ROOWIN S.A.: Contract Research Organization in Fine Chemistry and Life Sciences
ROOWIN S.A. is a privately owned Contract Research Organization (CRO) headquartered in Riom, Auvergne, France. Founded in 1997, the company operates within the Biotech and Life Sciences sector, with its core business concentrated in high-value added fine chemistry and synthetic chemistry. Its primary mission is to support pharmaceutical and biotechnology companies in the design, optimization, and scale-up of chemical routes and robust analytical methods for their drug candidates.
The company acts as a comprehensive partner, assisting clients from the early stages of drug discovery and research through advanced process development, ultimately supporting the out-licensing of Active Pharmaceutical Ingredients (API) in Phase II or supplying the market with small batches, typically up to approximately 20 kilograms. ROOWIN S.A. is equipped to support projects requiring adherence to current Good Manufacturing Practices (cGMP) for toxicology studies and Investigational New Drug (IND) applications.
Continue…Products and Services
ROOWIN S.A. offers a comprehensive suite of chemical services, designed to cover the entire development lifecycle of a drug candidate. These services are delivered through several key departments:
1. Drug Discovery and Custom Synthesis
The company specializes in organic synthesis and medicinal chemistry, tackling complex challenges in custom synthesis and providing advanced intermediates. ROOWIN's expertise allows it to either work on known syntheses or independently establish required chemical routes. The scale of synthesis projects ranges from small laboratory amounts (starting at 50 milligrams) for medicinal chemistry needs, up to several dozen kilograms for later-stage development.
Products delivered in this area are typically research-grade compounds, advanced chemical intermediates, and final drug candidates in their exploratory phases.
Services include:
* Process Development and Optimization.
* Synthesis of advanced intermediates and drug candidates.
* A broad range of specialized chemical reactions, including hydrogenation, bromination, nitration, Curtius reaction, chiral chemistry, chiral separation, and photochemistry.
* Handling of cytotoxic and sterile products within dedicated glove boxes.
2. GMP Synthesis (Active Pharmaceutical Ingredient Production)
ROOWIN's cGMP synthesis capabilities focus on the custom manufacturing of Active Pharmaceutical Ingredients (APIs) and other materials required for clinical trials. The company's facilities are designed for full compliance with cGMP standards and are subject to audits by major pharmaceutical customers. Complete production-related documentation is provided throughout a cGMP project, with minute tracking of every step from raw material identification and purchase to final batch release.
Products delivered are cGMP-grade APIs for clinical studies (from exploratory to advanced clinical phases) and GLP-grade lots for toxicology studies.
Facilities supporting GMP synthesis include:
* cGMP Kilolab: Equipped with 2x 25 L Glass Lined vessels.
* cGMP Pilot Plant: Features dedicated, separately-suited areas with glass-lined and Hastelloy vessels ranging from 30 L to 130 L, capable of operating from -80°C to +150°C.
* High-End Process Equipment: Includes large-scale hydrogenation (e.g., Hastelloy 20 L reactor) and industrial photochemistry (a 10 kW photoreactor).
3. Analytical Chemistry and Quality Control
As a critical complement to its synthesis activities, ROOWIN maintains strong analytical chemistry capabilities, operating an Analytical Laboratory for development and non-cGMP analysis, and a Quality Control (QC) Laboratory for cGMP analysis. These operations comply with ICH (International Conference on Harmonization) guidelines.
Services offered by the analytical department include:
* Analysis on demand using existing methods.
* Chiral or non-chiral separation services.
* Development and/or validation of analytical methods.
* Stress and Stability Studies.
Key Equipment includes a wide array of sophisticated instrumentation:
* Spectroscopy: 300 and 500 NMR multi-nodes (H, C, F, N, P), FTIR (ATR), UV, DAD.
* Chromatography: 11 HPLC systems, 2 UPLC/MS systems, 5 GC systems (including GC/MS), and Ionic Chromatography.
* Thermal/Physico-chemical Analysis: DSC (Differential Scanning Calorimetry), TGA (Thermogravimetric Analysis), Karl Fischer (KF) titration, and ICP-AES (Inductively Coupled Plasma Atomic Emission Spectroscopy).
