Downstream Factors That Will Continue To Constrain Manufacturing Through 2013

by Eric S. Langer
Volume 8, Issue 4 (Winter 2009/2010)

Downstream processing is increasingly seen to be a capacity constraint for many biopharmaceutical manufacturing organizations. In our current study, nearly 75% of respondents reported that their facilities were experiencing some degree of capacity bottlenecks as a result of downstream processing. In comparison, 63.8% responded the same in the previous year. As the biopharmaceutical industry increases its focus on cost containment, product pricing, and healthcare reform, critical manufacturing operations have been pushed to center stage. Over the past few years, downstream processing, which includes complex operations such as filtration of final products and chromatography operations has become increasingly challenging, from budgetary and operational perspectives. As upstream operations continue to improve, the ability of current downstream facilities to handle the additional load has led to strains and constrictions. The industry is open to new solutions although few alternatives to current processes have been presented. A number of promising innovative technologies are on the horizon, but it will be a few years or more before they debut in clinical or commercial production operations….

Langer ES. Downstream Factors That Will Continue To Constrain Manufacturing Through 2013. BioProcess J, 2009; 8(4): 24-28.