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 manufactures high quality plasmid DNA designed to meet stringent regulatory requirements. We apply our extensive experience in development and manufacturing to provide complete and consistent manufacturing services. Althea's state-of-the-art cGMP facilities have been custom designed for optimal personnel flow, product flow, and regulatory compliance. Using our proprietary technology, we are able to produce plasmid DNA from milligram to multi-gram quantities for use in preclinical studies through commercialization.Advantages of contracting with Althea Technologies:
Biologics Master File for cGMP plasmid production submitted to FDA
Full USP testing on all incoming raw materials and no animal derived products used at any point in the process (during fermentation or purification)
Licensed by the FDB (State of California)
Proprietary purification procedure specifically designed for scale up
Services provided:
Host strain selection and optimization
cGMP Master Cell Bank and Manufacturers Working Cell Bank production and characterization
Fermentation and purification development and optimization
Product formulation and fill/finish services
Complete QC testing and Certificate of Analysis with each lot
Highest quality plasmid DNA:
Low endotoxin
Low residual host cell DNA
Low residual RNA
Low residual solvents
Undetectable residual protein
Predominantly supercoiled plasmid
Suitable for preclinical or human clinical trials
Low residual host cell DNA
Low residual RNA
Low residual solvents
Undetectable residual protein
Predominantly supercoiled plasmid
Suitable for preclinical or human clinical trials
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