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The Outsourcing Decision: Which Assays and Methodologies are Best to be Outsourced and Which Should be Developed Internally?

Presented at: BioProcess International Analytical and Quality Summit Cambridge, MA, June 2, 2008

The importance of analytical testing to biopharmaceutical manufacturing cannot be overemphasized. At all stages of development and production, analytical results impact processing decisions and the ultimate quality of your product. Decisions about outsourcing analytics are critical, and selection of a testing facility is as important as selection of a manufacturing facility. This presentation discusses the general approach to decisions on outsourcing of testing as well as concerns on outsourcing specific methods and the potential impact on your product.