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 Aji Bio-Pharma’s existing, streamlined project configurations. With Aji Ajility, clients will have access to the company’s 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 for 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 therapeutic 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."