AGENDA AT GLANCE
AGENDA AT GLANCE
8:50
IMAPAC Opening Remarks
8:55
Chairman Opening Remarks
👤 Devi B. Basnet, Senior Research Scientist, Medytox, South Korea
👤 Jaesuk Lee, Chief Scientific Officer, nSAGE, South Korea
Leadership Panel Discussion: Current And Future State of The South Korea Biologics Manufacturing Market & Cell and Gene Therapy in East Asia: A Strategic Overview
Premier Ballroom A
9:00
Leadership Panel Discussion: Biologics & Advanced Therapies in South Korea & East Asia: A Strategic Overview
- Leveraging East Asia’s innovation hubs to accelerate biologics and cell & gene therapy development and commercialization.
- Overcoming region-specific supply chain and manufacturing challenges across biologics and advanced therapies.
- Unlocking opportunities for cross-border collaboration in research, clinical trials, and patient access.
Moderator:
👤 Bryan Choi, Professor, Inha University, Korea
Panellists:
👤 Ryu Kang, CSO, Vaxcell-Bio, Korea
👤 Kenji Nakamaru, VP, Head of R&D, Optieum Biotechnologies, Japan
👤 Phil Huang, Technical Director, Stemcyte, Taiwan
9:50
Advantages of Non-Glucose Carbohydrate Feeding of CHO Cell Cultures
- Impact of different cell culture fluids on the quality of recombinant proteins in CHO cells.
- Common changes made in cell culture to improve growth, viability, metabolism, and productivity.
- Why non-glucose feeds are being explored and how they can benefit cell growth and protein production.
- Results and conclusions from experiments on non-glucose feeds and their impact on CHO cell performance and protein quality.
👤 Hemasunder Reddy, Director, APAC, Pfanstiehl, Singapore
10:15
Path to Commercial Development of Cell and Gene Therapies in East Asia: Regulatory Landscape and Cross-border Collaboration.
- Recent trends in commercial development of cell and gene therapies in Asia
- Regulatory frameworks in Asia to increase patients' access
- Research infrastructure and collaboration on cell and gene therapies in Korea
👤 Bryan Choi, ISCT Asia Regional Vice-President and Professor, Inha University, South Korea
10:40
Morning Tea Break, Exhibition Viewing & 1-1 Attendee Networking
Exhibition Hall, Ballroom B
Upstream Processing: Optimizing Cell Culture and Yield for Next-Generation Therapies
Premier Ballroom A
11:15
Application of Hyperactive Leap-in Transposase in the Multi Cell Line Development Platform
- Reliable and enhanced productivity in proprietary GS knock out cell line.
- Consistent performance of afucosylated cell line with enhanced ADCC activity.
- Application of transposase technology for early material generation.
👤 Wooyoung Chi, Director, Cell Line Development, Samsung Biologics, South Korea
11:40
Best Practices in Host Cell Impurity Analytics – Using Advanced Technologies and Methods to Monitor, Control and Quantify Host Cell Proteins
- Evolution of HCP analytics from early semi-quantitative “black box” methods to advanced Mass Spectrometry enabling identification of every host cell protein in a drug substance.
- Current capabilities of HCP ELISA: no longer a black box, with clear understanding of which HCPs are detected or missed.
- Importance of integrating advanced technologies to ensure ELISA assays (generic or process-specific) are fit for purpose and support data-driven risk assessment for drug safety and integrity.
- Case study: Cygnus CHO Lipase Assay using stable isotope-labeled peptides and PRM-MS absolute quantification.
👤 John Locklear, Associate Director, Assay Development and Technical Support, Cygnus Technologies, United States
12:05
Development of Real-Time Bioprocess Monitoring & Prediction System with Raman Spectroscopy during Upstream Process
- Raman model development with Ambr® 250 & BioPAT® Spectro.
- Simultaneous process development and model building to reduce time and cost.
- Effective model transfer to a benchtop-scale bioreactor, improving prediction accuracy and scalability.
👤 Kyung Il Cha, Director; Head, MSAT, GC Biopharma, South Korea
12:30
Lunch Break, Exhibition Viewing & 1-1 Attendee Networking
Exhibition Hall Ballroom B
Downstream Processing: Enhancing Purification and Yield in Biologics
Premier Ballroom A
1:45
Current Trend of Biopharmaceutical Drug Products and Challenges
- Overview of current trends and strategies in biopharmaceutical drug product development.
- Approaches and challenges in designing high-concentration formulations.
- Importance of developability prediction and its role in early-stage development.
👤 Heonchang Lim, Director, Formulation Development, Samsung Biologics, South Korea
2:10
Kleptose®, a Versatile Excipient for Improved Biologic Performance and Stability
- Enhance biologic stability by protecting drug products from physical, mechanical, and processing stresses, reducing the risk of aggregation and degradation.
- Outperform traditional excipients such as polysorbates, offering improved protection of sensitive molecules and better long-term formulation integrity.
- Reduce viscosity in high-concentration biologic formulations, enabling smoother processing, easier administration, and improved patient comfort.
