Xiaolong Xu


Contact info

Xiaolong Xu

Drug Quality and Registration (DruQuaR) group
Ottergemsesteenweg 460, 9000 Ghent (Belgium)

Phone: + 32 (0)9 264.80.94 (secr. 81.01)
Fax: + 32 (0)9 264.81.93
E-mail: Xiaolong.Xu@UGent.be

 Title: The functional quality characterization of starting and raw materials used in te manufacturing of advanced therapy medicinal products (ATMPS)


Advanced therapy medicinal products (ATMP) are associated with high expectations because they offer completely new opportunities for the treatment of diseases, e.g. the possibility of regenerating damaged or lost tissue. However, due to the inherent and/or perceived risks, e.g. transmission of infectious diseases by cell/tissue transplantation, as well as the relative limited clinical experience, pharmaco-vigilance information and regulatory guidance up till now, the development is currently considered as a rather uncertain and difficult -but exciting- road. Irrespective of the regulatory route followed, e.g. as full licensed medicinal product or as unlicensed personalized treatment, one of the main hurdles is the quality of the starting and raw materials used. Research-grade materials are available at an affordable cost, while GMP-grade materials are extremely expensive or even not available at all. Moreover, there are currently no specific quality monographs in pharmacopeia for starting/raw materials used in ATMP production, increasing the difficulty in correctly positioning the level of quality control towards acceptable risks. Turning these research-grade materials into GMP-acceptable materials is thus a real challenge, due to traceability QA issues as well as to lack of appropriate QC tests.

The general goal of this project is to establish a QbD (quality-by-design) approach for QC of starting materials for ATMP as well as to develop some relevant pharmacopoeial monographs for selected starting materials used in the three major classes of ATMP.

Keywords: ATMPs, starting/raw materials, quality characterization