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CGMP & nonGMP SFC SEPARATIONS

Supercritical Fluid Chromatography (SFC) using carbon dioxide has gained acceptance as the method-of-choice in the preparative separation of stereoisomers in racemic mixtures. Although a well-established technology for over 20 years, renewed interest emerged with the recent introduction of high throughput SFC systems required for pharmaceutical applications.

RegisSEP™ Separations Service is a valuable addition to our chromatographic services. A superior method with cost and time efficiencies, RegisSEP™ offers GMP compliant separations service with benefits other separation methods cannot provide for chiral compounds.

SFC SEPARATION SERVICES

CGMP AND non-GMP OPTIONS

Regis Technologies separations scientist working with chiral compounds on Thar SFC in non-GMP SFC separations lab
Regis holds a GMP mindset for all projects and offers GMP compliant Quality Control support for both GMP and non-GMP synthesis services.
 
CGMP Scale-up
Regis offers an SFC scale-up service in a dedicated lab that is fully compliant with Current Good Manufacturing Processes for:
  • Separations from small scale analytical to kilogram preparative separations
  • GMP chiral purification for clinical trials and formulation studies
Non-GMP Separations
Regis' non-GMP SFC lab provides:
  • Separations from small scale analytical to kilogram preparative separations
  • Deliverables include individual isomers, method, analytical HPLC data and report
  • On average ≥97% ee and ≥80% recovery
  • Extended library screening for difficult separations
 

WHY CHOOSE SFC?

COST EFFICIENCIES

Supercritical fluid chromatography provides a superior separations service for chiral compounds with cost and time efficiencies from:

  • Faster processing time
  • Lower solvent use and waste
Regis Technologies separations scientist preparing for chiral purification in cGMP SFC separations lab

WHY CHOOSE REGIS?

ADDED VALUE FROM REGIS

Regis Technologies separations scientist in cGMP SFC separations lab near Thar SFC
  • Free chiral HPLC method screening & assessment process
  • Formal method development and validation if needed
  • Separation capabilities from milligram to kilogram scale
  • Wide range of organic synthesis expertise and equipment if required for further isomer processing or synthesis
  • GMP compliant organization with support services including: Analytical Method Development, Quality Assurance, Quality Control, Stability, and Project Management
  • Decades of separation expertise from a recognized chiral column manufacturer
  • Operating in a central US location at Regis' main facility in Morton Grove, IL

A SIMPLE PROCESS

START TODAY

Start with a free screening of your compound  to determine if a preparative SFC separation is best. This process is simple and includes completing a confidentiality agreement (if desired), our Chiral Screen Submission form, an Environmental Health & Safety (EHS) form, and sending your compound to Regis. Regis completes most screenings upon the day of receipt  so that you receive results within three days.

Contact us to start the process at amiles@registech.com.

REGIS CUSTOM PHARMA

ADDITIONAL CAPABILITIES

Trust in Regis Custom Pharma for your small molecule active pharmaceutical ingredient (API). We are committed to advancing your projects from initial process development, scale-up development through final validation and commercial manufacturing. Partner with Regis to bring your pre-clinical, clinical, and commercial APIs to the next level.

Learn more about our:
Regis Technologies chemist checks reactor used for manufacturing small molecule APIs

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