Monday, July 27, 2009 - 11:00 AM
S152

5-Year trends in adoption and implementation of disposable bioreactors: A global study of biopharmaceutical manufacturing and capacity

Eric S. Langer, BioPlan Associates, Inc., 2275 Research Blvd, Suite 500, Rockville, MD 20850

This presentation summarizes data on trends in disposables usage and implementation from our sixth annual report and survey of biopharmaceutical manufacturing. BioPlan Associates, Inc. surveyed 446 responsible individuals at biomanufacturers in 35 countries. Single-use systems are used for a wide range of applications including filtration, purification, storage, mixing, processing, and separating biotherapeutics. Disposable devices have become increasingly common in biopharmaceutical manufacturing over the past five years. They offer advantages compared to fixed stainless steel systems in cleaning and validation, and can reduce time required to get a facility commissioned. Single-use systems provide faster change-overs, and reduce shut-down times in production. On the other hand, recurring operational costs with disposable bioreactors, bags and devices can be high.  The rate of usage of disposables increased substantially from 2005-2008.  In the study, we asked respondents, among other issues, which disposable they used at any stage in bioproduction. Topping the list for market adoption was disposable filter cartridges, where usage remained constant at 94.4% over the past year.  Large jumps from 2005 occurred in a number of facilities using disposables.  We will present the 3-year increase in disposable usage for a variety of disposable products, including Membrane adsorbers, which jumped 36.5 percentage points in market penetration (a CAGR of 39.9%), and bioreactor usage which grew at a CAGR of 30.3%. We will also cover mixing systems, pre-assembled tubing sets, buffer containers, and others. We also discuss basis for these trends, and expectations for usage in 2012.


Web Page: bioplanassociates.com/publications/bmcp.htm