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

Low-Bioburden

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