03.12.19
Ajinomoto Bio-Pharma Services, a global provider of bio-pharmaceutical contract development and manufacturing, is expanding its capabilities and capacities. The company has several capital projects currently underway in both the U.S. and Belgium, investing more than $100 million to further expand its offerings and capabilities. In addition to the previously announced highly potent product conjugation and fully isolated fill line, which has recently began operations in its new facility in San Diego, the company 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.
Updates include:
· 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.
· Reconfiguration of GMP manufacturing suites in Belgium to support increased HPAPI capacity and improve process safety with additional instrumentation.
“These investments not only increase our capabilities and capacities at our US and Belgium facilities, they represent a strong step towards achieving our Vision Statement of being a leading, trusted, innovative partner to our customers and to our people. In doing so, we can further contribute to what’s really important to us as a company, that is, improving and extending the lives of patients with the drugs we produce,” said David Enloe, president and chief executive officer of Ajinomoto Bio-Pharma Services .“These capacity expansions ensure that we have the assets and capabilities to meet current and future industry needs. They also ensure we continue to attract the best talent to add to our world class teams.”
Updates include:
· 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.
· Reconfiguration of GMP manufacturing suites in Belgium to support increased HPAPI capacity and improve process safety with additional instrumentation.
“These investments not only increase our capabilities and capacities at our US and Belgium facilities, they represent a strong step towards achieving our Vision Statement of being a leading, trusted, innovative partner to our customers and to our people. In doing so, we can further contribute to what’s really important to us as a company, that is, improving and extending the lives of patients with the drugs we produce,” said David Enloe, president and chief executive officer of Ajinomoto Bio-Pharma Services .“These capacity expansions ensure that we have the assets and capabilities to meet current and future industry needs. They also ensure we continue to attract the best talent to add to our world class teams.”
