News
Cytovance Biologics Launches Process Development Services for Biopharmaceutical Drug Developers
Princeton, NJ
Initial Services Include Cell Culture, Purification and Method Development -
- Prelude to Full Manufacturing Services in 12 Months -
PRINCETON, N.J., Jan. 6 /PRNewswire/ -- Cytovance Biologics Inc., today announced the immediate availability of a comprehensive portfolio of process development services to support biotechnology companies preparing to progress products into clinical development. Services offered include cell culture process development, purification process development, analytical method development and evaluation and optimization of existing production processes. cGMP cell banking capability will be added during the first quarter. These services will be provided at the Cytovance laboratories located at the Presbyterian Health Foundation Research Park in Oklahoma City.
Cytovance was founded to address the growing global need of the biotechnology industry for full-service biomanufacturing capacity at the clinical and early commercial scale. A state-of-the-art, cGMP clinical manufacturing facility is now under construction at the company's Oklahoma site, and primary and secondary manufacturing capabilities will be added to the company's service offering when the new facility is completed in early 2006.
"We know first hand the critical need for integrated planning and support services and quality manufacturing capabilities for clinical stage protein and antibody therapeutics from our own experience as biopharmaceutical drug developers, and we have assembled an expert team now ready to meet those needs," said William Fallon, Cytovance CEO and president. "We are initiating our process development services now to help companies preparing to enter clinical trials to develop robust, scaleable and cost-effective production processes, and we are on schedule to ramp up our cGMP manufacturing services within a year."
The Cytovance process development services will be under the direction of John Lightholder, formerly director of process development at Genzyme, who brings 30 years of experience to his position at Cytovance. Services will include quality and regulatory support and access to other areas of production-related expertise that will be provided by Cytovance as part of an integrated, seamless service, rather than through the traditional route of coordinating separate contractors.
"Cytovance has the experience and resources necessary to make clinical-stage manufacturing and exemplary service easily accessible to small firms without a major cash investment and without having to deal with the complexities of contracting with larger, less flexible providers," said Roger Lias Ph.D., vice president of sales and business development. "We estimate that 75% of small companies need to outsource their process development and cGMP manufacturing, and we are now ready to help them prepare for clinical development in an expeditious and cost-effective manner."
Mr. Fallon and other Cytovance executives will be available at the 23rd annual J.P. Morgan Healthcare Conference in San Francisco next week, and can be reached through the company's corporate offices in Princeton, N.J. During the conference contact Spencer Reynolds, vice president of marketing, at (609) 683-5833 ext. 102 for information on scheduling a meeting with company representatives. More information is also available on the company website at http://www.cytovance.com.
About Cytovance
Cytovance Biologics, Inc. is a biopharmaceutical contract manufacturing company specializing in the production of therapeutic proteins and antibodies from mammalian cell culture. An experienced management team formed the company to address the biotechnology industry's increasing needs for
full-service manufacturing capacity at the clinical and early commercial scale. The company is launching its process development and early stage manufacturing services in its Oklahoma City facilities and will offer full cGMP manufacturing services from a new custom-built facility by early 2006. Cytovance also maintains business offices in Princeton, New Jersey.