Metabolic Research

Clinical/Diagnostic MS

cGMP Capabilities

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. Click here for additional information.


  • cGMP Capabilities
  • Stable Isotopes in Drug Development and Personalized Medicine
  • Stable Isotope Labeling Kinetics (SILK™) to Measure the Metabolism of Brain-Derived Proteins Implicated in Neurodegeneration
  • BioMarker Discovery Flyer

CIL has the capabilities to supply compounds suitable for all different phases of clinical trials. Each cGMP product is manufactured, tested, packaged and released according to current Good Manufacturing Practice. Customers can be assured that they will receive a wide range of support throughout each cGMP project.

 

Clinical Mass Spectrometry Product Listing
Research Use Statement
Product Quality Designation Chart
 
 
 
Heavy-Labeled MS Protein Standard Human IGF-1 Datasheet
Labeled Biological Standards for Quantitative Mass Spectrometry

 

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.

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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Krista Backiel

Krista Backiel

Marketing Manager and Metabolomics Manager

Krista is responsible for managing and promoting products that are utilized in Metabolomics and Clinical/Diagnostic MS. She spends a lot of her time developing new products to assist customers in their diverse research efforts.

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  Related Products


Download Labeled Biological Standards for Quantitative MS

 

CIL Expansion
In order to better service the needs of our valued customers, CIL has expanded its cGMP Production and Quality Control suite to approximately 10,000 square feet.