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 offers stability testing services to evaluate drug product and drug substance stability in accordance with ICH Q1A guidelines. To support these activities, Althea offers full analytical method development and qualification, validated stability chambers at all storage conditions, and a Laboratory Information Management System (LIMS) for complete sample and project management.

Stability Capabilities:

ICH Compliant Protocols
Centralized LIMS for Sample Tracking
Analytical Method Development
Long-term Stability Studies
Accelerated Stability Studies

Stability Testing Methods:

Potency
pH and Appearance
SDS-Page
HPLC (SEC, IEX, RP)
Sterility
UV
Endotoxin

Storage Conditions:

ICH Compliant Protocols
Centralized LIMS for Sample Tracking
Analytical Method Development
Long-term Stability Studies
Accelerated Stability Studies




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