Prostaglandin APIs

We manufacture the following prostaglandin APIs for commercial distribution in ophthalmologic, vascular, and animal health applications. In addition to API products, we can provide high-purity standards for related substances, impurities, and analogs for use in analytical method development and finished drug product stability studies.

Psychedelic APIs

Cayman is proud to be one of the first CDMOs offering psychedelic and psychotropic compounds for use in human clinical trials investigating the therapeutic benefits of psychedelic medicines in neuropsychiatric disorders including depression, anxiety, OCD, migraines, and more. Our team is backed by 20 years of experience in managing the regulatory challenges of the manufacturing, importing, and exporting of APIs and a variety of DEA Schedule I-V controlled substances. We can work in coordination with your formulator of choice and the DEA to secure quota and deliver psilocybin, psilocin, and other in development APIs.

Ionizable Cationic Lipids

Cayman’s CGMP expertise, capabilities, and facilities support the continuation of your R&D Lipid Nanoparticle (LNP) formulation and non-viral delivery efforts into the clinical trial stage, providing the scale-up and supply of high-purity ionizable lipid GMP excipients for use in CGMP LNP formulation. Our process development team can move the latest and most advanced ionizable cationic lipids into the pre-CGMP, investigational, and commercial manufacturing phases, including:

• SM-102
• DLin-MC3-DMA
• C14-4
• Certest Lipids
• Other novel or proprietary lipids upon request

Ancillary Materials

Cayman supplies ancillary grade materials, including modulators of stem cell differentiation, cell death, and cell signaling pathways used during the manufacturing of cell-based therapeutics, such as CAR T-cell, personalized cancer vaccine, and gene editing (CRISPR) approaches. Ancillary materials must be manufactured to the highest quality standards as they are critical for safety and quality of the finished therapies but are not intended to be part of the final drug product. Our portfolio of RUO, ancillary, and GMP ancillary products offers consistency in product sourcing and quality as your manufacturing protocols advance from discovery, through clinical trials, and into commercial stages.

Qualified GMP Analytical Reference Standards

Cayman supplies qualified Analytical Reference Standards (ARS) appropriate for qualifying Active Pharmaceutical Ingredients (APIs) and Pharmaceuticals. These materials are meticulously characterized to ensure that manufacturers can verify the identity, purity, and potency of APIs and drug products. Cayman meets the regulatory requirements for ARS including guidelines for their qualification, documentation, traceability and compliance with agencies including the FDA, EMEA, and ICH.

Custom CGMP Development & Manufacturing

Leverage our CGMP Manufacturing services for the development and manufacturing of investigational API products. Our expertise includes nucleoside analogs, aminoisoquinoline and aminoisoquinolone analogs, heterocyclic compounds, and custom molecules upon request.