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. CMOs are contract manufacturers, but they can also be more than that because of the development aspect. 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 the 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. Advantages The bio/pharma companies used to build and staff dedicated manufacturing capacities for drugs in development only to see them canceled if the product failed in Phase III of clinical research; working with  CMO limits that financial risk. Disadvantages The pharmaceutical client using the services of a CMO does not have direct control of the project regarding scheduling, cost, quality, or accountability. Data security is an issue to be considered when selecting a CMO, as intellectual property and another proprietary data are exchanged between client and service provider. One of the major risks remains in the lack of control over the CMO's compliance for the client, for example when an FDA warning letter is issued, a resulting interruption of production may result in major delay or interruption of shipping. The rise of the CMO industry led to an increase of inspectors from various divisions of the Food and Drug Administration (e.g.: Center for Biologics Evaluation and Research or Center for Drug Evaluation and Research).
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. CMOs are contract manufacturers, but they can also be more than that because of the development aspect. 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. Advantages The bio/pharma companies used to build and staff dedicated manufacturing capacities for drugs in development only to see them cancelled if the product failed in Phase III of clinical research; working with a CMO limits that financial risk. Disadvantages 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. Data security is an issue to be considered when selecting a CMO, as intellectual property and other proprietary data are exchanged between client and service provider. One of the major risk remains in the lack of control over the CMO's compliance for the client, for example when an FDA warning letter is issued, a resulting interruption of production may result in major delay or interruption of shipping. The rise of the CMO industry led to an increase of inspectors from various divisions of the Food and Drug Administration (e.g.: Center for Biologics Evaluation and Research or Center for Drug Evaluation and Research).
D
,
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the
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canceled
cancelled
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a
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regarding
in regard to
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another
other
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risks
risk