"We work with a lot of companies that are just starting in their own process and looking for drugs to market," says Francis Mannerino, director of chromatography at Regis Technologies (Morton Grove, IL). "We see compounds in their earliest stage and a lot of them have difficulties in their purification. If they have a chiral separation built in, we try to marry the custom synthesis with the separation work or the purification work."Better business, better science
According to Mannerino, there are two main business advantages of SFC chiral chromatography: separations can be completed at least five times faster than separations using traditional LC and the technique uses about one-tenth of the amount of solvent, which reduces process costs and produces less hazardous waste.
"What it comes down to is speed. Getting your drug to toxicology testing faster. If you're going to fail, fail fast. Take your resources and put them into another project," says Mannerino.
The GMP road
As the first company performing SFC chiral separations under GMP, Regis faced several challenges. "For any new technique, qualifying for GMP is very trying,"says Mannerino. Fortunately, the company manufactures active pharmaceutical ingredients and finished-drug products under GMP conditions, so there were quality systems already in place. "We just needed to make the capability GMP, so it was about 40 or 50 new standard operating procedures, and we customized them for SFC equipment and personnel."
After about 10 months and several dry runs, the company gained GMP qualification. "Our challenge right now on the research side is improving productivity. There are no precedents, so we are developing different methods such as putting columns in series and using different phases in series," says Mannerino.
Increasing productivity is crucial for shortening cycle time. SFC separation is a continuous process. Once automated systems are developed and the technique is optimized, machines can run all day. "If you want a technique for commercial use, you have to optimize it as much as you can. That's the biggest challenge now:increasing productivity by doing the research," says Mannerino.