CDMOs

CDMO stands for contract development and manufacturing organization. CDMOs provide outsourced development and manufacturing services to pharmaceutical, biotechnology, and medical device firms, handling both early-stage product development and later-stage or commercial manufacturing. The term emphasizes the combination of development work with manufacturing scale-up, distinguishing it from organizations that focus solely on manufacturing or testing.

Core services typically span formulation and process development, analytical method development and validation, technology transfer, and scale-up from laboratory to production scale. CDMOs may produce clinical trial materials and, for some clients, commercially launched products. They also handle quality systems, stability studies, packaging, labeling, and regulatory support for CMC sections in filings.

Clients include small biotech firms and large pharmaceutical companies seeking capital efficiency, access to specialized facilities, and flexible capacity. CDMOs offer project-based or long-term partnerships, with pricing models that transfer development risk and capital costs from sponsor to service provider. Geographically, CDMOs operate globally, often with multiple manufacturing sites to support diverse regulatory jurisdictions and supply chains.

Regulatory and quality framework: CDMOs operate under current good manufacturing practice (cGMP) and other applicable regulations. They implement robust quality management systems, data integrity controls, audits, and continuous improvement programs. Intellectual property protection, confidentiality, and clear contract terms are important considerations in client relationships.