Facilities – Sales and Service Worldwide
CIL products have contributed to advances in drug discovery and development, biomarker discovery, medical diagnostics, high technology, and environmental analysis. Under the umbrella of parent company Otsuka America Pharmaceuticals, Inc. (OAPI), the CIL Group is comprised of six companies.
Deuterated NMR solvents, stable isotope-labeled chemicals and gases, environmental standards, as well as specific cGMP products. Headquarters are located in Tewksbury, Massachusetts, USA, with production in Tewksbury and nearby Andover, both just north of Boston.
CIL World Headquarters and cGMP Production Laboratories
Tewksbury, MA USA
CIL corporate headquarters consist of a 40,000-square-foot facility housing the executive team, as well as sales, marketing, finance, quality assurance, regulatory affairs, and cGMP production and quality staff. In addition to corporate office space, the facility includes a 10,000-square-foot state-of-the-art cGMP suite, which includes multiple production laboratories, dedicated isolation rooms, a dedicated analytical laboratory, a packaging laboratory, and a development laboratory.
CIL Production Laboratories
Andover, MA USA
CIL’s primary production facility is dedicated to the manufacture of deuterated NMR solvents, stable isotope-labeled chemicals and gases, single- and multi-component formulations, as well as specific cGMP products. This 57,000-square-foot facility is home to operations, production, formulations, and quality. The production group has expertise in isotope synthesis and has produced thousands of highly pure, stable isotope-labeled compounds and reagents. The formulations group has extensive experience preparing these labeled materials into high-quality quantitative solutions as analytical standards, either as single-component products or multicomponent mixes and calibration solutions. The quality-control (QC) lab is equipped with a wide array of instrumentation, including liquid chromatography-mass spectrometry (LC-MS), gas chromatography (GC-MS, GC-FID), high-field NMRs, HPLCs with a variety of detectors, and FT-IR. CIL’s chemistry laboratories are equipped with apparatus for both large-scale (50+ liters) and microscale chemistry, including equipment for high-pressure gas reactions, pH and temperature-controlled enzyme chemistry, high-resolution distillation processes and catalytic reduction with both hydrogen and deuterium. The production laboratories are also equipped with analytical equipment for in-process testing, including GC-FID, GC-ECD and HPLC with UV, RI, ELSD, and MS detectors. These resources support CIL in its mission to consistently produce products with high chemical and isotopic purity.
CIL Tewksbury, MA
CIL Andover, MA
CIL Isotope Separations, LLC
Xenia, OH USA
• Separation of 13C and 18O
• Re-enrichment of D2O
• Deuterated solvent production
• ISO 9001: 2015
Carbon-13 Isotope Separation Facility
CIL is recognized as the world leader in the separation of 13C. In the 1980s, CIL took the initiative to construct a 13C isotope-separation plant in order to provide a sufficient supply of 13C starting materials to support research and diagnostic developments. Since then, CIL has continued to expand its 13C-production capacity to maintain its leadership position in the separation of 13C.
Oxygen-18 Isotope Separation Facility
In 2000, CIL responded to the worldwide shortage of 18O water by constructing its own 18O isotope-separation facility; it quickly became a leading producer of 18O. To further support the growing needs of the nuclear medicine community, CIL has continually increased production capacity of 18O since the initial construction. With each expansion, CIL has maintained its position in the field by responding to the worldwide demand for 18O water used in positron emission tomography (PET) and energy-expenditure studies
D2O Re-enrichment Capabilities
This facility also houses the world’s only commercial deuterium oxide (D2O) enrichment columns, which provides CIL with additional deuterium to be used as a raw material for production, minimizes waste, and reduces dependence on external sources.
Deuterated Solvent Production
To support the growing demand for deuterium and deuterated compounds for commercial applications, CIL continuously expands production at CIS. Deuterium gas and deuterated solvents are made on a large scale by well-controlled ISO 9001 processes that yield highly enriched end products.
