Supercritical Fluid Chiral Separations - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Supercritical Fluid Chiral Separations
The combination of supercritical fluid chromatography with chiral separation media offers several analytival advantages over traditional liquid chromatography techniques.


Pharmaceutical Technology


In progress

Productivity will play a big role in future advances in SFC chiral methods. Much of the problem in progressing the technique stems from the fact that a lot of SCF work so far has been conducted with proprietary compounds and information is not available.

Regis scientists are conducting studies involving different chiral phases from two manufacturers, with one column in a series being used for mixing. "I think the biggest improvements will come in the machinery. Advances in the machinery and feedback from companies will move the technology forward," says Mannerino. "When a manufacturer does research, it a completely different story than when it is done in other settings. We are in constant communication with equipment manufacturers."

As with any chromatographic technique, continued compliance with US Food and Drug Administration regulations is an issue. For this reason, the approval of SFC chiral methods is another important factor in its success. "A validated synthesis will always be favorable over a chromatographic technique, even when it doesn't make sense financially or scientifically,"says Mannerino. Perhaps the greatest obstacle, however, is convincing high-level personnel. "It's just fighting old-school thinking,"he says. have a lot of upper management in companies that didn't grow up with advanced chromatography techniques, and they didn't go to school or internships with it. There are so many variables that you can't explain in chromatography, and so in their eyes it's not a reliable technique. Many organic chemists won't buy into it. It's changing slowly."

This article is based on an interview with Francis Mannerino, director of chromatography at Regis Technologies (Morton Grove, IL).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
24%
Attracting a skilled workforce
29%
Obtaining/maintaining adequate financing
15%
Regulatory compliance
32%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology,
Click here