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 is located in San Diego, CA and occupies three custom-designed, fully validated facilities. The 30,000 sq. ft. clinical manufacturing facility was completed in 2003 and is designed to accommodate Althea's small-scale cGMP operations. Building two currently houses all of Althea's contract testing services along with administration. Building three is Althea's commercial manufacturing facility, which is segregated into three parts: a warehouse, Biologic Manufacturing, and Fill/Finish for a total of 30,000 sq. ft.Clinical and Commercial Manufacturing Facilities
The manufacturing facilities along with administration occupies approximately 30,000 square feet. The layout consists of dedicated space for cGMP plasmid DNA production, cGMP protein production, and cGMP vial and syringe filling. Regulatory and product segregation features include multiple air-handling systems, unidirectional personnel and material flow, a water for injection (WFI) water purification system, and comprehensive quality systems. In addition, observation windows have been incorporated into the facility design to accommodate audits and inspections without compromising the safety of the product.Highlights of the manufacturing facilities include:
Five fully independent state-of-the-art cGMP production suites
Separate Media Prep, Buffer Prep and Glasswash Support suites
Equipped with separate HEPA air handling systems
ISO 8 / Class 100,000 in gowning area and ISO 7 / Class 10,000 in the production rooms
ISO 5 / Class 100 workstations are located within each of the production suites
Critical manipulations and filtration steps take place under ISO 5 / Class 100 conditions
Facility equipped with new state-of-the-art USP Purified Water, Water For Injection, and Clean Steam systems
Contract Testing Facilities
The GLP testing area, located in building two, is completely segregated from the manufacturing building and operates on a restricted access system allowing entry to testing personnel only. Services performed in this area include Quantitative PCR testing and Multiplex PCR analysis using our proprietary high-throughput technology, eXpress profiling. The testing space includes a separate sample receiving area, and dedicated laboratories for Adventitious Virus Testing and Integration Studies. The flow of materials from sample receipt to PCR analysis has been optimized for unidirectional motion and laboratories are equipped with an exit/entry monitoring system that prevents backtracking and minimizes the risk of cross contamination.
Althea's new facility was custom-designed with the help of industry leading consultants to provide maximum regulatory compliance and the highest level of environmental quality. Please call us at (888) 4-ALTHEA if you would like to schedule an audit.
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