Process Development

Our team of highly skilled chemists specialize in fit-for-purpose route design of complex, multi-step organic syntheses. They leverage the extensive capabilities and diverse chemistry experience of Cayman Chemical to improve process development and accelerate innovation. Our team embraces a quality by design approach to maximize throughput and process understanding, ensuring seamless technology transfer during process scale up for CGMP manufacturing and commercialization. When project requirements change, our team can respond quickly to new project needs.

• Extensive scientific & technical expertise
• Process development & optimization
• Route scouting
• Process safety assessments
• Material sourcing & vendor qualification

CGMP API Manufacturing

Our expertise ensures a smooth transition during production scale-up that maintains process efficiency and consistent product purity. Our dedicated CGMP production space supports API production from multi-gram to multi-kilogram quantities, and our team has a proven history of CGMP compliance during all phases of API manufacturing.

• Quality support from pilot to commercial manufacturing
• Scale-up from multi-gram to multi-kilogram quantities
• Technology transfer
• Process improvement & validation
• Continued process verification

Chemistry Capabilities

Our CDMO Services group benefits from Cayman’s synthetic chemists, medicinal chemists, process chemists, and chemical engineers who offer decades of experience and extensive knowledge to drive route development.

• Prostaglandins & prostanoids
• Nucleoside analogs
• Aminoisoquinolines & related analogs
• Tryptamines & other psychedelics
• Ionizable cationic lipids
• Heterocyclic compounds
• Custom molecules upon request

Analytical Testing

Cayman provides comprehensive analytical method development, qualification, and validation services to ensure product quality, consistency, and safety during all phases of API manufacturing. Our analytical team customizes phase-appropriate analytical testing programs to tailor to the individual requirements of each API while conforming to stringent regulatory requirements.

• API characterization & physicochemical properties
• Forced degradation & stability studies
• Structure & impurity identification
• Method development & validation
• Qualification of reference standards

Support Services

We provide end-to-end support services at every stage to help advance your drug development program.

Quality Oversight

Quality oversight is involved at every step of production to maintain strict adherence to regulatory guidelines and requirements.

Regulatory & Documentation Support

We provide documentation to assist with regulatory filings from IND through ANDA or NDA and ensure they are submitted on time to help advance your drug development. Cayman Chemical is routinely inspected by the US-DEA and fully licensed for the manufacturing, importing, and exporting of DEA Schedule I-V controlled substances.

Project Management

A PMP-certified project manager is assigned to be a single point of contact for information and regular communication to lead our clients through the drug development cycle.