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Capabilities at a glance

  • Full development of synthetic route
  • Raw material analysis
  • Process safety
  • Process optimization
  • Scale-up from lab to pilot to commercial
  • Full development of analytical methods
  • Impurity assessment, fate and purge studies
  • Fermentation and bioprocessing up to 150,000-liter scale
  • Characterization of API
  • Specification development
  • Regulatory support - pre and post-launch
  • Clinical manufacturing Ph I - III
  • Optimization of cell cultures and lab-based fermentation processes
  • Plant scale fermentation development
  • Complex organic synthesis
  • Milling and micronizing
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The Three Key Ingredients to a Successful API Project & other small molecule API expert content 

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kalamazoo

 

Kalamazoo, Michigan, USA

  • The largest manufacturing site in the Pfizer network
  • Produces approximately 1 million kg of API and 10 million kg of intermediates every year
  • Manufactures antibiotics, hormones and vaccines as well as rare disease and oncology treatment
  • Designated a National Chemical Historic Landmark by the American Chemical Society

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