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