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Sterile Fill Finish

sterilefillfinish
Our Sterile Manufacturing facility located in Lexington, Kentucky in the USA offers cGMP manufacturing of a wide range of injectable products.  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 22,000 square foot state-of-the-art FDA-inspected sterile manufacturing facility ensures product containment for potent and cytotoxic compounds products while providing an aseptic manufacturing environment.

Product Experience:

  • Suspensions
    • Traditional suspensions
    • Non – aqueous suspensions
    • Liposomal and Nanoparticle suspensions
    • Stable emulsions
  • Biologics – A wide variety of both liquid and lyophilized biologics can be manufactured
    • Dinucleotides and Oligonucleotides
    • Proteins and Peptides
    • Monoclonal Antibodies(mAbs)
    • Antibody Drug Conjugates (ADCs)

Our Services:

  • Process Development & Optimization
  • Parenteral Sterile fill/finish
    • Vials from 2 – 50 mL
    • Dispensing volume as low as 0.5 mL up to 50 mL
  • Parenteral Lyophilization
    • Vials from 2 – 50 mL
  • 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

Site

  • Coldstream, Kentucky, USA