Efficient , Flexible Facilities for the 21 st Century

A number of recent improvements in the engineering of high-titer expression vectors, in biopharmaceutical process development, and in facility construction have converged to present new opportunities for cost-effective, f lexible, biomanufacturing facility construction. The evolution of requirements for biopharmaceutical facilities is driven by globalization of the biopharmaceutical industry, patent expirations of several blockbuster biopharmaceutical products, and the increasing shift in new product development away from blockbuster drugs and toward more personalized, niche products. An increase in product approvals (primarily monoclonal antibodies, MAbs) and sales growth of 10% per year for the past five years have transformed the biopharmaceutical industry almost exclusively into a “monoclonal antibody industry.” MAb-related products now represent a significant portion of all biopharmaceuticals approved to date and are anticipated to continue to drive future demand for biopharmaceutical manufacturing capacity (1–3). Further, as many early MAb products come off patent, the competition to develop and market biosimilar versions of those products is rapidly increasing (4). Not only are biosimilar sales expected to grow in the US and European markets, but increasing demand for access to affordable biologic products in the emerging markets of Brazil, Russia, India, and China (BRIC) will also stimulate further growth in such sales. Coupled with a desire for local production of critical medicines, the anticipated sales growth will lead to increasing demand for manufacturing facilities that can be installed and operated within those countries. So the need is clear for relatively simple but f lexible biomanufacturing facilities that can be easily replicated in multiple locations. Like all other biopharmaceutical products, MAbs traditionally have been manufactured in large facilities with multiple fixed, stainless steel bioreactors ranging in size from 100 L to 20,000 L; fixed and inflexible downstream processing space; and complex piping for delivery of buffers and media, product transport, and cleaning of the large number of fixed stainless steel tanks and other equipment. Such facilities were often