The journey from scientific discovery to drug development and commercialization is an expensive and time-intensive process. There are many phases and complex challenges to navigate, requiring the capabilities and expertise of a seasoned partner. An experienced contract development and manufacturing organization (CDMO) can help navigate the drug development journey by providing capabilities and expertise in discovery, development, and manufacturing.

Cayman's US- and EU-based end-to-end CDMO services support academic, pharma, and biotech clients across the entire drug substance development lifecycle, from drug discovery through clinical trials to commercialization.

What Sets Us Apart

Our understanding of the challenges faced by bringing a drug from molecule to market drives us to provide a client-centric approach, tailoring adaptive solutions to deliver personalized service for our clients to help them achieve their goals.

What We Offer

CGMP Services	CGMP Products & Manufacturing	Drug Discovery Services
Customized service plans for individual client needs	From preclinical to commercial human and animal health applications	Integrated chemistry and biology services from concept to candidate

CGMP Services

Cayman has a full range of CGMP services that are available as stand-alone services or as part of a comprehensive API discovery, development, and manufacturing program. We offer a collaborative, flexible approach, allowing our clients to create a customized service plan that meets their needs.

Process Development

Beginning process development early in the product life cycle sets the foundation for the successful transition of a pharmaceutical product from initial concept to large-scale production. Considering the challenges of moving from laboratory-scale production to commercialization early in the process helps ensure the manufacturing methods are efficient, scalable, reliable, and deliver high-quality final products.

At Cayman, we know that every detail matters. We leverage the extensive capabilities and diverse chemistry experience of Cayman Chemical and Cayman Pharma to create a wealth of knowledge to tap into for all areas of development, including raw material sourcing and vendor qualification, route design, the identification of key process parameters (KPPs), critical process parameters (CPPs), and hold points, analytical testing considerations, and developing quality control measures to ensure a cost-efficient uninterrupted development process to meet budget and project timelines.

CGMP API Manufacturing

Successful scalability is not just an exchange in knowledge but requires flexibility and adaptation to the process when moving from lab to commercial scale to ensure quality, safety, and consistency. 

During CGMP manufacturing, we focus on scaling up production while maintaining quality standards. We qualify methods, create batch record documents, and produce representative materials for toxicology studies and formulation work. With subsequent batches, we refine our processes to accommodate larger scales, improve yields to enhance efficiency, and establish the standards for monitoring product quality.

As drug products advance through development and are readied for commercialization, we provide launch support through process and analytical method validation to ensure consistent safety and quality by demonstrating that the manufacturing process and analytical methods produce reliable results within defined specifications.

Analytical Testing

Analytical testing occurs in parallel with process development and CGMP manufacturing to ensure product quality, consistency, and safety during all phases of the product lifecycle. Our team has the expertise and analytical capabilities to develop, qualify, and validate analytical methods as part of a comprehensive API development program or stand-alone services for projects at any phase of development.

Our analytical team customizes phase-appropriate testing programs tailored to each API's unique requirements while conforming to stringent regulatory standards that ensure consistent quality and rigorous process control.

Our Capabilities:

Qualified Outsourced Analytical Testing with Key Partners:

Analytical Instruments:

Support Services

We are dedicated to supporting the needs of our clients and ensuring their projects have a smooth and successful transition from early-stage development through commercial launch.

Quality is incorporated at every step of production to ensure each batch is produced in a controlled, standardized, and consistent way. All manufacturing processes, including raw materials and equipment used, the process parameters, and the testing procedures, are accurately recorded, and we provide documentation for quality control analyses to assist with regulatory filings.

Our experts provide guidance and help with drafting and completion of CMC sections of your regulatory documents to support your new drug applications. We continually monitor regulatory changes to evaluate the evolving expectations of regulations and guidelines that may affect regulatory filings.

Each project is conducted under the oversight of a dedicated PMP-certified project manager to keep clients informed of the process and keep things moving on time and on budget. We provide ongoing communication throughout the entire project lifecycle support through regular project status meetings and a dedicated, secure webpage for sharing information.

CGMP Products & Manufacturing

We combine our heritage and expertise to offer APIs and CGMP manufacturing for breakthrough approaches. We have certified and registered facilities that meet US FDA, EMA GMP, and ICH standards. Our GMP production site in Ann Arbor, Michigan, USA is DEA licensed for the manufacturing, importing, and exporting of DEA Schedule I-V controlled substances, and our GMP production site in Neratovice, Czech Republic is capable of manufacturing occupational exposure band category 5 (OEB-5) compounds that are extremely hazardous and require significant measures to prevent operator exposure.

With decades of experience managing the global distribution of controlled substances, our regulatory and shipping logistics teams provide a reliable, uninterrupted supply of API for your clinical trial program.

Custom APIs

With drug discovery entering a new era of AI- and machine learning-based design and optimization, Cayman is here with the medicinal chemistry and process development capabilities to help bring your novel analogs from benchtop milligram scale synthesis into multi-gram to kilogram scale. Our expertise includes nucleoside analogs, aminoisoquinoline and aminoisoquinolone analogs, heterocyclic compounds, and custom molecules upon request.

View all CGMP Products & Custom Manufacturing Services

Drug Discovery Services

Development of New Chemical Entities (NCEs) is an iterative process of design, refinement, and optimization. Our GMP clients also have access to a comprehensive suite of preclinical discovery services for target identification, compound synthesis, hit screening, and lead optimization to support your ever-evolving R&D pipeline.

Explore all Drug Discovery Services

whycayman