Small Scale Manufacturing

Small-Volume Manufacture of APIs

Purisys offers a flexible, high-containment suite with controls in place to produce compounds of OEL<500 ng/m3, and systems in place to create low bioburden-grade APIs for parenteral applications (including milling capabilities). Special adaptations in suite design, equipment design, operations and process safety afford developers a single location to produce on a flexible, small-volume GMP scale. You can then advance through clinical stages and finally to commercial production of small-volume APIs.

cGMP Production

  • FDA-inspected commercial manufacturing facility
  • Flexible equipment design to support gram to multiple kg scale
  • Four R&D labs and one commercial QC lab
  • State-of-the-art equipment, including a lyophilizer and glass reactors up to 150L


  • Class 100,000 clean room environment
  • Additional design features and procedures to operate as class 10,000 for non-sterile parenteral grades

High Potency

  • Ability to handle high-potency and cytotoxic substances (OEL<500 ng/m3)
  • Closed-charge charging/discharging systems and equipment

Labile Compounds

Processing of highly-sensitive materials – such as oxygen, light, heat and moisture.

At Purisys, we offer more than access to state-of-the-art suites. We provide:

  • An expert team of chemists and engineers to help optimize small-scale manufacturing
  • Comprehensive analytical, regulatory, physical properties and stability support
  • Integration of quality by design to API development and manufacture

Purisys reduces your time to market with a customer-focused and knowledgeable regulatory affairs team to supply comprehensive documentation, from IND support to commercial filings.

Key Equipment

  • Twin 150L Reactors
  • 50L Glass Reactors
  • 20L Glass Reactors
  • 5L Glass Reactors
  • 5L Basket, SS Centrifuge
  • SS Vacuum Tray Dyer
  • Fitzpatrick SLS with High-Speed Comill and Fitzmill Heads
  • 50L Glass lined Steel Reactors
  • 20L Heated, Agitaged Charge Tank
  • 100L Heated, Agitated Phase Split tank
  • 60L Hasteloy Filter Dryer
  • Column Chromatography
  • Lyophilizer
  • 20L Rotovap System
  • Nutsche Filter Dryer
  • Small Volume Encapsulation

Auxiliary Equipment and Storage

  • Teflon Buchner Funnels
  • Fine dosing pumps
  • pH meters
  • Glove Box
  • 2 DEA Vaults for Bulk Storage: -20°C, 2-8°C, and RT Conditions
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