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Process and Analytical Transfer

For a professional and thorough transfer process to take your project or product to the next stage, you can expect more from Siegfried.

From early development phase, Siegfried plans and designs processes that ensure a successful scale-up and transfer to commercial production. 

Our development and production scale equipment share common design and geometry that has production capacity for all materials, including high potency substances with occupational exposure levels of 1-10 µg/m³. With this consistency in equipment and process type, we ensure an optimal process transfer and scale-up for manufacturing campaigns.

Siegfried supports complete process transfer of your product, either to Siegfried’s Malta site, your own location, or, if necessary, to a Siegfried partner location.

Services:

  • Transfer of analytical methods (including cleaning validation)
  • Transfer and/or scale-up of the production process
  • Process qualification and validation
  • Manufacture and release of registration batches
  • Organization of the packaging according to customer specifications
  • Stability testing according to ICH
  • On-site support with implementation at the manufacturing plants
  • Trouble-shooting and problem solving
  • Support in registration activities
  • Life cycle management
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