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, III clinical and Commercial requirements. Our Regulatory staff are experienced in the commercial launch of FDA and EMEA products, and can support IND and BLA/MAA relevant sections. We have both a DMF and BMF which may be cross-referenced by our clients
Our facility has been specifically designed for maximum regulatory compliance and it has been inspected twice by the FDA with no 483 observations issued. 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.
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