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contract manufacturing organization
A Contract Manufacturing Organization (CMO), sometimes called a Contract Development and Manufacturing Organization (CDMO), is an organization that serves the pharmaceutical industry and provides clients with comprehensive services from drug development through manufacture.〔(Contract Pharma ). Contract Pharma. Retrieved on 2013-09-18.〕
Services offered by CMOs include, but are not limited to: pre-formulation, formulation development, stability studies, method development, pre-clinical and Phase I clinical trial materials, late-stage clinical trial materials, formal stability, scale-up, registration batches and commercial production.
==Evolution==
The pharmaceutical market uses outsourcing services from providers in the form of contract research organizations (CROs) and contract manufacturing organizations. In recent years, the concept of a comprehensive single-source provider from drug development through commercial manufacture has emerged. This concept has been implemented by providers known today as contract development and manufacturing organizations (CMOs).
CMOs are a response to the competitive international nature of the pharmaceutical market as well as the increasing demand for outsourced services.〔Taylor, Phil. “Outsourcing of production gaining pace in big pharma” (()), Outsourcing Pharma.com, May 27, 2008. Retrieved 7-3-08.〕 The best-positioned service providers focus on a specific technology or dosage form and promote end-to-end continuity and efficiency for their outsourcing clients. With lower-cost international manufacturers capturing an increasing percentage of the contract manufacturing market, specialization may be an effective hedge against loss of market share.〔Spurgeon, Tom. “Continuity and Connectivity: We Can Do That, Too” “(subtitle) Are CDMOs the Next Big Thing?” (()), Contract Pharma, March 2008:70–74. Retrieved 7-3-08.〕
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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