The Optima VFVM 7000 aseptic fill finish line will be installed in the contract manufacturing organisation’s (CMO) Building 3 facility at its site in San Diego, California and will be operational in Q2 2018, spokeswoman Kristi Gines told this publication.
The installation will be used for customers’ biologic, vaccine, and small molecule fill/finish projects, and comes as a response to concerns regarding the costs of active pharmaceutical ingredients (APIs).
“A key driver for this project was the ability to maximize yield from the filling line as all of our clients are concerned with the cost of manufacturing API,” she said.
She added the new line will offer a number of features and benefits to its clients:
“This line has the capability to use two different pumping systems, rotary piston and peristaltic. The ability to use single use disposable filling assemblies in conjunction with peristaltic pumps is a key feature,” she said.
The line will also have a wide range of vial sizes, from 2mL up to 100mL, and will include nitrogen flushing and an increased batch size.
“This line has features to minimize drug product loss including start and end of production modes, specialised filling mode for larger volume products – 20 mL to 100 mL – and 100% in process control.”
The expansion is the latest for the company, formed in 2013 when Tokyo-based chemical company Ajinomoto bought US CMO Althea for $175m, including its biopharmaceutical production capabilities for microbial-derived recombinant proteins and plasmid DNA, upstream and downstream process development, analytical development, lyophilisation cycle, complex formulation, product release, ICH stability testing and cGMP vial and syringe filling.
A 57,000 sq ft facility offering outsourced ADC (antibody drug conjugate) and HPAPI (highly potent active pharmaceutical ingredient) manufacturing recently opened at the San Diego site.