The 2013 ISPE Annual Meeting is the pharmaceutical industry's most significant event. Join us November 3 to 6 in Washington, DC, for industry-leading discussions on drug shortages, quality metrics, breakthrough therapies, stratified sampling and more. Hear from an unprecedented number of regulators, shape the future of the industry in high-level executive sessions and build your staff competencies with over 50 topic-focused sessions. Learn more at www.ISPE.org/2013AnnualMeeting.
By Michiel Ultee, Laureate Biopharmaceutical Services
While much has been written about specific applications of single-use technologies (SUT) in biopharmaceutical production, the breadth of their involvement is sometimes overlooked. From the earliest thaws of frozen cells to the final filling of protein-product solutions, SUT are in widespread use.
By Ellen Leinfuss, SVP, Life Sciences, at UL
The FDA's "Case for Quality" initiative calls for companies to recognize the interrelationship between product quality and business decisions, and how to take the steps to address potential risks.
By Tim Russell, TSI Incorporated
A facility monitoring system (FMS) is a process monitoring tool that collects data from sensors, such as optical particle counters, differential pressure sensors, and temperature probes, in real time.
By A. Lennaertz, S. Knowles, J.C. Drugmand, and J. Castillo, ATMI LifeSciences
Wild-type or recombinant viruses used as vaccines and human gene therapy vectors are an important development tool in modern medicine. Some have demonstrated high potential, such as lentivirus, paramyxovirus, and adeno-associated-virus (AAV).
By Todd Keefe, Southwest Airlines Cargo
The ecosystem tied to the movement of medical and pharmaceutical products is complex and highly distributed. Shippers and receivers for these life-saving products are spread out around the country, and there are no centralized routes between them.
By Jodi M. Zobrist and Nicole W. O'Brien, Ph.D., Gallus Biopharmaceuticals, LLC
Recent trends in biomanufacturing technology and the biopharmaceutical market are supporting the increased adoption of single-use (SU) manufacturing systems. On the demand side, the biopharma industry is focusing on niche and rare diseases with smaller patient populations, resulting in the need for smaller, more agile biomanufacturing capacity.