Contract manufacturing organization

From Wikipedia, the free encyclopedia
Jump to: navigation, search

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.[1]

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[edit]

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.[2] 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.[3]

Advantages[edit]

Outsourcing to a CMO allows the pharmaceutical client to expand its technical resources without increased overhead. The client can then manage its internal resources and costs by focusing on core competencies and high-value projects while reducing or not adding infrastructure or technical staff. Virtual and specialty pharmaceutical companies are particularly well-suited to CDMO partnerships, and big pharmaceutical companies are beginning to view relationships with CDMOs as strategic rather than tactical.

Working with a CMO also limits a client’s upfront capital investment for drug development, thus minimizing a project’s cost. By concentrating resources with a single-source provider, the outsourcing client can minimize technical transfer of projects or products, thereby reducing unforeseen costs and potentially speeding new products to market.

Disadvantages of CMOs[edit]

The pharmaceutical client using the services of a CMO does not have direct control of the project in regard to scheduling, cost, quality or accountability. Security is an issue to be considered when selecting a CMO, as intellectual property and data are exchanged between client and service provider.

See also[edit]

References[edit]

  1. ^ Contract Pharma. Contract Pharma. Retrieved on 2013-09-18.
  2. ^ Taylor, Phil. “Outsourcing of production gaining pace in big pharma” ([1]), Outsourcing Pharma.com, May 27, 2008. Retrieved 7-3-08.
  3. ^ Spurgeon, Tom. “Continuity and Connectivity: We Can Do That, Too” “(subtitle) Are CDMOs the Next Big Thing?” ([2]), Contract Pharma, March 2008:70–74. Retrieved 7-3-08.