Interphex 2006 Coverage
New Facilities: From Groundbreaking to Validation in 24 Months
In the biotech industry, everyone wants to get to market fast. But what if you have to build a manufacturing facility first? At Interphex 2006, Roger Lias, PhD, vice-president of sales and business development at Cytovance Biologics (Oklahoma City, OK, www.cytovance.com), explained how his company did it quickly. In July of this year, the company expects to complete validation of a new cGMP contract manufacturing facility for biopharmaceuticals derived from mammalian cell culture, just 24 months after the original groundbreaking.
One of the most important lessons, said Lias, was to take time upfront for careful pre-design, and to ensure that business and marketing plans drove facility design. "You have to remain relentlessly focused," he said. "Don't compromise, and insist on buy-in." Cytovance decided to build a cGMP facility primarily for pre-clinical through phase II projects, but that wouldn't preclude possible production of low volume phase III or commercial products. As a contract manufacturing site, it also had to be suitable for multi-product operation and support both European and US markets.
Establishing a facility Master Validation Plan early also was invaluable. "That paid off," said Lias. The plan helping by allowing the design team to ensure that parameters could be measured easily and effectively, by making it clear how and when standards would be tested, and by facilitating coordination of the installation qualification process during construction. The plan also shortened the period between receiving the Certificate of Occupancy and completing the validation.
Through good planning, the project has remained "essentially on budget," Lias says. Change-orders to satisfy the debt funding package led to $90,000 in costs in the early design work, but otherwise the project has held to the original $12.5 million plan. The final facility has approximately 44,000 square feet of usable space that is equipped for clinical scale mammalian cell culture (with 100-L and 500-L bioreactor suites) and associated recovery and purification. The site does not include process development or quality control facilities.
Although disposable equipment is often considered advantageous for establishing new manufacturing operations quickly, Lias said the company limited its use of disposables to technologies that the industry considers established. "As a contract manufacturer, we have to avoid unnecessary risks to our customers that could arise from using technologies that have still not gained full acceptance," he said.