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Work package 4

Fig. 1: WP 4 Partner Participation
Fig. 1: WP 4 Partner Participation (WP Lead Underlined)

Validation, Certification and Marketing Authorisations of Developed Devices and Reagents

Partner IGEA and 3P prepared all relevant approval steps for the new developed devices (electrodes, transfection cuvettes) and reagents (storage and electroporation buffer) to get authorised for investigational use in clinical trial. Records and reports are defined as well as an validation procedure to classify each single transfection component. Additionally, all relevant compatibility tests have been repeated with the GMP grade pilot batch (released by partner AmBTU) to ensure reproducibility of the previous made results. The devices are designed and manufactured in such a way that they will not compromise health or safety of the patient, user or other personnel when applied in the clinical trials according to the appropriate SOPs.

Documents and reports for CE labelling and marketing application will be prepared. In cooperation with the manufacturing companies, a marketing plan is developed to guarantee the exploitation of the generated know-how (partner IGEA).

Figure 2. Device and reagents developed and certified to be used in the clinical trial. A) GMP-grade electroporation buffer; B) GMP-grade SB100X-transposon plasmid mix; C) single-use, sterile microcuvette in triple-package for transplantation; D) microcuvette with gold-plated electrodes in its holder
Figure 2. Device and reagents developed and certified to be used in the clinical trial. A) GMP-grade electroporation buffer; B) GMP-grade SB100X-transposon plasmid mix; C) single-use, sterile microcuvette in triple-package for transplantation; D) microcuvette with gold-plated electrodes in its holder

Partner 3P prepared manufacturing guidelines which describe the raw materials used and product specifications in accordance with the standards set by Good Manufacturing Practices (GMP). Concerning the GMP quality release criteria 3P is in close cooperation with partner AmBTU. Both SMEs keep high expertise in GMP production and its accompanying regulatory requirements and documentations.

Document preparation will be supported by partner UNIGE (Fig.1).

Based on the outcomes of the phase Ia / IIb trial, a transfection kit will be defined and an authorisation for phase II and later phase III clinical trials will be sought (Fig.2).