Lyophilization

//Lyophilization
Lyophilization2018-01-13T02:38:46+00:00

VxP Pharma’s team of experienced scientists can assist you in all stages of your sterile project, from lyophilization cycle development and optimization to commercial manufacturing of lyophilized products.

Our state-of-the-art formulation suites include some of the best trained and most experienced lyophilization scientists in the field, and the team is backed by vigorous quality systems to provide a seamless collaboration from tech transfer through production for small molecules to biologics.  With the extensive lyophilization capabilities at the facility, as well as the staff, we can work with you to achieve your goals.

Configurations and options:

  • Sizes from 2 mL to 100 mL
  • 13 mm and 20 mm sizes
  • Inert, surface-coated, or standard stopper configurations
  • Flip-off or tear-away seals
  • Qualified and state-of-the-art lyophilizers

Traditional and Complex lyophilized vials:

Manufacturing of Lyophilized Products:

The sterile manufacturing facilities can provide cGMP/CMC clinical scale and research-scale production of lyophilized products within an operational Grade A (ISO 5) environment during processing.  Our large-scale lyophilization chambers can accommodate many thousands (per vial size) and comes integrated with the state-of-the-art, automated filling line for an efficient transition from filled solution to lyophilized product.

CMC and Scale Up Development:

VxP Pharma uses R&D and pilot scale freeze dryers for development projects that are based on robust and cost-efficient lyophilization processes.  The formulation team has experience in screening effective combinations of solvents, buffers, bulking agents, and lyo/cryo-protectants for providing a robust final product these qualities:

  • Low residual moisture/solvent
  • Formation of solid/attractive cake
  • Quick and complete reconstitution
  • Resists physical/chemical degradation

Using lab-scale freeze dryers, the formulation team can develop compounding processes and lyophilization cycles that can be seamlessly transferred from lab-scale to the cGMP production scale freeze dryer for plant-scale operation.
All areas of the aseptic processing facility are routinely monitored for viable and non-viable contamination via airborne and surface methods by the QC Microbiology Laboratory. Additional support is also included by the full service Analytical Chemistry Laboratory and Quality Assurance Department.