Our ISOTEC® Stable Isotopes team specializes in the custom synthesis of labeled compounds, including the manufacturing, testing, and control of cGMP (current good manufacturing practices) materials. As science evolves, new labeled substrates are needed in a wide range of applications, including clinical study tracers, labeled amino acids for protein quantification, and metabolic research standards. Our highly trained group of stable isotope scientists are dedicated to supporting all your exploration needs. We routinely design and execute multi-step syntheses of complex labeled materials, including metabolites and steroids, fatty acids, amino acids, reference standards, pharmaceutical intermediates and other bioactive compounds.
With our on-site production capabilities and a large inventory of starting materials, we provide rapid and accurate results. Our facilities give us the capability to perform syntheses ranging from milligram to kilogram quantities, provide custom packaging services, and guarantee client confidentiality. In addition, we offer a variety of product grades, including S&P tested and full GMP certified material, with the most rigorous standards in the industry to meet customer specifications.
Our ISOTEC® Stable Isotopes team has the scientific and regulatory expertise to meet any cGMP product need. From the beginning, each project is supported by a project leader who serves as a single point of contact between you and our team of chemists. Good Manufacturing Practices are followed for the production, testing, packaging and release of regulated products. ISOTEC® is ISO-certified and its facilities are FDA inspected. Though manufactured in compliance with current regulatory requirements, all stable isotope cGMP products require further manufacturing, processing or repacking in compliance with applicable laws before being used in FDA-approved applications.
Our cGMP production team is experienced in all phases of bulk pharmaceutical manufacturing, from process development through scale-up. They can optimize the synthetic route for new compounds and process validation for later-phase projects, and routinely manufacture established bulk APIs. We also have the advantage of a reliable and consistent supply of raw materials from our catalog, including an extensive inventory of stable isotope labeled compounds.
Our analytical group of chemists and scientists continuously develop new methods to determine the chemical and isotopic purity of products by using a variety of instrumentational and compendial methods. This experience provides a strong foundation for developing and validating the analytical methods needed to ensure the quality of cGMP products. Our dedicated group develops stability-indicating assays, isotopic analyses and impurity profiles to fulfill customers’ requirements. Stability studies are performed following ICH guidelines.
Our QA team has the knowledge and expertise to fulfill customers’ cGMP regulatory needs. They are responsible for the review and approval of specifications, procedures, batch records and validation activities. They also control product releases, conduct audits and provide training. We maintain DMFs in over 15 countries and regularly provide documentation to support customers’ regulatory filings.
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