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Executive Summary

MULTI-USE FACILITIES OFFER BIOTECH FIRMS ECONOMIC ADVANTAGES in solving manufacturing capacity requirements, Invitron Exec VP and Chief Operating Officer William Srigley maintained at a meeting of the International Society of Pharmaceutical Engineers (ISPE) in Bethesda, Md. March 15. Given the expense of a dedicated plant and the uncertainty of capacity requirements for new biotech products, Srigley asserted, building a cell manufacturing plant for one product or even a plant dedicated to one company's products "may not be reasonable." In such instances, he suggested, "multi-use facilities offer an economic way for the industry to accommodate its capacity requirements." Such facilities, Srigley explained, might produce several products for a single company. An alternative that may offer "significant advantages," he suggested, are multi-use facilities manufacturing multiple products for two or more companies. Contract manufacturing, manufacturing consortia and joint ventures are ways of defining relationships between companies utilizing a multi-user plant, Srigley said. The Invitron exec pointed to the difficult challenges biotech industry management is facing in making manufacturing plant commitments in the context of the regulatory, financial, and production-level uncertainties characterizing current biotech product development. "Construction, start-up, validation and operating costs, even for a modest facility," Srigley pointed out, "may total $80 million over a five-year period." At a discount rate of 15%, he noted, "the effective cost over that five-year period will be more than $200 mil." * As a contract manufacturer for other biotech firms, Invitron surprisingly is not concerned with how FDA will handle the use of manufacturing plants for more than one biotech product. Srigley pointed to "acceptance by FDA of the multi-use facility concept" as "critical" to the economics of biotech product development. While FDA is not prohibiting the development of such facilities, Srigley maintained, the regulations as they are currently being interpreted present difficult hurdles. Addressing the issue at the ISPE meeting, Center for Biologics Evaluation and Research (CBER) staffers said that FDA is sensitive to manufacturing costs in evaluating industry approaches. On the other hand, CBER Product Certification Division Director Donald Hill cautioned, validation that a production system is "closed" in a multi-use facility and that cross-contamination will not occur can be "very difficult." How strictly FDA applies current good manufacturing practice requirements (CGMPs) during product development is also an issue with serious economic repercussions to the biotech industry, Srigley maintained, adding that a "better upfront understanding" is needed. By imposing a requirement on industry that clinical supplies be made under full CGMPs, he stated, "the FDA would in essence require manufacturers to lock in their production process at a very early stage in the clinical development program." Industry's current perception that FDA discourages manufacturing process change after clinical trials begin and that this change will substantially add to product approval timelines is leading many companies to forego any significant process development during this timeframe, he asserted. Without a way to integrate clinical development with process development, he warned, "many new products will be introduced to the market at a cost which is unnecessarily high" using processes which are inefficient.

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