Clinical Research/GMP

With increasing requirements from institutional review boards (IRBs) and governmental agencies, partnering with 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 on 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. Since 1994, CIL has manufactured bulk active pharmaceutical ingredients (APIs) in its 15,000-square-foot, state-of-the-art cGMP facilities.

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

Clinical Research Substrates

Clinical Research Substrates

Manufacturing Capabilities

• Dedicated development facility
• Seven production suites
• Dedicated packaging room
• Production scale from grams to multi-kilograms
• Clinical trials to bulk API
• Customizable projects to meet your needs

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

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
– Polarimetery

Kevin in GMP lab
GMP lab equipment

Example References

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