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 Technologies, Inc. is pleased to announce that we are expanding our contract manufacturing and development service offerings by adding additional cGMP and GLP facilities to its San Diego campus. Althea Technologies is now offering Phase III and Commercial-Scale cGMP contract manufacturing services to the biotech and pharmaceutical industries. Althea’s team has expertise in all aspects of biologics and drug product manufacturing, including scale-up and process development scale-up, fermentation, purification, analytical testing, final formulation and product filling.
Althea’s commercial-scale facility has been custom-designed to accommodate cGMP manufacturing services that meet all US, EP and JP guidelines for producing large scale clinical and commercial parenteral material. The new facility is composed of three completely segregated areas for material warehousing, cGMP biologics API production, and cGMP Fill/Finish services. The facility was designed to easily accommodate inspections, audits and “person-in-the-plant” site visits.
Pre-Clinical to Phase I, II, and III, to Commercial Manufacturing
Capacity up to 1000-liter Fermentation
cGMP Plasmid and Protein Production
High-speed Filling Lines for Syringes and Vials (100,000+ units)
ICH Compliant Stability Studies
Capacity up to 1000-liter Fermentation
cGMP Plasmid and Protein Production
High-speed Filling Lines for Syringes and Vials (100,000+ units)
ICH Compliant Stability Studies
For more details click on one of the services below:
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