Ajinomoto Althea Bolsters Regulatory Affairs Team

Ajinomoto Althea has appointed Lori McDonald as vice president of compliance to support and lead the company’s regulatory operations as it continues to grow rapidly, driven by biotech companies outsourcing aseptic fill and finish parenteral manufacturing for clinical through commercial programs. Althea says its 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%.

Dr. McDonald brings her 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 joining Althea, Dr. McDonald served as global vice president of quality, product supply biotech at Bayer Healthcare for 7 years.

"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," said J. David Enloe, Jr., president and chief executive officer, Althea. "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."