Ajinomoto Althea, 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.
- 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 (2), 2012 & 2013, and by over 30 different QPs. To-date, Althea’s cGMP facilities have produced >300 cell banks, >160 cGMP protein & plasmid DNA lots, and >1,700 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.