MARLBOROUGH, Mass., May 25 /PRNewswire/ -- Xcellerex today will receive Frost & Sullivan’s 2005 Technology of the Year Award in Biologics Manufacturing.
“Biologics manufacturing practices play a key role in determining a pharmaceutical company’s success in the global biologics market,” says Frost & Sullivan Senior Research Analyst R.P. Bhaskaran. “Xcellerex has developed and commercialized unique technology poised to improve flexibility, product quality, and regulatory compliance while decreasing costs.”
Xcellerex has emphasized scalability. “Creating material for clinical trials is relatively easy with small single-use systems,” says Xcellerex founder, president, and chief technical officer Parrish Galliher. “If the drug is successful, manufacturing capacity is needed quickly. That’s where we intend to fill the gap. Our stirred-tank version of a single-use mixing system and bioreactor is a scalable, rapid deployment solution to production needs. This provides a much easier transition from clinical quantities to production quantities.”
FlexFactory(TM) -- Integrated manufacturing platform
The Xcellerex disposable stirred tank bioreactor, XDR(TM), and its disposable stirred tank mixing system, XDM(TM), are key components of the Xcellerex FlexFactory(TM) integrated manufacturing platform.
FlexFactory(TM) is an entire turnkey, transportable production line that incorporates the scalable XDM and XDR systems and downstream operations into discrete modular units. It also includes paperless electronic batch records with additional on-line process and GMP (Good Manufacturing Practices) quality/compliance control that catches operator error, providing higher batch success rates. The XDR(TM), XDM(TM), or an entire FlexFactory(TM) production line can be built, operated, and validated entirely at Xcellerex and then transferred to the customer’s facility shell, compressing the overall time to install GMP manufacturing capacity by at least 50%.
“The FlexFactory(TM) Manufacturing Platform has evoked interest from many industry experts,” says Frost & Sullivan’s Bhaskaran, “because it is far less expensive than conventional fixed platforms and because it provides greater manufacturing efficiency with adherence to FDA standards.”
About Frost & Sullivan
Frost & Sullivan, a global growth consulting company, has been partnering with clients to support the development of innovative strategies for more than 40 years. The company’s industry expertise integrates growth consulting, growth partnership services, and corporate management training to identify and develop opportunities. Frost & Sullivan serves an extensive clientele that includes Global 1000 companies, emerging companies, and the investment community, by providing comprehensive industry coverage that reflects a unique global perspective and combines ongoing analysis of markets, technologies, econometrics, and demographics.
About Xcellerex
Xcellerex, Inc. is a biomanufacturing products and contract services company for process development and manufacturing of biopharmaceuticals. The XDR(TM), XDM(TM), and FlexFactory(TM) products are entering the commercialization stage for the biomanufacturing industry. Contract process development services include high throughput process optimization using automated high-speed process development systems (PDMax(TM)), cGMP manufacturing services include yeast and microbial biologics products, and assistance toward preparation for regulatory filings, with mammalian GMP capability in early 2006. The company occupies a 40,000 square foot biomanufacturing and process development facility in Marlborough, Massachusetts.
Contact:
Susan Dexter, Xcellerex, (508) 480-9225 x253, sdexter@xcellerex.com
Xcellerex, Inc.
CONTACT: Susan Dexter of Xcellerex, +1-508-480-9225 x253,sdexter@xcellerex.com
Web site: http://www.xcellerex.com/