Pall, NIBRT co-host master class on single-use systems in manufacturing of biopharmaceuticals

Pall Life Sciences and the National Institute for Bioprocessing Research and Training (NIBRT) in Ireland recently co-hosted a master class on the use of single-use systems in the development and manufacturing of biopharmaceuticals. The event kicked off a new educational series from Pall Corporation (NYSE: PLL) designed to encourage collaboration and best practices among the global community of single-use system users. The next installment in the series is scheduled for Thursday, November 3, 2011 near Swindon in Wiltshire, England.

“As the bioprocessing industry rapidly shifts towards a single-use manufacturing paradigm, the need for sharing experiences and establishing global best practice becomes ever more important”

"As the bioprocessing industry rapidly shifts towards a single-use manufacturing paradigm, the need for sharing experiences and establishing global best practice becomes ever more important," said Yves Baratelli, president, Pall Life Sciences. "The Pall Master Class series provides an educational forum for biopharmaceutical professionals who are involved with, or are considering, the implementation of single-use manufacturing solutions."

More than 50 delegates from across Europe, including emerging markets such as Hungary and Romania, attended the inaugural master class. The class was held at NIBRT's state-of-the-art training and research facility, which was designed to support the deployment of advanced technologies such as single-use manufacturing solutions.

Presentations covered the qualification and validation of single-use systems with an emphasis on the study and measurement of extractables, leachables, particulates, and endotoxins. Insight on a range of case studies was provided by leading authorities in the areas of chemistry and biochemistry. These included Weibing Ding, Ph.D. (chemistry), and Hélène Pora, Ph.D. (biochemistry), from Pall Life Sciences; chemical engineers Peter Rogge and Benjamin Minow from Rentschler Biotech, Germany; and pharmacist Jean-Pascal Zambaux from Disposable-Lab, France. Roundtable discussions focused on the requirements for process specific validation, the challenges of automation and the supplier/end-user relationship.

Topics for the next master class include the following: sterilization by irradiation-processing technology; single-use systems in the contract manufacturing environment; applications within a small- to medium-sized biotechnology company; sterile formulation and filling applications; and academic research and training on single-use systems. There also will be a presentation on regulatory issues entitled: "At inspection, biopharmaceuticals are often not such a special case after all!"