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Efficient Project Management of Outsourced Biopharmaceutical Development and Manufacturing Programs

Presented at: IBC’s 5th Annual Early to Late Stage Bioprocess Development Summit, Boston, MA October 20, 2008

Efficient and cost effective biopharmaceutical development requires coordination of numerous activities, including cell line generation, process development, preparation of reference standard, analytical method development and qualification, stability testing, and aseptic fill/finish activities. In many cases some or all of the activities are outsourced to external service providers to ensure timely completion of all tasks. Effective project management tools can be utilized by companies managing these development programs to enable seamless coordination of all activities, identify and manage critical path items, and ensure on-time and successful regulatory submissions.