Turning Research Into Reality

 

Manufacturing

Our state-of-the-art sterile manufacturing facility provides advanced equipment to meet your manufacturing needs:

 

  • Barrier Technology (Isolators) providing an ISO Class 5 environment during processing, as well as product containment for potent cytotoxic and radiolabelled products

  • Bosch vial filler with capper with a maximum output of 2,000 vials/hour

  • Hull lyophilizer, 48 square feet

  • Steris autoclave, 38 square feet

  • Depyrogenation oven, 48 square feet

  • Two formulation rooms ISO Class 7 (10,000)
  • ISO Class 5 biological safety cabinets in each formulation room

 


Coldstream Laboratories Inc. can efficiently manage small commercial batch manufacturing, as well as supplies for clinical trial studies. Our current batch capacity is:

  • Aseptic Filling - fill rates up to 900 units/hour

  • Freeze Drying (lyophilization) - up to 10,000 units per cycle

  • Gels, Ointment, and Creams - up to 80kg per batch

  • Oral Solution/Suspension - 180L per batch

 


Facility and Utilities

  • 20,000-square-foot manufacturing facility

  • Water for Injection Hot Loop Distribution System
  • Clean Steam Generation and Distribution
  • cGMP Warehouse
  • Building Monitoring System with alarm capabilities
  • Medical Grade Air and Nitrogen Distribution Systems
  • Emergency Power Generator


State-of-the-art cGMP Manufacturing of High Potency and Cytotoxic Compounds


Analytical Services

  • Method Development, Qualification & Validation

  • Raw Material and Drug Product Release Testing

  • ICH Stability Studies


Formulation Development Experience

  • Oral Suspensions ~ Oral Solutions ~ Gels and Creams

  • Ointments ~ Sterile Solutions ~ Sterile Nanoparticles

  • Sterile Microspheres ~ Sterile Liposomes ~Emulsions

  • Lyophilized SVPs ~ Aerosols


Microbiological Services

  • Sterility Testing

  • Endotoxin Testing

  • Container - Closure Integrity

  • Filter Validation