cGMP

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, our 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.

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

To request a custom quotation please complete this form or call 1.800.322.1174 or email cilsales@isotope.com.

Clinical Research Substrates

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Product category

Isotope Label

Label Type

Isotopic Enrichment Range

Grade

Molecular Weight Range

Product Form

Product Form 2

Clinical Research Substrates

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

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
– FT-IR
– Polarimetry
– TOC

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