CLINICAL

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.

An additional team of experts – specializing in synthetic chemistry, customer support, quality control, and quality assurance – serves to provide technical guidance from beginning to end of your project.

Buchem BV is proud distributor for CIL products in the Benelux.

- Fluxing Through Cancer
- Stable Isotope Labeling Kinetics (SILK™) to Measure the Metabolism of Brain-Derived Proteins Implicated in Neurodegeneration
- Stable Isotopes in Drug Development and Personalized Medicine: Biomarkers that Reveal Causal Pathway Fluxes and the Dynamics of Biochemical Networks
- Product Quality Designation Chart

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-I
• 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

Contact us for further information.