Aseptic Manufacturing

Coldstream Laboratories is your outsourcing partner for aseptic and non-aseptic drug product manufacturing services. We combine individualized service with unparalleled speed and flexibility to manufacture parenteral drug products in liquid and lyophilized dosage forms. Unique mobile isolator technology within our FDA-approved sterile manufacturing facility ensures product containment for potent and cytotoxic compounds and radiolabeled products.

Drug Product Manufacturing Services:

  • Liquid and Lyophilized Parenterals
  • Process Development & Optimization
  • Terminal Sterilization
  • Pilot Scale Manufacturing: Aseptic and Non-Aseptic
  • Pre-Clinical to Phase III Manufacturing for:
    • Animal Safety/Toxicity Studies
    • Human Clinical Products
    • Veterinary Products
  • Niche Commercial Products
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