Interphex 2006 Coverage

Coverage from Interphex 2006

New Facilities: From Groundbreaking to Validation in 24 Months

In the biotech industry, everyone wants to get to market fast. But whatif you have to build a manufacturing facility first? At Interphex 2006,Roger Lias, PhD, vice-president of sales and business development atCytovance Biologics (Oklahoma City, OK, www.cytovance.com), explainedhow his company did it quickly. In July of this year, the companyexpects to complete validation of a new cGMP contract manufacturingfacility for biopharmaceuticals derived from mammalian cellculture, just 24 months after the original groundbreaking.

One of the most important lessons, said Lias, was to take time upfrontfor careful pre-design, and to ensure that business and marketing plansdrove facility design. "You have to remain relentlessly focused," hesaid. "Don't compromise, and insist on buy-in." Cytovance decided tobuild a cGMP facility primarily for pre-clinical through phase IIprojects, but that wouldn't preclude possible production of low volumephase III or commercial products. As a contract manufacturing site, italso had to be suitable for multi-product operation and support bothEuropean and US markets.

Establishing a facility Master Validation Plan early also wasinvaluable. "That paid off," said Lias. The plan helping by allowingthe design team to ensure that parameters could be measured easily andeffectively, by making it clear how and when standards would be tested,and by facilitating coordination of the installation qualificationprocess during construction. The plan also shortened the period betweenreceiving the Certificate of Occupancy and completing the validation.

Through good planning, the project has remained "essentially onbudget," Lias says. Change-orders to satisfy the debt funding packageled to $90,000 in costs in the early design work, but otherwise theproject has held to the original $12.5 million plan. The final facilityhas approximately 44,000 square feet of usable space that is equippedfor clinical scale mammalian cell culture (with 100-L and 500-Lbioreactor suites) and associated recovery and purification. The sitedoes not include process development or quality control facilities.

Although disposable equipment is often considered advantageous forestablishing new manufacturing operations quickly, Lias said thecompany limited its use of disposables to technologies that theindustry considers established. "As a contract manufacturer, we have toavoid unnecessary risks to our customers that could arise from usingtechnologies that have still not gained full acceptance," he said.