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 United Kingdom.
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 been only
a few dedicated conferences in these regions that focus on single-use systems, even though significant implementation in European
vaccine and biopharmaceutical manufacturing facilities has occurred. 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 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, 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 European Medicines Agency 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 (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. Japanese pharmaceutical companies, however, are 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.
