About Althea
Althea Technologies, located in San Diego, CA, is a contract development and manufacturing organization that specializes in cGMP manufacturing, analytical development, aseptic filling into vials & syringes, and protein delivery technology for recombinant protein and parenteral products. In a single location, Althea has the capacity to meet your early-stage and commercial requirements.
Key Services:
- Cell Line Development
- Process Development
- cGMP Protein & DNA Plasmid Production
- Analytical Method Development
- Lyophilization Cycle Development
- Sterile Vial Filling
- Sterile Syringe Filling
Protein Formulation Technology - Crystalomics™
- High Concentration Formulations
- Sustained Release Formulations
- Proven Technology
- Proven cGMP Manufacturability at Scale
Since its founding in 1998, Althea's manufacturing facilities have been inspected by the FDA in 2005, 2008, 2011, all of which resulted in no FDA Form 483's being issued, and by over 24 different QPs. To-date, Althea’s cGMP facilities have produced >250 cell banks, >150 cGMP protein & plasmid DNA lots, and >1,300 cGMP fill & finish lots. Althea has the experience, expertise, capacity, and flexibility to serve as your strategic partner for your drug development and manufacturing needs.
