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

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. 

 
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. 
 
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 cilsales@isotope.com
 
 

Frequently Asked Questions

 

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.

 
References
 
Schellekens, R.C.A.; Stellaard, F.; Woerdenbag H.J.; Frijlink, H.W.; Kosterink, J.G.W. 2011. Applications of Stable Isotopes in Clinical Pharmacology. Br J Clin Pharmacol, 72:6, 879-897. PMID: 21801197
Roswell Shelhamer

Roswell Shelhamer

Market Development Manager, Metabolic, MRI/MRS, Clinical

Ros joined Cambridge Isotope Laboratories, Inc. in 2014 as the Business Development Manager. His focus is developing new business opportunities for CIL within the MRS/MRI, Metabolomics and GMP product lines.

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