Challenges and Solutions in CGT Manufacturing Processes

When:  Jun 27, 2023 from 11:30 to 13:30 (JP)

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Challenges and Solutions in CGT Manufacturing Processes - Integration Between Manufacturing Data and Clinical Data Based Upon Automated Cell Culturing Systems

Presented by the ISCT Asia Regional Executive Committees
Part 2 of the ISCT Asia Webinar Series

Sponsored in part by: 
Hitachi Global Life Solutions, Inc., Vision Care Inc., and Cyto-Facto Inc. 

 

Webinar Description:

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. 


Chaired By: 


Kunihiko Suzuki, MBA
ISCT Asia Regional Treasurer 2021-2023
MEDINET Co., Ltd.
Japan

 











Speakers:

Toshihiro Funatsu
CPC Business Promotion Group Manager
Hitachi Global Life Solutions, Inc. 
Japan

Current Status and Challenges of Manufacturing Ecosystem in Regenerative Medicine

Research and development is active in the regenerative medicine market around the world, and many therapeutic drugs have been launched in Japan. However, it has not yet be industrialized and there are challenges such as stabilizing production and ensuring quality through automation of cell manufacturing and data integrity. In this presentation, we will introduce Hitachi's efforts to solve these issues.

Toshihiro Funatsu is the CPC Business Promotion Group Manager at Hitachi Global Life Solutions, Inc., in Japan. He had obtained his bachelor's degree in Economics from Meijigakun University in 1997 followed by completing the Biomedical Curriculum from Tokyo Women's Medical University in 2019.





















Masayo Takahashi, MD, PhD
President
Vision Care Inc. 
Japan

The Future of Retinal Regenerative Medicine

Our goal is to develop cell and gene therapies for outer retinal layer diseases. First, we performed autologous iPS-derived retinal pigment epithelium (RPE) cell sheet transplantation to demonstrate the safe usage of iPS cells from 2013. The cell sheet works still. In an allogenic transplantation clinical study from 2017. we confirmed that the immune response can be controlled by topical steroids alone if HLA mismatch is avoided, that lead us to the pipeline using HLA partial KO iPS cells. Currently, we expanded our target diseases to RPE impaired diseases and use RPE strips to transplant easily from small holes. To reconstruct outer retinal layer the important challenge is photoreceptor replacement. iPSC-retinal organoid transplantation was conducted last year for two cases of retinitis pigmentosa.

Based on these experiences, we believe that we should create therapies for each category of outer retinal diseases. In addition, since replacement therapies are surgical treatments, there is a gap between the end product and the treatment that does not exist in drug development. Therefore, for an ideal treatment, we need to strictly select the right cases for each therapy and prepare clinical methods such as examinations test and surgical techniques. 

Masayo Takahashi is a Japanese ophthalmologist and stem cell researcher who received her MD, PhD from Kyoto University. After working as a retinal surgeon at Kyoto University Hospital and as a visiting researcher at the Salk Institute in the USA, she joined RIKEN Center for Developmental Biology in Kobe, Japan in 2006. There, she focused on developing new therapies for retinal diseases using stem cells. In 2013, she led the world's first clinical study of induced pluripotent stem cell-based therapy, successfully transplanting retinal cells differentiated from autologous iPSCs into the patient's eye with age-related macular degeneration. She has received numerous awards for her work, including the Commendation for Science and Technology by the Japan Minister of Education, Culture, Sports, Science and Technology. She is a board member of the Japanese Society for Regenerative Medicine and the Japanese Retina and Vitreous Society. In addition to her work on stem cell therapies, she has also been involved in leading the low vision care field through the NPO 'NEXT VISION'. Her contributions to the field of regenerative medicine and patient care have been significant, and she continues to be a leader in ophthalmology and stem cell research.



















Shin Kawamata, MD, PhD
ISCT Asia Regional Secretary 2020-2023
CEO
Cyto-Facto Inc. 
Japan

Introduction of the QbD-based Cell Manufacturing System and its Impact on Cell Manufacturing Service

Cells as starting materials are not uniform in terms of morphology, size and biological potency and final products also show the heterogeneity if they are manufactured with fixed process protocol. Therefore, currently "verification" which requires comprehensive examination of final products is required at every shipment as a practical QA procedure to verify the quality of the products. These situations hinder the industrialization of cell manufacturing business. Here, we show the QbD-based cell manufacturing system that enables to digitalize the process of QC data to make e-Batch record, and link to the internal data such as inventory control, scheduling, staff allocation plan and ERP, and the external data such as supply chain and clinical outcome. These new trends in cell manufacturing will initiate the data handling business in cell manufacturing service is introduced in the seminar.

Shin studied physics in the Faculty of Science at Kyoto University, Japan (1975-1980) and medicine at the Medical School of Kobe University, Japan (1984-1990). Shin started his career as a medical doctor (hematology) and go his PhD degree from Kyoto University (1998). Shin developed various human leukemia modals in SCID mice in his post doctoral period at Systemix Co., Palo Alto, USA and Stanford University (1998-2001). Shin become the Group Leader of Regenerative  Medicine Research Unit and Manger of Cell Processing Facility of The Foundation for Biomedical Research and Innovation (FBRI) (2002-2013) and Director of Cell Therapy Division (2014-present). He is currently the CEO of Cyto-Facto Inc., a CMO/CDMO spinoff company of FBRI. His major research field is stem cell biology and cell manufacturing process. 





































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