Ajinomoto Bio-Pharma Services, a provider of biopharmaceutical contract development and manufacturing services, has announced it will soon open a high-speed multi-purpose fill-finish line in its 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 minimise 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, the line 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," said 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 summer 2021.