Commercializing Biotechnology in Early-Stage Ventures.
Introduction:
Ajinomoto Althea, Inc. is a drug manufacturing and contract development organization that provides clinical drug manufacturing and process development services to various global pharmaceutical and biotechnology firms. The company claims to be capable of fully supporting early stages clinical requirements via commercial manufacturing.
History and Background Information:
Althea Inc. was founded in 1998 by Francois Ferre, Ph.D. and Magda Marquet, Ph.D. and its first products were gene quantification assays and plasmids kits. The company delved into manufacturing microbial biologics in 2000, and by 2003, the company was now offering finish and fill manufacturing services to meet client demands. In 2008, due to scale-up capabilities and campus enhancements, Althea landed its first commercial client. In 2009, the company acquired WindRose Analytica becoming a fully integrated Contract Manufacturing Organization (CMO) offering analytical development services. In 2010, Althea acquired Altus Pharmaceuticals’ Crystalomics for its proprietary protein crystallization technology. In 2011, Althea had its first FDA Pre-Approval Inspection, which validated Althea’s position as a large-scale commercial manufacturer (Althea.com, 2016b).
However, in 2013, global Japanese pharmaceutical, processed food, specialty chemicals, amino acid, and beverage manufacturer acquired Althea Technologies for $175 million, and this provided them with access to the trademarked Corynex Protein Expression System, and also enabled Ajinomoto expand its biopharmaceutical manufacturing business into the United States by combining Ajinomoto’s biotechnology experience with Althea’s expertise in cGMP (Current Good Manufacturing Practice) manufacturing, experienced personnel and sophisticated technology. The company has its current headquarters and manufacturing facilities in San Diego, California, and more information can be found on the company website http://altheacmo.com/ (Althea.com, 2016b).
The company does not have public employee records, but it does have a 6-member executive board headed by President and CEO J. David Enloe Jr. Others members include Martha J. Demski who is Senior Vice President (VP) and Chief Financial Officer (CFO), Chris Duffy the Senior VP Operations; Kristin Defife (PhD) the VP biologics, Elaine Sapinoso the VP Regulatory and Quality Affairs; and Jenifer Cannon (PhD) who is senior director of commercial strategy (Althea.com, 2016c).
Products, Services and Partnerships:
Ajinomoto Althea Inc. has partnered and collaborated with numerous clients ranging from small to large scale biopharmaceuticals, universities and government agencies both locally and internationally. The company has also worked on numerous projects ranging from production of plasmid DNAs, recombinant proteins, antibody fragments, vaccines to filling and finishing injectable monoclonal antibodies oligonucleotides, peptides, and small molecules. The company also offers comprehensive services which include analytical development, complex formulations, ICH-compliant stability testing, downstream and upstream process development, lyophilization cycles, and product releases (Althea.com, 2016d).
According to the company website, Althea has produced over 140 purified plasmid DNA bulk lots, 180 purified protein bulk lots, 300 cell banks, and over 2500 filling and finishing bulk lots. The company also has a superb track record in terms of compliance with global regulatory authorities such as the EMA (European Medicines Agency), the Food and Drug Administration (FDA) in the US, RP in Germany, and PMDA (Pharmaceuticals and Medical Devices Agency) in Japan. In this regard, the company has completed 5 desk-based and 5 onsite (10 in total) drug approval inspections in the EU, US, Taiwan, Japan and Canada which only indicates that the company’s drug manufacturing processes, quality control testing and the overall maintenance of quality in all systems complies with Good Manufacturing Practice requirements for all the production filling lines. In this case, the company considers all its procedures and policies to be in compliance with FDA guidelines and the equivalent cGMP standards in Europe (Althea.com, 2016d).
Currently, the target market for Althea is governments and large biopharmaceuticals, and specific details of these partnerships are unavailable in the public domain due to the nature of products, services, and clients. However, it should be noted that Althea does help biopharmaceutical companies take drugs from the early discovery stages, through testing, and all the way to the market. There are risks with product quality control and assurance, but Althea has made a name for itself in cGMP manufacturing which makes it less prone to regulatory and administrative hurdles imposed by both local and international regulatory agencies such as the FDA in the US, and EMA in Europe. The company’s future success relies heavily on how well it continues its good innovative and quality run, as well as how well it handles competition from firms such as Emergent bio-solutions, Albany Molecular Research Incorporated, and PPD (Pharmaceutical Product Development) LLC among others (Hoovers.com, 2016).
Public Information and Milestones Achieved.
Most of the public information and press releases made by the company involve its product and service offerings, acquisition by Ajinomoto, patents, certifications, and projects such as building a $15 million biologics manufacturing facility in the heart of San Diego, California (Keshavan, 2016e; Keshavan, 2016). The press release articles can be found on the “PRESS” tab on the company’s website. Some of the milestones achieved by the company are listed in Table 1 below.
References:
Althea.com. (2016a). Awards - Althea. Althea. Retrieved 18 May 2016, from http://altheacmo.com/about/awards/
Althea.com. (2016b). Company Profile & History - Althea. Althea. Retrieved 16 May 2016, from http://altheacmo.com/about/company-profile-history/
Althea.com. (2016c). Leadership - Althea. Althea. Retrieved 16 May 2016, from http://altheacmo.com/about/leadership/
Althea.com. (2016d). List of Services - Althea. Althea. Retrieved 19 May 2016, from http://altheacmo.com/list-of-services/
Althea.com. (2016e). Press Archive - Althea. Althea. Retrieved 20 May 2016, from http://altheacmo.com/press/
Hoovers.com. (2016). Althea Ajinomoto Inc. Competition. Hoovers.com. Retrieved 20 May 2016, from http://www.hoovers.com/company-information/cs/competition.Althea_Ajinomoto_Inc.3ee6a22fa2acfe14.html
Keshavan, M. (2016). Ajinomoto Completes $175M Purchase of Althea Technologies | San Diego Business Journal. San Diego Business Journal (SDBJ). Retrieved 19 May 2016, from http://sdbj.com/news/2013/apr/10/ajinomoto-completes-175m-purchase-althea-technolog/
