Within its custom manufacturing department, Roowin studies all projects of API synthesis under cGMP (current Good Manufacturing Practices).
Roowin can produce batches in a wide range of quantities (from 50 mg up to several dozen kilograms) and support the development of APls from the exploratory stage to advanced clinical phases.
Throughout a cGMP project, Roowin provides complete production-related documentation, satisfying the highest industry standards.
From identification and purchase of raw material, through detailed intermediate analysis and up to final batch release, Roowin minutely tracks every step on the way to the final API.
Our facilities include:
- cGMP Kilolab: 2x 25 L Glass Lined vessels, -50°C to + 150°C
cGMP Pilot Plant: 2 dedicated separately suites
One with 30 L Glass Lined vessels, -50°C to + 150°C and 130 L Glass Lined vessels, -50°C to + 150°C
One with 30 L Glass Lined vessels, -50°C to + 150°C and 130 L Hastelloy vessels, -80°C to + 150°C
- Hydrogenation: Stainless Steel 2 L (120 bar, 350°C) and Hastelloy 20 L (30 bar, 140°C)
- Chromatography: 2 Novasep preparative systems: Columns from LC50, LC80 and LC110 (Diameter: 75, 80, 110 mm), with normal, inverse and chiral phases
- Photochemistry: an industrial 10 kW photoreactor
- Glove boxes dedicated to handle cytotoxic and sterile products