Wednesday, October 22, 2025 – Main Conference Day 2 - JT (Japan Time, GMT+09:00)
- Jack Wong - CEO and Founder, Asia Regulatory Professionals Association (ARPA)
- Minghua Liu - CMC Consultant, Regulatory Affairs, Eliquent Life Sciences
The Genedata E2E Platform, also known as Genedata Bioprocess®, is designed to unify fragmented digital ecosystems in bioprocess development by integrating data from ELNs, LIMS, and data lakes to streamline decision-making and process analytical technology (PAT) implementation. The platform manages all stages of bioprocessing, including upstream and downstream processing, formulation, and cell line development, enabling organizations to design advanced workflows, select high-yield cell lines, and optimize media and scale-up processes. Additionally, integration with robotics and automation supports high-throughput operations, while built-in data integrity and compliance features ensure product quality, safety, and regulatory readiness.
Genedata Bioprocess® enables structured CMC data capture, efficient analysis, and seamless transfer to regulatory agencies. Supports all biotherapeutic modalities, it provides unique identifiers, genealogy tracking, and robust quality control. Applying automation to data capture, analysis, and reporting accelerates workflows, while AI/ML integration enables advanced analytics and predictive modeling. Real-world applications have demonstrated significant reductions in analysis time and improved data-driven decision-making. This unified approach empowers biopharma organizations to develop innovative biotherapeutics and novel modalities more efficiently, ensuring compliance and fostering rapid innovation.
- Mizue Hisano, PhD - Scientific Business Consultant, Genedata Bioprocess, Genedata
- Niki Wong - Director, Global Technical Operations CMC, AbbVie Operations Singapore Pte Ltd
- Mark Duerkop - Chief Executive Officer, Novasign
- Mrinal Bachute - Head Industry Connect, Associate Professor, Symbiosis Institute of Technology, Symbiosis International University
- Sean Stowe - Principal Solutions Consultant, IDBS
- Maggie Lo - Senior VP, Life and Health Technology, Office for Attracting Strategic Enterprises
- Gang Qin, PhD - President, GeneQuantum Healthcare (Suzhou) Co., Ltd.
- Yuusuke Saito - Engineer, Chugai Pharma manufacturing
Polysorbates are often used in biologics for their stabilization effectiveness. However, the oxidative impurities and related products of polysorbates possess detrimental effect on the stability, potency and activity of the biologics. To overcome these challenges, an alternative with no harmful effects is required. Roquette product is natural in origin (derived from plant-based product). It does not get degrade and does not form impurities that affects the stability, potency and activity of the biologicals and vaccine formulation. Roquette has performed several studies to reconfirm and prove the stability of this product under various stress conditions. Also, the impact on the finished formulation is studied and compared with polysorbates to explain the benefits of this nature-based product. Are you ready to learn about this Interesting Roquette excipient? And make your biological products more stable.
- Lia LV - Pharma Technical Developer, Roquette
- Takashi Kaminagayoshi - Head of Biotherapeutics Process Development - Japan, Takeda Pharmaceutical Company Limited, Japan
- Yuki Abe, Ph.D., - Director, BioPharm Services Ltd.
- Makoto Sadamitsu - Head, Integrated Early Process Development, Biotherapeutics Process Development, Takeda Pharmaceutical Company Limited
- Tomonori Shiotani - Researcher, Chugai Pharmaceutical Co., Ltd.
- Andy Wiranata Wijaya - Bioprocess Development Lead, Nestlé Research
- Christopher Bravery, Ph.D. - Principal Consultant, Consulting on Advanced Biologicals
- Tomomi Sato - Associate Director, Parenteral DP, Drug Product & Device Development, Takeda Pharmaceutical Company Limited
- Xinfang Li - CEO, MabPlex International Co., Ltd.
- Atsushi Inoue, Ph.D. - Biological Technology Lead, Astellas Pharma Inc
- Seishiro Sawamura - Principal Scientist, Digital CMC, Sustainability & Technology, Takeda Pharmaceutical Company Limited
- Osamu Shirokizawa - President and CEO, Life Scientia Ltd.
- Changlin Dou - R&D President, Chief Operating Officer, Executive Board Member, Shandong Boan Biotechnology Co., Ltd, China
- Scott Wheelwright, Ph.D. - Chairman, CTO & Co-Founder, BioChromatographix International Pte. Ltd. (BCI)
- Atsushi Inoue, Ph.D. - Biological Technology Lead, Astellas Pharma Inc