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1 Surname______________ Name ________________registration ID (matricola)_____________ Technologies for regenerative medicine Prof. Manuela T. Raimondi, Prof, Gianfranco B. Fiore Examination date 29.01.2020 -------------------------------------------------------------------------------------------------------------------- EXAM RULES AT A GLANCE 1. The exam duration is 60 minutes. 2. The use of a calculator, or any other electronic device including computerised watches, is forbidden. 3. You may not copy and / or converse. 4. Questions to any teacher during the exam are not allowed. 5. Answers will be evaluated only if given in English. 6. Each answer is worth the indicated score, or part of it, if it is partially correct. 7. If the exercise requires mathematical passages, the points are awarded only if all passages are shown, inside the spaces provided. 8. The proposed grade will be published on the Politecnico “servizi on line” portal. The threshold for a "30 cum Laude" grade is 32.5 points. Any student wishing to reject the grade should do it through the portal, within the publication period. After this deadline, the grade will be automatically consolidated and verbalised. ------------------------------------------------------------------------------------------------------------------------------ 1) List and Describe minimal requirements for the industrial production of PTC under the Good Manufacturing Practice standards (points 5/33) Under GMP standards, there are five minimal requirements for the production of PTCs for use during pre- clinical testing, clinical trials and commercialization. 1) The new PTC must include a strategy for its production process, including the most suitable bioreactor choice, monitoring methods, quantitative analytical tests. 2) The…