CMC Biologics completes first stage of expansion
Adds single-use facility to Seattle plant
CMC Biologics, a contract manufacturing organisation with plants in Europe (Copenhagen, Denmark) and the US (Bothell, WA), has completed a new state-of-the-art disposable manufacturing facility at its Bothell site, near Seattle. The addition is part of a major expansion, which will add significant production capacity to accommodate a growing demand for cGMP manufacture of biopharmaceuticals, the company says.
The multi-purpose, single-use facility will allow for early-phase clinical manufacture of biopharmaceuticals, including monoclonal antibodies and other mammalian cell culture-based recombinant proteins.
Hyclone is supplying the disposable facility with processing equipment, including a 100L and two 500L single-use bioreactors (SUBs) and disposable mixers.
‘Disposable technology offers the advantages of increased flexibility and efficiency, decreased cross-contamination risks, and elimination of cleaning, sterilisation and other changeover procedures typically associated with traditional steel tank facilities, while providing the same performance,’ said Andy Walker, CMC Biologics’ senior director of Manufacturing.
‘Consequently, it provides a cost-effective strategy for reducing the speed to market for many biologics.’
For other products where use of disposables is not feasible, CMC Biologics continues to offer stainless-steel clinical and commercial cGMP manufacturing. The company is currently increasing capacity with the addition of a second 3000L bioreactor train, identical to the existing line.
The company said recent client demand has prompted initial steps in the plan to build-out an existing structure that will house two 5000L commercial-ready manufacturing lines.
CMC Biologics has also increased headcount by more than 30% at Seattle to support the expansion.
