Manufacturing Processes – Integration Between Manufacturing Data and Clinical Data Based Upon Automated Cell Culturing Systems

Description

Automated CGT manufacturing process using Hitachi, Vision Care and Cyto-Facto

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Automated CGT manufacturing process will provide the potential solutions to reduce cost and burden in data management/integration on both manufacturing data and clinical data. There are 3 stories on such topics as the up-to-date/practical cases by 1) Hitachi – Decentralized Manufacturing Module/Value Chain Control, 2) Vision Care – Automated Manufacturing Process-Manufacturing Systems, and 3) Cyto-Facto – Automated Manufacturing Process based upon Quality by Design (QbD) initiatives. It is highly valuable to hear such stories and to introduce their activities into your manufacturing process, which will contribute to the successful business practice in CGT product development and commercialization. Key learning objectives: For manufacturing CGT products both in clinical trial phases for Market Authorization, integration of manufacturing related data and clinical related data is one of the key challenges to reach to the goal. In addition, for the commercial phases after obtaining MA, commercial operation with such products requires various data management to meet the regulatory requirement such as GMP, GVP, GPSP and so on. There is limited discussion on such topics in the past and it is significantly important to learn the practical approaches and challenges from these three Japanese Companies in the CGT space.

Open Access 2023 Webinar: Challenges and Solutions in CGT Manufacturing Processes – Integration Between Manufacturing Data and Clinical Data Based Upon Automated Cell Culturing Systems