Jerold Martin
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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.
