Monday, February 3, 2014

BioProcess International: Efficient, Flexible Facilities for the 21st Century

Today's author's include: Howard L. Levine, President and Principal Consultant, BioProcess Technology Consultants, Inc., Jan Lilja, Commercial Director, KeyPlants AB, Rick Stock, Consultant, BioProcess Technology Consultants, Inc.; Hans Hummel, Business Development Director, KeyPlants AB, and Susan Dana Jones, VP and Senior Consultant, BioProcess Technology Consultants, Inc.

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, flexible, 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 (1,2,3). 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 flexible 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 oftendesigned to produce a single product each or for campaigning just a few products. But a number of trends are converging to create a demand for smaller, more flexible, and cost-effective manufacturing facility options. Those trends include dramatic increases in product titers and yield, advancements and availability of single-use technologies, pressure to reduce health-care costs, a desire (or in some cases requirement) for local production, and increasing focus on personalized medicine for small niche markets.

You can view the full article here. BPI will be joining us February 10-12 for IBC's 2nd Annual Flexible Facilities Conference taking place in February 24-25 in Berkley, CA. To learn more, view our agenda.

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