Ajinomoto Althea, Inc. is a fully integrated, contract development and manufacturing organization providing clinical and commercial product development services. Althea offers cGMP drug product filling in both vials and syringes, and production of microbial-derived recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, analytical development, lyophilization cycle, complex formulation, product release and ICH-compliant stability testing. In addition Althea offers a proprietary formulation technology platform, Crystalomics® and an innovative recombinant protein expression technology called Corynex® technology. Althea is the manufacturing partner that delivers the relentless dedication and support our clients need.
Key Services: • Cell Line Development • Process Development • cGMP Protein and DNA Plasmid Production • Analytical Method Development & Validation • Lyophilization Cycle Development • Complex Formulation • 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 ten times by the FDA in 2005, 2008, 2011(2), 2012, 2013 (2) 2015 (3), all of which resulted in no FDA Form 483's being issued, and by over 48 different QPs. To-date, Althea’s cGMP facilities have produced >300 cell banks, >320 cGMP protein & plasmid DNA lots, and >2500 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.