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 currently one of the few companies offering a quantitative real-time PCR method to evaluate plasmid DNA vaccine integration into host cell genomic DNA.When a plasmid construct is selected for clinical development, the FDA may require that a study be conducted to confirm that plasmid DNA integration is either absent or at an insignificant level. A key factor in this determination is the limit of detection of the assay used. Althea's qPCR integration assay has the capability to measure down to 5 copies of plasmid DNA per µg of genomic DNA. Due to this sensitivity, and the specificity of an assay that utilizes primers and a probe designed specifically for your plasmid, qPCR is ideally suited to integration studies.
Our scientists will work closely with your research investigator to design a signature assay customized to your specific study needs. Once Althea has received tissue from the site of injection, our scientists will:
Separate high molecular weight genomic DNA from low molecular weight extrachromosomal plasmid DNA
Purify the high molecular weight DNA
Analyze the purified DNA with a custom real-time qPCR assay that utilizes the primers and a probe designed for your specific plasmid DNA product
Conduct study in compliance with GLP if required
Provide a comprehensive integration study report
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