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.
Custom Qualified qPCR and qRT-PCR Assays
Althea offers the development of qualified qPCR and qRT-PCR assays that fulfill scientific and regulatory requirements for clinical trial studies. Assay development and qualification includes:
Primer/probe design, synthesis, and testing. Sequences will be scanned for potential primer-primer or primer-probe interactions, and the potential to form secondary structures. BLAST searches will be conducted to ensure specificity.
Establishment of limit of detection (LOD)
Assessment of limit of quantitation (LOQ)
Establishment of quantitative range
Verification of performance characteristics with real samples, or mock samples spiked with the target sequence
Assessment of intermediate 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.
Qualification of a reference gene or RNA standard for qRT-PCR assays
Generation of assay development/qualification report
Sample Testing
Once your assay has been qualified, Althea will analyze your samples using conditions established during assay development. Althea has extensive experience receiving, processing, and storing clinical specimens and has developed methods to extract nucleic acids from a wide range of clinical sample types including: whole blood, plasma, serum, urine, buccal swabs, throat swabs, and tissue biopsies. Contact Althea to discuss your specific needs with a project consultant.
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