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Key advice
Think ahead. The earlier you address many issues the better.
Involve the production department from the beginning. Consider scalability from the beginning. Use inexpensive and standard buffer systems only and chromatography resins that have regulatory support files and offer secure supply. Avoid resins with animal derived additives if possible.
- Prepare a master validation plan and try to integrate validation work in the development project as early as possible
- Address regulatory issues up front to ensure that the product meets relevant standards
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