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.
It all starts with a simple nucleic acid sequence…
From there, Althea's scientists can design a custom quantitative PCR assay that will meet your specific needs. Our extensive expertise in assay development will be applied to design the most robust, specific, and sensitive assay for your product. Additionally, once your assay is developed, Althea will analyze your samples using conditions established during assay development. We thrive on becoming a true development partner by sharing our wealth of know-how and experience in custom quantitative assay design and sample analysis.
Althea recognizes that different projects require different levels of assay development. The needs of the researcher involved in the early stages of drug development are far different from the ones of an investigator generating data for the pre-clinical and clinical phases. For this reason, we provide two levels of assay development that address the varying needs of our partners.
Custom Qualified qPCR Assay
A Qualified qPCR Assay fulfills the scientific and regulatory requirements for pre-clinical development studies as well as clinical trial studies and is intended for long-term use. This level of assay is fully optimized and includes:
Primer/probe design, synthesis, and testing
Establishment of limit of detection (LOD)
Assessment of limit of quantitation (LOQ)
Establishment of quantitative range
Verification of limits with real samples, or DNA spiked with the target to simulate real samples
Assessment of intra-assay precision
Assessment of inter-assay precision with samples encompassing the quantitative range of the assay. Runs are performed on different days by at least two different operators using different ABI Prism®* 7700 or 7900 instruments
Custom Development qPCR Assay
A Development qPCR Assay is designed specifically for work done in the research stage of pharmaceutical development. This type of assay is specific for a given DNA target within a background of complex DNA. It is a well-optimized assay that includes:
Primer/probe design, synthesis, and testing
Establishment of sensitivity and specificity
Generation of standard curve to determine linear range
Assay development report
Establishment of sensitivity and specificity
Generation of standard curve to determine linear range
Assay development report
Once your quantitative PCR assay is developed, Althea will analyze your samples using conditions established during assay development. Contact Althea to discuss your specific needs with a project consultant.
Assay development report
Once your qualified qPCR assay is developed, Althea will analyze your samples using conditions established during assay development. Contact Althea to discuss your specific needs with a project consultant.
*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