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European Biopharmaceutical Review

Keeping It Clean

Advanced therapy medicinal products (ATMPs) are for human use, often in the field of regenerative medicine. They can be stratified into one of the following three categories of product: gene therapy; somatic cell therapy; and tissue engineering and regenerative medicine.

Figures 1 and 2 provide an overview of the distribution of ATMPs currently in development or on the market according to clinical application (1). The sponsors of ATMPs differ widely from the classical, heavily regulated, pharmaceutical market (see Figure 3). Currently, roughly 75% of ATMPs are being developed within the non-commercial sector (universities, hospitals, institutes and so forth) – an aspect that adds unique and significant regulatory challenges when guaranteeing that such products comply with the strict requirements for biological medicinal products.

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Andy Bailey is a virologist who has been actively involved in the pathogen safety of biopharmaceuticals for over 20 years. Originally a biochemist, Andy served for nine years at the MRC virology unit in Glasgow, Scotland. In 1995, he moved as Director of virus validation services to Q-One Biotech, and later to the pathogen safety group of Baxter Healthcare in Vienna, Austria. Since 2005, Andy has been a founder and Chief Executive Officer of ViruSure in Vienna, Austria, a company specialising in virus and prion safety testing of biopharmaceutical products. Over the last 22 years, Andy has presented at numerous regulatory agencies, either in support of products or as an invited speaker at expert workshops.
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