Contract Manufacturing

PaizaBio is somewhat unique among CMOs in that our strategic partner, AUSIA BioTech, operates a Freeze Drying Cycle Research and Development Laboratory that can perform lyophilization optimization services normally available only in an academic environment or a third-party specialty lab.

AUSIA BioTech has recently invested in a sophisticated lyophilization development capability sourced from Germany. It enables us to optimize freeze drying cycles, thereby accelerating production, improving quality and consistency, and minimizing cost. This in-house service helps ensure repeatability of the full manufacturing process, resulting in lower costs and faster turnarounds.

PaizaBio offers high capacity lyophilization services with superior product stability and improved shelf life. We can develop new processes or transfer and adapt existing lyophilization cycles to our equipment, thus ensuring product specifications are met. We offer lyophilization for a broad range of pharmaceuticals, focusing on:

  • Cycle development and optimization
  • Cycle validation
  • Risk control
  • Innovation in freeze-drying technologies

We can accommodate high volume demand with sophisticated and efficient equipment and processes that include:

  • 18 lyophilizers from 20m2 to 45m2
  • Capacity dependent on vial diameter
  • 22mm(7ml/10ml): 2250 vials/m2
  • 13mm(2ml): 4450 vials/m2
  • Automatic loading and unloading system that connects filling, freeze-drying and capping operations
  • Batch sizes up to XX units based on vial size

Quality assurance is ongoing to meet client standards and cFDA regulations and include:

  • Real time digital and visual monitoring via our BAO-Gong® Management Execution System
  • Analytical testing of filled products
  • Semi-annual recertification of HEPA filters
  • Annual smoke studies in Grade A/B area

As you expand your product portfolio in the burgeoning Asian market, we can design and improve lyophilization processes, enhance product stability, extend shelf life, and reduce overall costs for you. Start a conversation about your project. Contact Us.