Emergent BioSolutions has extended its partnership with vendor ABEC and added a dual purpose single-use system at its site in Baltimore, Maryland.
ABEC has shipped a custom designed CSR (Custom Single Run) dual purpose single-use system to Emergent’s Bayview facility, intended for large scale microbial fermentation and mammalian cell culture.
“A CSR dual purpose system can operate as a 750 L production microbial fermenter or as a 500L seed bioreactor for Emergent’s 4,000 L CSR bioreactor,” ABEC spokesperson Susan Cooper-Curcio told BioProcess Insider.
The Bayview facility is one of three in the US designated by the US Department of Health and Human Services (HHS) as a center for innovation in advanced development and manufacturing. Last year, the firm acquired raxibacumab from GSK, and began transferring the manufacturing and fill/finish processes to its Bayview and nearby Camden facilities.
The fully human monoclonal antibody has been approved by the US Food and Drug Administration (FDA) for the treatment and prophylaxis of inhalational anthrax. Emergent took on a multi-year contract with the Biomedical Advanced Research and Development Authority (BARDA) to supply the product to the US Strategic National Stockpile (SNS), valued at up to $130 million.
4,000 L single-use bioreactor
The shipment comes a year after Emergent bought and installed a 4,000 L single-use bioreactor from ABEC. According to the bioprocessing vendor, the bioreactor is the largest available on the market, and twice the size of the 2,000 L systems typically viewed by industry as the upper limit of single-use capacity.
“ABEC’s Custom Single Run systems enhance our clients’ manufacturing productivity, flexibility and economies of scale,” Cooper-Curcio said. “Wuxi, Emergent, and other customers are realizing these benefits.”
In March this year, Chinese contract development and manufacturing organization (CDMO) WuXi Biologics selected the firm’s 4,000 L disposable bioreactors for its commercial manufacturing facility in Wuxi city, Jiangsu, China. The clinical and commercial manufacturing plant is the fourth in the firm’s network and is expected to be operational next year.
The selection of 4 KL disposable bioreactor by Chinese company is a great news for India where there are considerable doubts about the economy of such reactors because of (1) considerable initial costs, (2)reliability of continuous supply on long-term perspective, and (3) associated discharge/destruction/ disposal issues of the disposables.