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You Can Outsource Manufacturing But You Can’t Outsource Responsibility

By: Susan Dana Jones, Ph.D. and Howard L. Levine, Ph.D.
Reprinted with permission of BioExecutive International, March 2005

Much has been written about the advantages of outsourcing biopharmaceutical development activities that are either not accessible internally or are not a core competency of the organization, such as manufacturing. While enlisting qualified CMOs to perform tasks including process development, manufacturing, product-specific assay development, formulation development, stability testing, and fill/finish appears to reduce the time a company needs to spend on these activities, it is essential that companies plan for enough resources to oversee each vendor and each activity that is outsourced. This oversight by the sponsor company requires a dedicated program manager, either internal or a consultant specializing in this field, who can efficiently manage the entire development program through managing the vendors and the flow of information, SOPs, and material in order to keep the product development within the intended budget and timeline.