Capabilities

Formatech's cGMP manufacturing services include aseptic fill/finish and support processes to ensure that products are manufactured to the highest standards of quality. Our facility was designed specifically to accommodate both clinical and small-scale commercial fills. This design minimizes product hold-up, ensuring high process yields from even the smallest production runs.

Our Capabilities:

Sterile fill/finish: Cozzoli Automated Fill Line
  • Vials from 2 – 50 mL; custom sizes evaluated upon request
  • Dispensing volume as low as 150 µL up to 50mL
  • Process yields averaging 95%
Lyophilization: Virtis and FTS Lyophilizers
  • Vials from 2 – 50 mL
  • Bulk lyophilization in LyoGuard® trays

Our Services Include:

  • Aseptic liquid and lyophilized dosage units
  • Compounding/Formulation
  • Ultrafiltration/Diafiltration
  • Technology transfer
  • Custom manufacturing of specialized delivery systems
  • Full support services such as microbiological and QC analytical testing
  • ICH conforming stability programs
To request more information on our aseptic fill and finish capabilities, please click here.  
Case Study – Increase Bioavailability

Case Study – Formulation/Dosage Form Change

Case Study – Analytical Development

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