The benefits of utilizing single-use systems (SUS) within the biopharmaceutical industry are well documented in the popular press and heralded at many conferences. At a fundamental level, they present exciting and often unprecedented opportunities in terms of increased productivity, the ability to make rapid capacity adjustments, and lower the overall costs of manufacturing. However, what an end user is effectively outsourcing when they choose to include single-use assemblies within a given process step, or as the scope of their implementation broadens to include an entire process, must be considered. Read more.
Integration Of A Single-Use Platform Process Within An Innovative Facility Design
By R. Barry Holtz, Ph.D., President, G-Con Manufacturing, LLC, and Dennis Powers, Director, Integrated Solutions North America, Sartorius Stedim North America, Inc.
With the age of the blockbuster drug passing, the business model for the biopharmaceutical industry is changing. The personalization of medicine, the emergence of biosimilars and biobetters, and the need to provide vaccines globally are just some of the factors forcing biomanufacturers to rethink how future manufacturing capability is implemented. One thing is clear — the traditional manufacturing strategy of building large-scale, purpose-built, capital-intensive facilities is not going to meet the industry’s emerging production and economic requirements. Read more.
Is Your Single-Use System Supplier Disposable?
By John Briggs, ASQ, CQA, Quality Assurance Manager, ASI
During the past six years, single-use systems and devices have emerged as key agents in the biopharmaceutical landscape. Single-use solutions have revolutionized the pharmaceutical and biopharmaceutical industry, due to their effectiveness in reducing the risks of contamination and allowing faster changeovers. These advantages, coupled with the significantly reduced time and costs required to establish a new manufacturing facility, have made single-use systems the products of the future. Read more.