CONCLUSION
Developing a new technology for filling injectable products requires an in-depth validation plan to ensure that such technology
meets all regulatory requirements and provides the necessary features to protect and conserve the product. This article has
shown that the closed-vial technology satisfies all requirements according to regulatory authorities. This article describes
a useful structure of investigation to follow to prove suitability for drug approval when developing a new container (or of
a new part of container).
These data have been well received by the European authorities to support approval of Synflorix, a vaccine from GSK Biologicals
against pneumococcal infections that has been approved in all European countries.
ACKNOWLEDGMENTS
Aseptic Technologies receives grants from the Region Wallonne and from the Agence Wallone à l'Exportation (AWEX). Technology
has been licensed by Medical Instill Technologies.
Benoît Verjans, PhD*, is chief commercial officer, Anne Glibert is in quality control, and Patrick Baleriaux is chief executive officer, all at Aseptic Technologies, Gembloux, Belgium. *To whom correspondence should be addressed, Benoit.verjans@aseptictech.com
.
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