CLINICAL SUPPLY MANUFACTURING

Stella Hill’s Aseptic Sterile Clinical Manufacturing services include formulation, processing, and filling capabilities for Pre-clinical, stability studies, and Clinical for both vial and syringe applications for the Biotech and Pharmaceutical industries, for all regulatory phases.

  • Clinical API’s for many clients are expensive. Stella Hill’s system and practices are designed to minimize losses, ensuring clients the highest maximum yield of finished product possible.
  • Stella Hill’s new state-of-the-art, commercial scale manufacturing facility can accommodate the transfer and scale-up from Phase III Clinical to Commercial manufacturing.

Development

  • Stella Hill specializes in assisting with the development of processes and formulations for difficult products. Our capabilities include filling of various products with equipment designed for low volume aseptic fills. Product types range from simple solutions to more complicated delivery systems containing proteins, oligonucleotides, peptides, liposomes, etc.
  • Stella Hill is highly specialized in developing and filling compounds that have low solubility

Vial Filling

  • Currently Stella Hill fills a wide range of vial sizes: 2 mL, 3 mL, 5 mL, 10 mL and 20 mL. The filling machine is capable of up to 250 mL bottles.

Syringe Filling

  • Our syringe filling and stoppering system utilizes the Becton Dickinson Hypak™ system and our liquid processing capabilities range from volumes less than one liter to over one hundred liters at a variety of fill volumes.
  • Stella Hill fills 0.5 mL, 1.0mL, 2.25 mL, and 3 mL syringes routinely. The filling system can accommodate 5 mL and 10 mL syringe configurations as well.

Lyophilization

  • The clinical freeze dryer can lyophilize batches up to 7,000 vials, depending on the vial size. Filling, loading and unloading of the clinical lyophilizer is done under Class 100 conditions in Stella Hill’s aseptic, clinical manufacturing facility.