CGMP 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.

Regis also offers separation services using prep HPLC, Biotage units, and large gravity columns.

SFC Separation Services

CGMP And Non-GMP Options

Regis holds a CGMP mindset for all projects and offers CGMP compliant Quality Control support for both CGMP 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
  • CGMP 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

Why Choose Regis?

Added Value From Regis

  • 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
  • CGMP 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.

Regis Custom Pharma

Additional Capabilities

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

Learn more about our:

SFC Separation Services

CGMP And Non-GMP Options

Regis holds a CGMP mindset for all projects and offers CGMP compliant Quality Control support for both CGMP 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
  • CGMP 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

Why Choose Regis?

Added Value From Regis

  • 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
  • CGMP 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.

Regis Custom Pharma

Additional Capabilities

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

Learn more about our:

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