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.
The determination of the amount of host cell DNA contamination in plasmid, viral, and protein preparations is a crucial piece of information for researchers and manufacturers alike. To assist you in gathering this valuable data, Althea Technologies offers two quantitative Real-Time PCR-based host cell DNA assays.
Mammalian Host Cell DNA Contamination Assay
Detection of host cell DNA contamination in viral or protein preparations
Assessment of host cell DNA damage using 3 amplicons of different size
Rapid turnaround time of 1 to 2 weeks
High throughput assay performed in 96 well format
High sensitivity – assay typically detects from 1pg of host cell DNA
Wide quantitative range, up to 6 logs
Qualified assay
GLP testing available
Assessment of host cell DNA damage using 3 amplicons of different size
Rapid turnaround time of 1 to 2 weeks
High throughput assay performed in 96 well format
High sensitivity – assay typically detects from 1pg of host cell DNA
Wide quantitative range, up to 6 logs
Qualified assay
GLP testing available
This assay is extremely versatile and can be used to detect contaminating host cell DNA from a wide range of cell lines derived from humans, mice, rats, primates and hamsters. An added plus to this assay is that it provides additional information over and above quantitation by assessing the extent of DNA damage using our unique testing approach. Sample quality is also determined using an exogenous spike test to verify sample is free of PCR inhibitors.
E.Coli Host Cell DNA Contamination Assay
Fully validated assay
Rapid turnaround time of 1 to 2 weeks
High throughput assay performed in 96 well format
Highly sensitive – assay detects down to 1pg of E. coli DNA
Wide quantitative range, up to 5 logs
GLP testing available
Rapid turnaround time of 1 to 2 weeks
High throughput assay performed in 96 well format
Highly sensitive – assay detects down to 1pg of E. coli DNA
Wide quantitative range, up to 5 logs
GLP testing available
The E. coli host cell DNA contamination assay can be used to monitor host cell DNA removal during the manufacturing process and to assess host cell DNA contamination in the final product. In parallel with each assay, sample quality is assessed by an exogenous spike test to verify it is free of PCR inhibitors.
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