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 formulation, 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 have special expertise in performing protein modification, complex formulation and working with un-filterable products. We offer flexible scheduling and fast turnaround times to meet your aggressive timelines for all your commercial products.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 vials to 100 mL bottles
Capacity: up to 100,000+ vials
Semi-automated or fully automated filling capabilities
Syringe Filling:
Range of syringe sizes: 0.5 mL syringes to 20 mL syringes
Capacity: up to 100,000+ syringes
Semi-automated or fully automated filling capabilities
Lyophilization:
Chamber accommodates: 2 mL vials to 50 mL vials
Lot sizes dependent on vial configuration: 7,320 vials @ 2 mL - 810 bottles @ 20 mL
Althea can perform a variety of engineering and tech transfer studies to bring your process to commercial scale cycles and to meet your product 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