- Improve manufacturing efficiency and biologic recovery, with case studies demonstrating superior performance in formulation robustness and process yield.
👤 Darshana Jain, Technical Development Manager, APAC, Roquette, India
2:35
Basic Introduction of CPV and Different Approaches to Perform CPV (advantage of CPV Autorun)
- Manual vs. Automated CPV – Comparing efficiency, consistency, and risk-based monitoring, with emphasis on the advantages of CPV autorun such as real-time data retrieval, automated analysis, and proactive notifications.
- CPV Automation Architecture – Overview of data flow from sources (LIMS, SAP, manual entry) through processing, integration with enterprise data warehouse, and the impact of master data changes.
- CPV Autorun in Action – Live demo showcasing job scheduling, notification emails, and result interpretation.
👤 MunSu Jang, Associate Director & Site Lead, MSAT, Johnson & Johnson Innovative Medicine, South Korea
3:00
Afternoon Tea Break, Exhibition Viewing & 1-1 Attendee Networking
Exhibition Hall Ballroom B
Analytics and Quality: Ensuring Precision and Compliance
Premier Ballroom A
3:40
Root Cause Analysis for GMP Nonconformities & CAPA Management
- An overview of regulatory requirements and key definitions related to GMP nonconformities and CAPA management
- Practical investigation tools that can be applied for effective root cause analysis
- Approaches to problem solving for CAPAs along with methods to evaluate their effectiveness
- Suggestions and best practices for handling deviations and managing CAPAs effectively
👤 Jonggu Kim, Director, Quality, Lotte Biologics, South Korea
4:05
Case Studies on Recent Trends in US FDA Inspections
- FDA inspection readiness: What key areas of compliance and documentation should we focus on to ensure a successful inspection
- Summary of FDA inspection observations - 2023 and 2024.
- Case Study: Viatris in 2024
👤 Ji-Hyeong Kim, Professor, Yonsei University, South Korea
4:30
Predictive Quality in Biopharmaceutical Manufacturing - From Reactive Compliance to Proactive Excellence
- Reactive Quality (Traditional Model) vs Predictive Quality (Modern Model) to understand the shift from reactive approaches to predictive models.
- Consequences & Benefits by outlining the limitations of reactive quality and the advantages of predictive quality.
- Mindset Change & Cultural Shift required to move from reactive compliance to predictive excellence.
👤 Sia Pheng Tan, Head, Quality Assurance, Prestige Biologics, South Korea
4:55
Chairman Closing Remarks
👤 Devi B. Basnet, Senior Research Scientist, Medytox, South Korea
5:05
End of Conference Day 1
8:50
IMAPAC Opening Remarks
8:55
Chairman’s Opening Remarks
👤 Devi B. Basnet, Senior Research Scientist, Medytox, South Korea
👤 Wei-Han Lee, Director CMC, OBI Pharma, Taiwan
Leadership Panel Discussion: The Evolving Landscape of Antibody-Drug Conjugates (ADCs) in Oncology and Beyond
Premier Ballroom A
9:00
Leadership Panel Discussion: Redefining the Future — Innovation and Real-World Readiness of Next-Generation ADCs
- Discussing the momentum behind next-generation ADCs and the practical challenges of translating innovative designs.
- Examining the potential of ADCs beyond oncology and what it takes to translate innovation into new therapeutic areas.
- How are ADC innovators evolving to accelerate and support the next wave of ADC breakthroughs?
Moderator:
👤 Peng Guo, Principal Investigator, Hangzhou Institute of Medicine, Chinese Academy of Sciences, China
Panelists:
👤 Doo Young Jung, Chief Executive Officer, PinotBio, South Korea
👤 Bryan Yeung, Vice President Chemistry, Axcynsis Therapeutics, Singapore
👤 Tae Kyo Park, Chief Executive Officer, Intocell, South Korea
Automation and Bioprocessing 4.0: The Future of Biomanufacturing
Premier Ballroom A
9:50
Advances in AI-Assisted Pharma Manufacturing with MasterControl Manufacturing Excellence
- A glimpse into the future of Pharma Manufacturing and the ability of 'Assistive Intelligence' to help mitigate risk, prevent deviations and improve efficiency.
- Explore how AI-driven insights, predictive analytics, and real-time process optimization are reshaping pharmaceutical operations.
- Learn how MasterControl Manufacturing Excellence integrates AI to elevate quality outcomes, streamline batch records, and enable proactive decision-making on the shop floor.
- Whether you're modernizing legacy systems or aiming for a true Pharma 4.0 transformation, this session offers practical strategies and real-world examples to help accelerate your digital maturity.
