Ajinomoto Althea, Inc. Appoints Dr. Lori McDonald As Vice President Of Compliance

Ajinomoto Althea, Inc. (“Althea”), a leading contract development and manufacturing service organization, announced today it is appointing Dr. Lori McDonald as Vice President of Compliance at Althea.  Althea’s contract manufacturing business continues to grow at a rapid rate driven by biotech companies outsourcing aseptic fill and finish parenteral manufacturing for clinical through commercial programs. Althea’s business has grown 25% annually since its acquisition by Ajinomoto in 2013. In 2016 alone, Althea increased its overall new business by 35%. To accommodate this steep growth trajectory, Althea has added a second fill and finish manufacturing shift and grown its headcount by 30%. In addition, the number of commercially approved drugs that Althea manufactures is growing at an unprecedented rate requiring Althea to further invest in its regulatory and quality teams.

To support and lead Althea’s regulatory excellence at this higher growth rate, Dr. McDonald will serve as Vice President of Compliance bringing with her a wealth of expertise and knowledge in the areas of CMC Regulatory Affairs, dossier filing (IND/NDA/ANDA/BLA) preparations, and FDA, EMEA, MHRA inspections. Prior to coming to Althea, Dr. McDonald served as Global Vice President of Quality, Product Supply Biotech, at Bayer Healthcare for 7 years. Prior to Bayer, she held a broad range of positions as Vice President of Global Quality & EHS at MDS Pharma Services, Vice President of Regulatory Affairs at Alder Biopharmaceuticals, and Executive Director and Site Head at Cardinal Health.

J. David Enloe, Jr., President and CEO of Althea states, “Althea continues to maintain an exemplary regulatory track record with agency approvals in numerous countries and now, with an increasing number of our clients’ new drug programs in Phase III and approaching commercial filing, we must further strengthen our expertise and maintain this best-in-class regulatory track record. We are eager to bring Dr. McDonald on-board as she has extensive experience and knowledge around CMC Regulatory and Quality systems. Dr. McDonald brings perspective from both the drug developer side as Vice President of Global Quality at Bayer Healthcare as well as from the viewpoint of a CDMO through her experience at Cardinal Health and MDS Pharma Services.”

About Ajinomoto Althea, Inc.
Althea is a fully integrated, contract development and manufacturing organization located in San Diego, CA 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, complex formulation, product release and ICH-compliant stability testing. Althea’s formulation technology platform includes Crystalomics, a proprietary technology that offers a formulation solution for large molecule products that must be delivered at high concentrations or as sustained release formulations. Althea also has an innovative and proven recombinant protein expression technology called Corynex technology. For more information, visit www.altheaCMO.com.