cGMP | Cambridge Isotope Laboratories
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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.
• Five production and two isolation suites
– 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– FT-IR
– Polarimetery
– TOC
Quality and Compliance
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.
