Our partner Althea provides custom cGMP formulation, fill/finish, biologics
filling and labeling in a wide range of sizes of vial and syringes. They
have extensive experience working with recombinant proteins, small molecules,
monoclonal antibodies, plasmid DNA and other pharmaceuticals and biologics.
They offer flexible scheduling and fast turnaround times to meet your aggressive
timelines for all your phase I, II, and III clinical requirements.
Althea’s facility has been specifically designed for maximum regulatory compliance
and it includes separate suites dedicated to formulation and vial or syringe
filling under cGMP conditions. By combining technical and regulatory expertise,
state-of-the-art equipment and technology, and strict compliance to regulatory
guidelines, Althea provides the highest quality service.
Vial Filling and Finishing:
• Range of vial sizes: 2 mL vial to 100
mL bottles
• Capacity: 10 to > 50,000 vials
• Semi-automated
or fully automated filling capabilities
Syringe Filling and Finishing:
• Range of syringe sizes: 0.5 mL syringe to 20 mL syringes
• Capacity:
100 to > 50,000 syringes
• Semi-automated or fully automated filling capabilities
Lyophilization and Finishing:
• Chamber accommodates: 2 mL vials to
20 mL bottles
• Lot sizes dependent on vial configuration:
7,320 vials @ 2 mL to 810 bottles @ 20 mL
• Althea can execute pre-developed
cycles to meet your requirements
For more information please visit http://www.altheatech.com/clinical/fillfinish.html and contact us at marketing<at>px-therapeutics.com .
Althea Technologies