The Single-Use Technology World Tour - Pharmaceutical Technology

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The Single-Use Technology World Tour
Regions around the world are starting to follow the US trend in disposables and are working to solve common challenges.


Pharmaceutical Technology Europe
Volume 23, Issue 6


Jerold Martin
The use of single-use systems has become one of the biggest trends in biopharmaceutical manufacturing since the introduction of complex and sensitive biomolecules, such as monoclonal antibodies and recombinant protein biotherapeutics. In particular, single-use technologies have been widely adopted by global vaccine manufacturers as a means to eliminate cleaning and cleaning validation issues following the influenza vaccine shortage of 2005, which was attributed to contamination issues in a production facility located in the UK.

There has already been much discussion on single-use systems at US conferences and in US publications during the past 10–15 years, but interest is now expanding further across the globe to Europe and Asia. Despite this growth, there have only been a few dedicated conferences in these regions that focus on single-use systems, even though there has been significant implementation in European vaccine and biopharmaceutical manufacturing facilities. However, this trend may be changing. This year, I've been privileged to speak at and chair several international conferences focusing on single use. Such conferences provide an important opportunity for industry participants to share experience, concerns, and best practices.

Europe

On February 1–2, 2011, I visited Brussels (Belgium) to chair the International Quality and Productivity Center's (IQPC) Pharma–IQ Disposables Solutions for Biomanufacturing Conference, which was attended by nearly 100 European manufacturers and suppliers. The conference was Pharma–IQ's third Annual European Disposables meeting. The previous two annual conferences were held in London (UK), and the event is shaping up to be a key European conference for single-use activities. This year's meeting featured speakers from several European-based vaccine, biopharmaceutical and contract manufacturers, including Novartis, Vivalis, Genzyme, CMC Biologics, Cobra Biomanufacturing, Innogenics, Crucell, Eli Lilly, GlaxoSmithKline, Pfizer and Merck Serono, along with supplier presentations from Pall Life Sciences, Sartorius-Stedim Biotech, Novasep, JM Bioconnect, GE Healthcare, and ATMI Life Sciences.

National European regulatory authorities and the EMA have not made public statements about the acceptability or requirements for single-use technologies, but this has not deterred European drug sponsor and contract manufacturing facilities from implementing such systems for both clinical and production batches. Conference topics, for example, focused on everything from comparability of product quality and reduction of carbon footprints to implementation of single-use systems for buffer filling processes and preparation of regulatory submissions. The conference also featured several roundtable discussion sessions that facilitated the sharing of questions and experiences among participants.

Japan

Shortly after Pharma–IQ, I visited Tokyo in Japan (just before the earthquake and tsunami occurred) to give a presentation on single-use technologies and quality requirements at the International Society for Pharmaceutical Engineering (ISPE) Japan Sterile Products Processing Community of Practice meeting. Compared with Europe and the US, implementation of single-use systems in Japan has not been as extensive. However, Japanese pharmaceutical companies are very interested in new applications for single-use technologies. I also met with representatives from Japan's Ministry of Health, Labor and Welfare, who were eager to learn about best practices for implementing single-use systems in biopharmaceutical manufacturing.


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