In biopharmaceutical manufacturing today, quality management is critical for steering clear of production problems, capacity bottlenecks, and operation failures. The good news is that manufacturers appear to be doing a better job over the past 10 years.
In our 9th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production , we evaluated, along with more than 80 other biomanufacturing trends, the frequency of batch failures among global biomanufacturers. We weighted information shared by 302 respondents to estimate the batch failure rate for the industry. Based on the responses, batch failures occur on average every 60.3 weeks per facility. This is a significant improvement over last year’s average of 54.5 weeks, and shows a continuing trend over the past five years (Figure 1). Indeed, in 2008, we found batch failures to occur every 40.6 weeks. This means that in five years, the batch failure rate has improved by 49%.
1. 9th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production: A Survey of Biotherapeutic Developers and Contract Manufacturing Organizations, BioPlan Associates. www.bioplanassociates.com
About the Author
Eric S. Langer is president and managing partner at BioPlan Associates, Inc., a biotechnology and life sciences marketing research and publishing firm established in Rockville, MD in 1989. He is editor of numerous studies, including “Biopharmaceutical Technology in China,” “Advances in Large-scale Biopharmaceutical Manufacturing”, and many other industry reports. He can be reached at [email protected].
The 2012 Ninth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production in the series of annual evaluations by BioPlan Associates, Inc. yields a composite view and trend analysis from 302 responsible individuals at biopharmaceutical manufacturers and contract manufacturing organizations (CMOs) in 29 countries. The methodology also included 185 direct suppliers of materials, services and equipment to this industry. This year's survey covers such issues as: new product needs, facility budget changes, current capacity, future capacity constraints, expansions, use of disposables, trends and budgets in disposables, trends in downstream purification, quality management and control, hiring issues, and employment. The quantitative trend analysis provides details and comparisons of production by biotherapeutic developers and CMOs. It also evaluates trends over time, and assesses differences in the world's major markets in the U.S. and Europe.