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.
At any time during the production process, there is a risk of contamination of product through adventitious introduction of virus. The presence of these contaminating viruses could have serious clinical consequences, and thus it is essential to conduct assays to demonstrate the absence of these adventitious agents in the product. Althea Technologies understands the importance of these assays, and now offers qPCR-based tests for the detection of species-specific viruses and mycoplasma.

Analysis of the cell line and/or product will be performed using the ABI Prism®** 7700 or 7900 Sequence Detection System. Viruses that can be detected include:

Adeno-Associated Virus (AAV)
Parvovirus B19 (Parvo-B19)
Cytomegalovirus (CMV)
Epstein-Barr Virus (EBV)
Hepatitis A Virus (HAV)*
Hepatitis B Virus (HBV)
Hepatitis C Virus (HCV)*
Human Herpes Virus 6 (HHV6)
Human Herpes Virus 7 (HHV7)
Human Herpes Virus 8 (HHV8)
Human Immunodeficiency Virus Type 1 (HIV-1)*
Human Immunodeficiency Virus Type 2 (HIV-2)*
Human T-Cell Leukemia Virus Type 1 (HTLV-1)*
Human T-Cell Leukemia Virus Type 2 (HTLV-2)*
SV40
Mycoplasma

*RNA Viruses

**ABI Prism is a trademark of Applera Corporation



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