As of June 12, 2018 our Privacy Policy has been updated. For individuals in the European Union, CIL uses cookies on this website. Please review the new privacy statement to see how. By continuing to use this website you agree to us using cookies in accordance with our privacy statement. Click here for the new privacy statement..OK

Clinical Research

cGMP | Cambridge Isotope Laboratories

cGMP Capabilities – Clinical Research Substrates

CIL has been routinely manufacturing cGMP products since 1994 and has been continuously increasing the cGMP product offering throughout the years in an effort to support clinical research. CIL is ISO-13485 certified and its facilities are inspected by the FDA on an ongoing basis. 

  • cGMP Capabilities – Clinical Research Substrates
  • CIL Product Quality Designation Chart
  • Stable Isotope Labeling Kinetics (SILK™) to Measure the Metabolism of Brain-Derived Proteins Implicated in Neurodegeneration
  • Stable Isotopes in Drug Development and Personalized Medicine

Clinical Research Substrates


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. 

Partner with CIL to help you meet your increasing regulatory compliance requirements. 
Manufacturing Capabilities

cGMP Quality and Compliance

• 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
cGMP manufacturing Capabilities        – 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
To request a custom quotation please complete this form or call 1.800.322.1174 or email

Frequently Asked Questions 

Are there different levels of cGMP products?

Yes, there are different levels of cGMP products that are suitable for different phases of clinical trials as well as bulk active pharmaceutical ingredients (APIs) depending on your regulatory requirements.

Are CIL's cGMP products sterile?

CIL's cGMP products can be tested in bulk form for microbiology as agreed upon by the customer. They are not guaranteed sterile or suitable for any intended use upon receipt of order.

What cGMP products does CIL currently make?

Does CIL offer products for clinical trials?

Yes, CIL can produce cGMP grade material that is suitable for clinical trials. Please contact us to discuss your project.

Stiede, K.; Miao, W.; Blanchette, H.S.; et al, 2017.  Acetyl-coenzyme A carboxylase inhibition reduces de novo lipogenesis in overweight male subjects: a randomized, double-blind, crossover study. Hepatology, 66(2), 324-334. PMID: 28470676
Schellekens, R.C.A.; Stellaard, F.; Woerdenbag H.J.; et al. 2011. Applications of stable isotopes in clinical pharmacology. Br J Clin Pharmacol, 72(6), 879-897. PMID: 21801197