Ajinomoto Bio-Pharma Services Expands Services

Ajinomoto Bio-Pharma Services, a provider of biopharmaceutical contract development and manufacturing, announced several expansions of its capabilities and service offerings in the United States and Belgium totaling more than $100 million, the company announced in a March 12, 2019 press release.

In addition to the previously announced highly potent product conjugation and fully isolated fill line, which has recently started operations in its new facility in San Diego, CA, 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.

The company reports the following updates:

• 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 range of drug substance APIs, increasing capacity by 50%, enabling larger batch size and a larger 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 the 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 demand.

• Reconfiguration of GMP manufacturing suites in Belgium to support increased highly potent API capacity and improve process safety with additional instrumentation.

Source: Ajinomoto Bio-Pharma Services