Integration Of A Single-Use Platform Process Within An Innovative Facility Design

By R. Barry Holtz, PhD, 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 re-think 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.

Single-use technologies have the potential for helping companies execute their developing strategies for flexible manufacturing. The adoption of disposables continues to increase year over year and is already established in many process steps within the industry. The benefits of single-use, such as reduced cleaning and validation, reduced downtime, and reduced equipment footprint, is well recognized and continues to drive the development of new and innovative products. Over the past decade, we have witnessed the progression from disposable encapsulated filters and tubing sets for small scale production to today’s 2000L bioreactors and 2500L single-use mixing systems being implemented in licensed biomanufacturing processes.