👤 Sue Marchant, Chief Product Officer, MasterControl, United States
Optimizing ADC Target Selection and Engineering for Maximum Efficacy
Premier Ballroom A
10:05
Enhancing the Precision and Efficacy of ADCs: Development of BsADCs
- MOA and Landscape of BsADCs
- Enhancing the Precision and Efficacy by Innovative BsADCs
- Overcoming the CMC Challenges in BsADC Development
👤 Min Zhao, Vice President CMC, Innolake Biopharma, China
10:30
Morning Tea Break, Exhibition Viewing, 1-1 Attendees Networking
Exhibition Hall, Ballroom B
Bioprocessing 4.0, Tech-Transfer & Scale Up Excellence
Automation & Transfer Strategies for Faster Scale-Up
Premier Ballroom A
11:15
Bioprocessing 4.0: Shaping the Future of Smart and Connected Biomanufacturing
- Tracing the evolution of how Korea’s bio-industry has advanced from traditional biologics manufacturing to the cusp of Bioprocessing 4.0.
- Explaining Bioprocessing 4.0 in practice with digital tools, automation, and real-time data to enhance efficiency, quality, and scalability.
- Designing the future by adopting Bioprocessing 4.0 to build agile, sustainable, and globally competitive manufacturing systems.
👤 Hyemi Kim, Head, IT, Lotte Biologics, South Korea
11:40
The Roadmap towards Continuous Manufacturing and Real-time Release of Biologics
- The shift from small molecules to personalized biological medicines and the affordability challenges of monoclonal antibodies.
- The importance of breakthrough technologies to reduce the cost of innovative therapies.
- The potential of decentralized continuous manufacturing to enable low cost and high quality antibody production at point of care and in local markets.
- The future of real time release and same day biologics enabled by inline monitoring and continuous systems.
👤 Koen Dierckx, Founder & CEO, simAbs, Belgium
11:55
Challenges and Best Practices in Technology Transfer of Biologics
- Navigating the complexity of technology transfer across different biologic modalities.
- Addressing key barriers in scale-up and cross-functional coordination during tech transfer.
- Applying proven best practices to minimize risk and ensure seamless process handover.
👤 Jonna Sankaraiah, Lead, Tech-Transfer, Medytox, South Korea
Novel Modalities & Therapeutics: Innovation in the World of Biologics
Premier Ballroom A
12:20
AI-based in silico epitope screening program for the Th-Vac platform to enhance immunotherapy of CD4+ T cell-mediated cancer vaccines
- The Th-Vac® platform is an AI-driven system designed to aid in the development of mRNA cancer vaccines that stimulate CD4+ helper T cells.
- With the Th-Vac® platform, functional epitopes are selected to effectively target tumor-associated antigens, including TROP2, PD-L1, IDO, KRAS, and others.
- The goal of the Th-Vac® platform is to address the current challenges in cancer immunotherapy and to enhance future treatment options.
👤 Wonil Kim, Executive Vice President & Chief Scientific Officer, Aston Science, South Korea
12:45
Lunch Break, Exhibition Viewing, 1-1 Attendees Networking
Advancing Payloads and Linker Technologies for Next-Generation ADCs
Premier Ballroom A
2:00
Discovery and Development of Novel Top1i Payload ADC Platform, Pinot-ADC and Its Applications
- Discovery of Novel Top1i Payload, PBX-7016
- Applications of PBX-7016 in various clinical and preclinical ADC candidates
- Innovative hydrophilic, tandem cleavage linker for improved safety profile of ADCs
- Novel antibody platform to enable DAR 1 conjugates and dual payload conjugates with various DAR.
👤 Doo-Young Jung, Chief Executive Officer, PinotBio, South Korea
2:25
Preclinical Development of AT2604, an ALPP/ALPPL2 Targeting Antibody Drug Conjugate
- Potential first-in-class ADC program targeting alkaline phosphatase ALPP/ALPPL2
- Strong binding to ALPP/ALPP2; selective against other alkaline phosphatase (AP) family members
- In vivo efficacy demonstrated in multiple CDX and PDX tumor models
👤 Bryan Yeung, Vice President Chemistry, Axcynsis Therapeutics, Singapore
2:50
Applications of OHPAS and PMT in ADC Systems
- Structural Overview of OHPAS and Mechanisms of Payload Release
- Mechanistic Insights into PMT
- Development of Novel Camptothecin-Based Payloads
👤 Tae-Kyo Park, Chief Executive Officer, Intocell, South Korea
3:15
TEC Targeting ADC with Highly Potent Bystander Effect
- Tumor endothelial cells and tumor cells targeting
- Bystander effect by using the dual enzymes (caspase-3/7, cathepsin B) sensitive peptide linker
- Potent ADC for the treatment of hyper-vascular tumors
👤 Young-Ro Byun, Founder, Pharosgen Co., Professor, Seoul National University, South Korea
3:40
Chairman Closing Remarks
👤 Devi B. Basnet, Senior Research Scientist, Medytox, South Korea
👤 Wei Han Lee, Director CMC, OBI Pharma, Taiwan
3:50
Afternoon Tea Break, Exhibition Viewing & 1-1 Attendee Networking
4:30
End of Conference
For Speaking Opportunities, Kindly Contact:
Abishek Manoharan
Conference Producer
[email protected] | +65 6983 6137
Share With Your Network
