Join Us at BioJapan 2025

Booth No. D-68 | October 8-10, 2025

Explore the latest innovations in biologics and CDMO solutions

4 Expert-Led Speeches 

CMC Realization of Next-Generation ADCs

As ADCs continue to evolve into more potent and precisely targeted therapies, CMC strategies must also advance to meet these growing demands.
This presentation will explore key considerations in the CMC development of next-generation ADCs, illustrated with real-world case examples.
Designed for biotech and pharmaceutical professionals, the session will offer practical insights into efficient and flexible solutions for ADC development, with a focus on how integrated CMC approaches can enhance quality, scalability, and regulatory readiness from early development through clinical manufacturing.

• Date & Time: October 8, 2025, 15:35–15:50 (15 min)
• Venue: Presentation Stage B
• Speaker: Pei-Chin Tsai, Ph.D.－Pharmaceutical Development Senior Manager at Mycenax

Illuminating the Multi-Mechanism Action of the VLK Linker in ADC Therapeutics

The design of linkers plays a pivotal role in the therapeutic efficacy and safety profile of ADCs. This presentation will introduce the innovative VLK linker and its unique multi-mechanism of action the session will discuss how this technology can potentially overcome current ADC limitations. Case data from preclinical studies will be shared to demonstrate its therapeutic advantages, offering new possibilities in the development of next-generation ADCs.

• Date and Time: October 8, 2025, 15:50– 16:05 (15 min)
• Venue: Presentation Stage B
• Speaker: Yasuhiro Matsumura, MD, Ph.D.－Director of Research at RIN Institute INC.

Decoding Biosimilar Development Through Similarity Assessment

Establishing biosimilarity is the foundation of biosimilar development, requiring a comprehensive and scientifically rigorous comparison with the reference medicinal product (RMP).
This presentation will explore the pivotal role of similarity assessment in guiding CMC strategies throughout the entire development journey—from early-stage development to commercialization—using a risk-based, data-driven approach.
Through case studies and practical insights, the session will illustrate how stepwise analytical justification supports regulatory acceptance.

• Date & Time: October 8, 2025, 16:10–16:25 (15 min)
• Venue: Presentation Stage B
• Speaker: Jheng-Liang Yao－Head of Analytics and Formulation Development Department at Mycenax

Phase-Appropriate CMC Development Strategies for Biologics

Successful biologics development requires CMC strategies that are not only technically robust but also aligned with the distinct requirements of each development phase.
This presentation will provide a practical overview of phase-appropriate CMC planning—from early-stage development through late-phase validation and commercial readiness.
Key considerations such as manufacturability, scalability, comparability, regulatory expectations, and risk mitigation will be explored, illustrating how tailored CMC strategies can reduce development bottlenecks and accelerate both time-to-clinic and time-to-market for biologic products.

• Date & Time: October 8, 2025, 16:25–16:40 (15 min)
• Venue: Presentation Stage B
• Speaker: Pei-Jiun Chen, Ph.D.－CEO & President at Mycenax

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