CGMP Scale Up

Expedite your discovery-to-market timeline by partnering with Regis Technologies to produce your Active Pharmaceutical Ingredients (APIs). 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.

Regis Technologies Scientist Evaluating Analytical Data In Expediting CGMP Scale Up Discovery To Market
Image Of Regis Technologies Chemist Working On CGMP Development In Cryogenic Reactor
CGMP Kilo Labs

Early Scale Up

Advance your candidate for early scale up, preclinical studies, and through Phase 1 clinical studies by scaling up in Regis' CGMP Kilo Labs. Regis can scale up and manufacture initial CGMP batches from 100 g to 5 kg.

Processing Equipment Includes:

  • 12 L, 22 L, 50 L & 63 L Glassware
  • Four Enclosed Suites containing:
    • Process Hoods
    • 20 L Rotary Evaporators
    • Class 100,000 Single Pass Air

Reactor Suites

Production Scale

Transition easily through Phase 2 and all the way to commercial manufacturing with Regis' CGMP Reactor suites capable of 100+ kg per batch.

Production Equipment Includes:

  • Nine Reactor Suites with Glass Lined Reactor Pairs ranging from 25 to 500 gallons
    • Glass-lined reactors
      • 2 x 25 gal
      • 2 x 50 gal (2)
      • 2 x 100 gal
      • 2 x 200 gal (2)
      • 2 x 300 gal
      • 2 x 500 gal
    • 150 gal cryogenic reactor

High Potent Compound Suite

HPAPI Scale Up

For your high potent APIs, commission Regis' Potent Compound Suite for development and CGMP production.

Processing Equipment includes:

  • Synthesis Lab with 22 L Glass Vessels
  • Expansion capability to larger scale with up to 50 L jacketed reactors
  • Isolator with built in Tray Dryer
  • Laminar Flow Hoods
  • Local Exhaust Ventilation
Learn more about Regis' high potent compound capabilities.

Facility Tour

Equipment

Learn more about our equipment and its capabilities by taking a virtual facility tour.

Regis Technologies Scientist Evaluating Analytical Data In Expediting CGMP Scale Up Discovery To Market
CGMP Kilo Labs

Early Scale Up

Advance your candidate for early scale up, preclinical studies, and through Phase 1 clinical studies by scaling up in Regis' CGMP Kilo Labs. Regis can scale up and manufacture initial CGMP batches from 100 g to 5 kg.

Processing Equipment Includes:

  • 12 L, 22 L, 50 L & 63 L Glassware
  • Four Enclosed Suites containing:
    • Process Hoods
    • 20 L Rotary Evaporators
    • Class 100,000 Single Pass Air

Reactor Suites

Production Scale

Transition easily through Phase 2 and all the way to commercial manufacturing with Regis' CGMP Reactor suites capable of 100+ kg per batch.

Production Equipment Includes:

  • Nine Reactor Suites with Glass Lined Reactor Pairs ranging from 25 to 500 gallons
    • Glass-lined reactors
      • 2 x 25 gal
      • 2 x 50 gal (2)
      • 2 x 100 gal
      • 2 x 200 gal (2)
      • 2 x 300 gal
      • 2 x 500 gal
    • 510 gal cryogenic reactor

Image Of Regis Technologies Chemist Working On CGMP Development In Cryogenic Reactor
High Potent Compound Suite

HPAPI Scale Up

For your high potent APIs, commission Regis' Potent Compound Suite for development and CGMP production.

Processing Equipment includes:

  • Synthesis Lab with 22 L Glass Vessels
  • Expansion capability to larger scale with up to 50 L jacketed reactors
  • Isolator with built in Tray Dryer
  • Laminar Flow Hoods
  • Local Exhaust Ventilation
Learn more about Regis' high potent compound capabilities.

Facility Tour

Equipment

Learn more about our equipment and its capabilities by taking a virtual facility tour.

Request for Information

Rely on our expertise to accelerate your project from preclinical to commercialization, fast. Connect with our team and learn how we can help expedite your project to the next phase.







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