New player on US bioprocessing scene
for business this month, offering a portfolio of process
development services to support biotechnology companies preparing
to progress products into clinical development.
Services offered at the outset include cell culture process development, purification process development, analytical method development and evaluation and optimisation of existing production processes. In addition, current Good Manufacturing Practice (cGMP) standard cell banking capabilities will be added during the first quarter.
According to William Fallon, the company's CEO - who came to Cytovance from Genzyme subsidiary Novazyme - the new company 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 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," said Fallon.
The Cytovance process development services will be under the direction of John Lightholder, formerly director of process development at Genzyme, said that the company's aim was to provide the entire breadth of quality and regulatory support and access to other areas of production-related expertise, rather than through the traditional route of coordinating separate contractors.
Meanwhile, Roger Lias - who joined the firm as vice president of sales and business development in December after holding prior jobs at KBI BioPharma, Diosynth Biotechnology and Lonza Biologics - said Cytovance would be able to make clinical-stage manufacturing accessible to small firms without a major cash investment.
" We estimate that 75 per cent of small companies need to outsource their process development and cGMP manufacturing," he said.
