We partner with our clients to advance their innovative product pipelines in a confident, collaborative, and compliant manner. We are committed to providing our employees with an environment that fosters personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.
Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies. Althea has the capacity to support early-stage clinical requirements through commercial manufacturing.
Althea is a leading expert in aseptic filling of drug product in vials and syringes, and our focused expertise and capabilities make us one of the industry’s top leaders for cGMP microbial-based manufacturing of recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive services including: upstream and downstream process development, complex formulations, lyophilization cycle, analytical development, product release and ICH-compliant stability testing.
Located in San Diego, CA, Althea is a fully owned subsidiary of Ajinomoto Co., a global manufacturer of high-quality seasonings, processed foods, beverages, amino acids, pharmaceuticals and specialty chemicals. Ajinomoto acquired Althea to expand the business for biopharmaceuticals manufacturing in the U.S. market by combining Ajinomoto’s experience in biotechnology with Althea’s sophisticated technology, experienced personnel, and expertise in cGMP manufacturing.
Our cGMP facilities have produced over 300 cell banks, 180 bulk purified protein lots, 140 bulk purified plasmid DNA lots and 2,500 fill & finish lots. Althea has an excellent track record with global regulatory agencies, including the FDA, EMA, PMDA (Japan), and RP (Germany). We have successfully completed 13 drug approval inspections (6 onsite/ 3 desk/ 4 waived) covering applications in the US, EU, Japan, Taiwan, Brazil and Canada indicating our drug product manufacturing processes, quality control testing and overall quality systems are in compliance with GMP requirements for all commercial filling lines. Our processes and procedures are in compliance with European cGMP standards and FDA guidelines.
Our expertise and extensive knowledge of international requirements help assure your product will meet the highest possible quality standards. Our goal is to deliver quality product and personalized service, while providing flexibility and guidance to help our clients achieve their goals in a timely and efficient, cost-effective manner.
Please visit Ajinomoto.com to learn more about our parent company.
Althea Technologies was founded by Magda Marquet, Ph.D. and Francois Ferre, Ph.D. in 1998 and began by developing plasmid kits and gene quantification assays. In 2000, it further expanded into microbial biologics manufacturing. In 2003, Althea began offering fill and finish manufacturing to meet the growing demands of its clients. Campus enhancements and scale up capabilities permitted Althea to sign its first commercial client in 2008. Althea acquired WindRose Analytica in 2009 and became a fully integrated CMO offering our clients Analytical Development Services.
Althea enhanced its service offering by acquiring Altus Pharmaceuticals’ Crystalomics® protein crystallization technology in 2010.Althea had a successful PAI in 2011, which validated the company as a large scale commercial manufacturing facility.
In 2013, Althea Technologies Inc. was acquired by global Japanese manufacturer, Ajinomoto Co. which provided access to the new proprietary Corynex Protein Expression System.
Althea has partnered with many different clients ranging from small to large biopharmaceutical companies, government agencies, and universities, on both a local and international scale. Althea has worked on thousands of projects varying from the production of recombinant proteins, plasmid DNAs, vaccines, antibody fragments, to the fill and finish of injectable peptides, monoclonal antibodies, oligonucleotides, and small molecules.
|2014||Inspected and certified by the EMA|
Received NINTEI certification
|2013||Acquired by Ajinomoto Co.|
Transferred in Corynex® technology to Althea
Appointed J. David Enloe Jr. as CEO
|2011||Successful PAI inspection of large scale commercial facility|
|2010||Acquired Altus Pharmaceuticals’ “Crystalomics® Protein Crystalization Technology”|
|2009||Acquired WindRose Analytica to broaden into analytical services|
|2003||Expanded facilities to include Aseptic Fill Finish Manufacturing|
|2000||Began cGMP microbial biologics manufacturing|
|1998||Founded by Magda Marquet, Ph.D. and Francois Ferre, Ph.D.|
Developed plasmid kits and Gene Quantification