufactured under contract in collaboration with a pharmaceutical or biotech company with a specific process developed for each API for purification, but did disclose details of the specific project.
“Multiple methods of purification are used depending upon the specific API,” said Donaldson, adding: “If it is a solid, we try to purify by crystallization, but oftentimes, chromatographic purification is required.”
Such analytical procedures are carried out at Ricerca’s 40 acre US site, located in Concord, Ohio, where a Prep High-Performance liquid chromatography system has been installed.
Capable of processing as much as 1-2kg of material under cGMP controls, this equipment is fully expandable to 6-8kg capacity, and comes with an automated fraction collection system to aid the purification process. In addition to this, the APIs are purified in glass, glass lined steel, and various metal reactors, and following this, filtrations are completed, and solids are dried in vacuum ovens.
Ricerca expects demand for business to increase as the company continue to offer its custom API purification service.
“API development is the basis of our business,” said Donaldson, explaining how work at Ricerca is contracted with clients seeking “our expertise to help them develop an API into a new drug, and purification is a very important part of that development.”