Althea offers cGMP plasmid production, protein production, formulation and filling services. Plasmid DNA and protein production are offered using both Althea’s industry-leading manufacturing process as well as client developed processes. A range of options are available for formulation and filling services ranging from semi- automated to fully- automated processes for vials and syringes. Althea is focused on offering highly responsive customer service, flexible scheduling, and rapid turnaround times to meet the requirements of both early stage clinical programs and commercial programs alike.
Althea provides custom cGMP formulation, fill/finish, biologics filling and labeling in a wide range of sizes of vial and syringes. We have extensive experience working with recombinant proteins, small molecules, monoclonal antibodies, plasmid DNA and other pharmaceuticals and biologics. We offer flexible scheduling and fast turnaround times to meet your aggressive timelines for all your phase I, II, and III clinical requirements.Our 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 our technical and regulatory expertise, our state-of-the-art equipment and technology, and our 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
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
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
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
Althea Technologies
A leading provider of contract services to
the pharmaceutical and biotechnology industries
11040 Roselle Street | San Diego, CA 92121-1205
Toll-free 1-888-4ALTHEA
info@altheatech.com