SAN DIEGO, May 25, 2021 /PRNewswire/ -- Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), a leading provider of biopharmaceutical contract development and manufacturing services, today announced it will soon open a high speed multi-purpose fill finish line in its state-of-the-art commercial manufacturing facility located in San Diego, CA.
The new fill line offers a range of configurations, including prefilled syringes, cartridges and vials, utilizing ready-to-use components, which minimize component preparation and packaging. Along with the line, the fill suite houses two formulation suites, one of which is capable of handling flammable (class H) compounds.
The fully contained and integrated OPTIMA line uses SKAN isolated barrier technology to ensure the required sterility for fill finish, while offering flexibility to meet cGMP clinical and commercial drug product manufacturing needs. The high-speed process is rated to move 22,000 syringes per hour through the line, with a batch capacity of over 200 thousand syringes. In addition, it has been designed to meet FDA and EMEA commercial compliance.
"This expansion provides a significant increase in our current aseptic fill/finish capacity and allows for additional scheduling flexibility, as well as component flexibility," says Paul Ruther, Director, Drug Product Manufacturing, Ajinomoto Bio-Pharma Services. "Our continued investment in increasing capacity further enhances Aji Bio-Pharma's commitment in being a leading global and quality-driven CDMO with comprehensive service offerings."
The line will become fully operational in the summer 2021.
About Ajinomoto Bio-Pharma Services
Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India, providing comprehensive development, cGMP manufacturing, and aseptic fill finish services for small and large molecule APIs and intermediates. Ajinomoto Bio-Pharma Services offers a broad range of innovative platforms and capabilities for pre-clinical and pilot programs to commercial quantities, including Corynex® protein expression technology, oligonucleotide synthesis, antibody drug conjugations (ADC), high potency APIs (HPAPI), biocatalysis, continuous flow manufacturing and more. Ajinomoto Bio-Pharma Services is dedicated to providing a high level of quality and service to meet our client's needs. Learn more: www.AjiBio-Pharma.com