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Successfully Managing Biopharmaceutical Manufacturing Outsourcing

Presented at: IQPC 4th Annual Contract Manufacuring Forum — Workshop San Diego, California, May 22, 2006

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, 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 sponsor company requires a dedicated project manager, either an internal professional or a consultant who specializes in this field, who can:

  • Efficiently manage the entire development program through managing the vendor and flow of information
  • Manage the SOPs
  • Manage the material in order to keep the product development within the intended budget and timeline

This workshop addresses these critical issues and suggests best practices and proven strategies that attendees can implement when they return the office.