cGMP Capabilities | Eurisotop

cGMP Capabilities

CIL has been manufacturing bulk active pharmaceutical ingredients (API’s) since 1994 and has been continuously increasing the cGMP product offering through the years in an attempt to support clinical research. It is important to note that CIL works with many different clients on cGMP projects including academic, small pharmaceutical, large pharmaceutical as well as biotech start-up companies.

 

With increasing requirements from institutional review boards (IRBs) and governmental agencies, partnering with Cambridge Isotope Laboratories, Inc. (CIL) for your next stable isotope cGMP project can help ensure your regulatory compliance. With the world’s largest 13C and 18O isotope-separation plants, CIL is able to provide the raw materials necessary for your project. Your compound of interest most likely already appears in CIL’s extensive list of research compounds – if not, CIL’s team of PhD chemists can determine the best method of synthesis for incorporating 13C, 15N, deuterium, 17O, and/or 18O into your compound. CIL has manufactured bulk active pharmaceutical ingredients (APIs) since 1994. It recently added a 15,000-square-foot, state-of-the-art cGMP facility to complement its existing cGMP facilities.

 Manufacturing Capabilities

• Dedicated development facility
• Five production and two isolation suites
• Dedicated packaging room
• Production scale from milligrams to multikilograms
• Clinical trials to bulk API
• Customizable projects to meet your needs
 
Analytical Services
 
• Fully equipped analytical facility
• Method development and validation
• Raw material and final product testing
• Wet chemistry and compendial methods
• Stability studies and chambers
• Dedicated cGMP instruments and facility
• Analytical instrumentation:
        – High-field NMR (1H, D, 13C, 15N, multinuclear)
        – HPLC with UV, RI, ELSD, DA, Pickering, and MS detection
        – GC with FID, ECD, and MS detection
        – KF
        – FT-IR       
        – Polarimetery
        – TOC
    

Quality and Compliance

• Drug master files
• FDA-audited facility
• QA release of API product
• Follows FDA and ICH guidances
• CMC sections for NDA or IND