Ajinomoto Bio-Pharma Services provided an update on several of its capital projects currently underway in both the United States and Belgium. These projects total over $100 Million and will further expand Aji Bio-Pharma's offerings and capabilities globally. In addition to the previously announced highly potent product conjugation and fully isolated fill line which has recently commenced operations in its new state of the art facility in San Diego, Aji Bio-Pharma is also adding a new fully isolated, nested flexible fill line, installing automated packaging and labeling equipment, and upgrading its continuous flow and small molecule API manufacturing capabilities. Additional details are as follows:
- The Optima 7000 fill line and upgraded aseptic fill suite have been released for client aseptic filling operations (2ml to 100 ml vials).
- The HPP/ADC fill line (Isolator system) is scheduled to complete its validation activities, and be released for GMP use during the first half of 2019.
- A nested flexible fill line will support a broad range of drug substance APIs, increasing capacity by 50%, enabling larger batch size and a broader range of aseptic filling volumes for vials, syringes and cartridges.
- The addition of the automated packaging and labeling equipment offers serialization and aggregation capabilities to support and comply with Drug Supply Chain Security Act.
- Terminal Sterilization services are now offered for drug product manufacturing projects requiring this step.
- Continuous flow and capability upgrades provide additional capacity and resources to support increased requests for small molecule API manufacturing.
- A new Quality Control lab in Belgium will expand operational capabilities and supports growing demand from our clients.
- Reconfiguration of GMP manufacturing suites in Belgium to support increased HPAPI capacity and improve process safety with additional instrumentation.