Ajinomoto Bio-Pharma Services Introduces AJILITY Fast Track Platform for Drug Product Manufacturing
June 30, 2020 – San Diego, CA – Ajinomoto Bio-Pharma Services (“Aji Bio-Pharma”), a leading provider of biopharmaceutical contract development and manufacturing services, is pleased to announce the launch of AJILITY™, a flexible and agile drug product manufacturing platform, designed to advance vaccines and therapies to market by minimizing time to production.
Aji Bio-Pharma’s AJILITY platform is designed for novel therapeutics/vaccines and existing drug products with a new indication that can be used in COVID-19 trials, FDA Emergency Use Authorizations (EUA), or other programs, providing enhanced flexibility by leveraging our existing, streamlined project configurations. With Aji Bio-Pharma’s AJILITY, clients will have access to our experience and expertise to guide them through decisions from components and excipients to method qualifications. The goal of the AJILITY platform is to minimize variables during tech transfer, manufacturing and shipping processes and rely on our regulatory expertise to navigate traditional production hurdles to quickly get therapies to clinics.
“The AJILITY platform offers flexibility and time savings, which is an enormous boost to those clients with drug products that need to get to clinical trials quickly,” said Dustin Campbell, Associate Director of Commercial Operations at Ajinomoto Bio-Pharma Services. “As a leading CDMO for drug product manufacturing, we understand that some program details affect the manufacturing timeline more than others. The AJILITY platform utilizes Aji Bio-Pharma’s extensive experience in manufacturing and regulatory insight to fast track our clients’ programs to market.”
“We are excited to introduce the AJILITY platform to our client base interested in our progressive partnering approach to advance their therapeutics to patients,” said Kristin DeFife, Ph.D., Sr. VP of Operations & Site Head at Ajinomoto Bio-Pharma Services. “The AJILITY platform was developed by a cross-functional departmental team to provide our clients access to preferred drug product manufacturing processes, coupled with our expertise in regulatory submissions, process development, and shipping configurations at our San Diego, California facility.”
To learn more about the AJILITY program, visit: www.AjiBio-Pharma.com/AJILITY.
À propos d'Ajinomoto Bio-Pharma Services
Ajinomoto Bio-Pharma Services est une organisation de développement et de fabrication sous contrat (CDMO) entièrement intégrée, disposant de sites en Belgique, aux États-Unis, au Japon et en Inde. Elle propose des services complets de développement, de fabrication conforme aux normes cGMP et de conditionnement aseptique pour les principes actifs pharmaceutiques (API) de petite et grande taille ainsi que pour les intermédiaires. Ajinomoto Bio-Pharma Services propose un large éventail de plateformes et de capacités innovantes, allant des programmes précliniques et pilotes jusqu’aux quantités commerciales, notamment la technologie d’expression protéique Corynex®, la synthèse d’oligonucléotides, les conjugués anticorps-médicaments (ADC), les principes actifs pharmaceutiques à haute puissance (HPAPI), la biocatalyse, la fabrication en flux continu et bien plus encore. Ajinomoto Bio-Pharma Services s’engage à fournir un niveau élevé de qualité et de service afin de répondre aux besoins de ses clients. Pour en savoir plus : www.AjiBio-Pharma.com
