CMC claim the new facility, supplied with processing equipment under the partnership with Hyclone, will enable early-phase clinical manufacture of biopharmaceuticals, including monoclonal antibodies and other mammalian cell culture-based recombinant proteins.
“Disposable technology offers the advantages of increased flexibility and efficiency,” said Andy Walker, senior director of manufacturing at CMC.
Walker went on to explain that in order to counter risk of cross-contamination, and to eradicate the need to clean or sterilize the facility - an essential procedure for traditional steel tank facilities - the plant has been fitted with a 100L and two 500L single-use bioreactors (SUBs) and disposable mixers.
"Consequently,” he continued, “[the facility] provides a cost-effective strategy for reducing the speed to market for many biologics."
Single-use technology push
Gustavo Mahler, company president, believes demand for costly high-volume stainless steel tanks will wane for some products as process yields grow following advances in protein expression, cell culture and purification techniques.
"We believe this trend will continue to push bioprocessing toward single-use technology," Mahler said.
The staged expansion at CMC’s Seattle site is going ahead to increase production capability, and to cater for the rising demand for cGMP manufacture of biopharmaceuticals. As part of this, the company have invested in a second 3,000 L bioreactor train, matching the existing line.
Furthermore, client demand has prompted the advancement of plans toward build-out of a pre-existing structure which is set to house two 5000L commercial-ready lines.
The company added that the expansion will eventually involve extending the US workforce by over 30 per cent.