主题演讲:先进生物制造设施 - 案例研究
加速新模式培养基优化的计算方法
全体会议第1天 - 日本标准时间(GMT+09:00)
全体会议第1天 - 日本标准时间(GMT+09:00)
议长开幕致辞
- Daisuke Kajihara - Senior Director of Bioprocess Technology Research Laboratories, Daiichi Sankyo Co., Ltd., Japan
主题演讲:先进生物制造设施 - 案例研究
This keynote explores the transformative potential of digital innovation and sustainability in shaping the future of biomanufacturing. It examines key considerations for establishing efficient, GMP-compliant facilities at production scale, utilizing novel single-use technologies. The discussion will highlight advancements and emerging trends in biomanufacturing.
- Takashi Kaminagayoshi - Head of Biotherapeutics Process Development - Japan, Takeda Pharmaceutical Company Limited, Japan
案例研究:透过本地生物制造推出新加坡生物技术产品
- A journey of how different team work together to make quick biotech product launch
- Tips on choosing different product classification, regulatory pathway
- Tips on manufacturing setup
- Tips on market expansion
- Jack Wong - CEO and Founder, Asia Regulatory Professionals Association (ARPA), Singapore
适应未来:透过识别表现最佳的克隆来推进生物制程制造并强化制程提高生产力
The need for higher productivity, lower COGs, smaller footprint and more complex molecules is driving bioprocess manufacturing towards process intensification. We demonstrate in two case studies how intensified processes, namely small-scale perfusion mimic and high inoculation fed batch, were incorporated into cell line development. Hereby, not only productivity and titer were significantly increased, but also top clone selection was adjusted to the requirements which cutting-edge production processes impose on a cell line. Aim was to identify clones which are "fit for future" advanced bioprocess manufacturing.
- Christiane Hartmann - Scientist, Operations, Sartorius Stedim Cellca
社交互动用休息时间:包括观看展览和海报的时间
小组讨论: 管理和促进成功的跨国 CDMO 关系
- Setting expectations from the outset to ensure clear communication of timelines
- How can you create trust with both parties to ensure a successful working relationship?
- Key pitfalls and successes
- Choosing the right partners
- Niki Wong - Director, Global Technical Operations CMC, AbbVie, Singapore
- Wei Huang - President, Henlius Biopharmaceutical Ltd, China
- Jay (Jayanta) Sinha - Director, Biologics CMC Development and Manufacturing, Celldex Therapeutics
Celldex Therapeutics的科学性简报
- Jay (Jayanta) Sinha - Director, Biologics CMC Development and Manufacturing, Celldex Therapeutics
使用拉曼光谱进行高效率的批量校准,用于监测 CHO mAb 细胞培养物
The use of Raman spectroscopy as a PAT solution is showing many tremendous opportunities for real time process monitoring capabilities. Historically, the most challenging part of implementing Raman spectroscopy as a PAT solution for real time process monitoring is establishing the chemometric models to monitor the cell culture critical process parameters and critical quality attributes. This chemometric model building process would require multiple batches (4-5) and data points (50-70). During this talk, I will be sharing recent breakthrough of a proprietary and simplified one batch calibration method to easily establish the whole process of chemometric model building
- Minh Tran - Global Head of Automation, PAT and Analytics Software, Merck KGaA
社交互动用休息时间:包括观看展览和海报的时间
议长致辞
GMP 不符合项的根本原因分析和 CAPA 管理
- Regulatory Requirements and Definitions
- Investigation Tools for Root Cause Analysis
- Problem Solving Options for CAPA and Evaluation for Effectiveness Check
- Suggestions for handling Deviations and CAPAs
- Kevin Jonggu Kim - Quality Lead, External Manufacturing Large Molecules, Sanofi, South Korea
生物制品用细胞株的开发
- Yasuhiro Takagi - Senior Director, Astellas Pharma Inc., Japan
细胞株工程(题名未定)
- Changlin Dou - R&D President, Chief Operating Officer, Executive Board Member, Shandong Boan Biotechnology Co., Ltd, China
使用采用制程分析技术的自动化仪器制造人类 MSC 和 iPSC
Critical quality attribute of MSCs is sustained homeostatic replication and those of iPSCs are self-renewal and differentiation susceptibility. Since quality fluctuation of stem cells is primarily caused at culturing, their expansion has long been undertaken by skilled and experienced staffs with large efforts and labors. Simple automatization would not be their solution since process monitoring and analyzing are indispensable to secure quality of unstable stem cells. We have applied CellQualia Intelligent Cell Processing (ICP) System, a fully closed cell manufacturing instrument with process analytical technologies, to both MSCs and iPSCs and compared their quality with those from manual operation. The results showed the quality comparability of the cells from automated and manual expansion. On the other hand, only ICP System enabled us to monitor and record cell manufacturing process as numerical indexes. The data thus obtained is expected to be used in applying Quality-by-Design concept to manufacturing of those cells and base for their in-process qualification. We hope the results of our study would be cue for shifting from manual to automated cell manufacturing at practical level.
- Haruki Takeuchi - Department Manager & Senior Engineer, Medical Engineering Center, Sinfonia Technology Co., Ltd., Japan
社交互动用休息时间:包括观看展览和海报的时间
优化喂料策略,使用基于模型的控制来确保制程稳健性的数位孪生
Cell culture and microbial cultivation processes are complex and difficult to control, because of the biological variability and many process parameters which also interact. The results are batch to batch variations, batch failure and missing economy. However MC process understanding must be demonstrated in regulatory filing, which is currently targeted by many explorative experiments using DoE. This contribution demonstrates the usefulness of process modelling and the deployment of the models as digital twins for process optimization and achieve process robustness. We will show,
- How process models can be set up using a good modelling practice workflow
- How digital twins are used to optimize feeding strategies by model-based design.
- Which data architecture is needed to deploy digital twins in real time?
- How to achieve robustness and optimized process conditions by digital twin-based feedback control?
- Christoph Herwig - Fr. Professor for Biochemical Engineering, Senior Scientific Advisor, Korber Pharma Austria GmbH, Austria
加速新模式培养基优化的计算方法
Culture culture media optimization plays a vital role in bioprocess development. Achieving an optimal formulation for the culture media is crucial as it enables maximum cell growth and subsequently yields the highest possible cell density. The current workflow involves experimental Design of Experiments (DOE) to determine the optimal culture media formulation. A paradigm shift is underway in the optimization of culture media, wherein a modelling approach can be employed to accelerate culture media optimization. In this talk, I will introduce a computational approach involving genome-scale metabolic modelling and model-guided DoE approach, and how this workflow can help the industry, particularly for new modalities, to accelerate culture media design and optimization.
- Zach Pang - Group Leader, A*STAR Bioprocessing Technology Institute, Singapore
社交鸡尾酒会:包括观看展览和海报的时间
* 活动内容有可能不事先告知作更动及调整。