Euriso-Top is Europe’s leading producer of deuterated solvents and stable isotope-labeled compounds, with the most complete product offering available. Since 1991, when Euriso-Top was founded by a group of researchers from the Commissariat à l'Energie Atomique (CEA), the team has continuously strived to provide customers with high-quality products and comprehensive technical support. Euriso-Top's quality control and production laboratories are equipped with NMR, MS, HPLC, GC, IR, UV, and Karl Fischer (KF) instruments. Euriso-Top offers stable isotope-labeled compounds, isotopic gases, NMR solvents, isotopic metals, cGMP products, among other products. Through its customer and technical support, Euriso-Top aims to form strong partnerships with stable-isotope users in Europe and Asia. Euriso-Top has been a fully owned subsidiary of Cambridge Isotope Laboratories, Inc. since 2001.
PET precursors, FDG reagents kits, PET and SPECT precursors and reference standards, manufacturing of reagents kits and cassettes, FDG, FLT, F-choline, NaF, FMISO, FES and FET production.
ABX is the world’s leading supplier of 18F positron emission tomography (PET) precursors and reagent kits and cassettes, including kits for fluorodeoxyglucose (FDG), fluorothymidine (FLT), F-choline, NaF, F-miso, and FET, among other products. ABX specializes in the manufacture and development of chemicals for nuclear medicine. Its facility includes cGMP-approved laboratories, Class 100 clean rooms and cGMP radiochemistry development hot lab, which uniquely position ABX to provide complete PET and SPECT chemistry solutions to radiochemists and radiopharmacists worldwide. ABX’s radiochemistry hot lab is equipped with most of the leading commercial PET tracer synthesis boxes and allows ABX to assist customers with the optimization and development of new tracers.
ABX is a leader in the production and development of PET and SPECT precursors and reference standards and the manufacturing of reagents kits and cassettes, particularly kits for FDG, FLT, F-choline, NaF, FMISO, FES, and FET production. ABX employs over 160 professionals, many of which specialize in the design, custom synthesis, and production of peptides, in both research and cGMP settings. This can also include the performance of stability studies. ABX has a strong R&D pipeline for the development of new radiotracers, labeling and purification strategies, and kits and cassettes in collaboration with pharmaceutical companies. This location houses facilities for the production and filling under pharmaceutical conditions Class 100 and is audited and accepted as cGMP API manufacturer by German pharmaceutical authorities and the US Food and Drug Administration (FDA). ABX holds a US and European Drug Master File (DMF) for mannose triflate (FDG precursor) and maintains its own software for PET evaluation, ROVER. ABX is now CIL’s distributor of 18O water, FDG grade and cGMP grade.
Carbohydrates, enriched media, and amino acids for drug-discovery applications.
CIL Canada, Inc. is CIL‘s biotech laboratory facility, which produces carbohydrates, enriched media, and amino acids for drug-discovery applications. CIL Canada specializes in algal biosynthesis, including spirulina, chlorella, and a variety of other algal strains for NMR and proteomics applications. It has an additional specialty in the enrichment of sodium borodeuteride, with 12 reaction ovens dedicated to continuous production. CIL Canada's 12 technicians and chemists have more than 170 years combined algal biosynthesis experience. In March 2021, the company became ISO 9001:2015 certified.
CIL Canada's product expertise includes:
• Isotopically labeled glucose production (12C, 13C, 2H/D)
• Spirulina for animal feed (15N, 13C, 2H/D)
• Glycerol (13C, 12C, D)
• Celtone and Celtone Plus
• Isotopically labeled algal cells enriched media
Amino acids (synthetic)
CIL has an established business office located in Shanghai, China, for its direct sales team to support local distribution channels and to best serve the expanding Chinese market. This location hosts collaborative meetings with distributors, customers, and key opinion leaders, strengthening CIL’s commitment to this market. Chief areas of support include pharmaceutical and industrial manufacturing, life sciences research and development, and environmental testing.