CPhI Online

- Research & Development

Ajinomoto introduces fast track platform for drug product manufacturing

30 Jun 2020

AJILITY is designed to speed novel or existing therapeutics from development to manufacturing and into the clinic.

Ajinomoto Bio-Pharma Services, a provider of biopharmaceutical contract development and manufacturing services, has launched AJILITY, a flexible and agile drug product manufacturing platform, designed to advance vaccines and therapies to market by minimizing time to production.

The CDMO's new 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 using the company's existing, streamlined project configurations.

Clients will receive guidance on decisions regarding elements such as components and excipients to method qualifications, as well as expertise in regulatory submissions, process development, and shipping configurations at the company's San Diego, California facility.

The goal of the AJILITY platform is to minimize variables during tech transfer, manufacturing and shipping processes, thereby navigating traditional production hurdles to get therapies to clinics quickly.

Dustin Campbell, Associate Director of Commercial Operations at Ajinomoto Bio-Pharma Services, advised: "We understand that some program details affect the manufacturing timeline more than others. The AJILITY platform utilizes Aji Bio-Pharma's experience in manufacturing and regulatory insight to fast track our clients' programs to market."