CMC Bio unveils disposable biomanufacturing facility
pharmafile | August 26, 2010 | News story | Manufacturing and Production |Â Â CMC Biologics, disposablesÂ
Contract manufacturer CMC Biologics has completed the construction of a new manufacturing facility at its site in Bothell near Seattle which will rely heavily on the use of disposable equipment.
The addition is part of a major expansion of capacity which will add to its ability to accommodate what the company describes as a “growing demand for cGMP manufacture of biopharmaceuticals.”
The multi-purpose facility will cater for early-phase clinical manufacture of biopharmaceuticals, including monoclonal antibodies and other mammalian cell culture-based recombinant proteins, said the firm.
Manufacturing of biologics using disposable plastic equipment rather than the stainless steel alternative has been gaining pace, mainly because it reduces the cost of setting up a facility and removes the need for cleaning, sterilising and validating components between each production run.
Risk of cross-contamination is also reduced, making it easier to switch between products, and making the facility more flexible. This has led to dramatic growth in the market for single-use equipment. Last year, a report by BioPlan Associates indicated that the market for disposables had been growing at 30% a year for the past few years.
“Consequently, it provides a cost-effective strategy for reducing the speed to market for many biologics,” said Andy Walker, CMC Biologics’ senior director of manufacturing.
Hyclone is supplying the processing equipment for the disposable facility, including a 100L and two 500L single-use bioreactors and disposable mixers.
There are some biologic products for which the use of disposables is not feasible, so CMC Biologics said it will continue to offer stainless-steel clinical and commercial cGMP manufacturing at its sites in Bothell in the US and Copenhagen, Denmark
To that end, the company is currently increasing capacity with the addition of a second 3,000L bioreactor train, identical to the existing line at Bothell. Meanwhile, the company said client demand has also prompted it to embark on a programme to build-out an existing structure that will house two further 5000L commercial-ready manufacturing lines.
CMC Biologics has also increased its headcount by more than 30% at Bothell to support the expansion.
Phil Taylor
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