Join Us at BioJapan 2026

Booth No. C-71 | October 7-9, 2026

Explore the latest innovations in biologics and CDMO solutions

3 Expert-Led Prsentations

Making Advanced ADCs Development-Ready

Next-generation ADCs require more than innovative chemistry. Increasing site precision, payload complexity, and linker flexibility also introduce new challenges in product quality, analytical control, stability, and manufacturability. In this presentation, Mycenax will share its development approach for translating advanced ADC designs into practical CMC strategies. The discussion will include a specific lysine conjugation route for native antibodies and its integration with Mycenax’s multi-arm MMA linker platform. Case-study examples will illustrate how conjugation site, payload architecture, and analytical strategy are evaluated across different ADC formats. We will also discuss linker stability and the transition from early conjugation development to scalable, GMP-ready processes. Together, these examples highlight a development framework that connects molecular design with executable ADC manufacturing.

• Date & Time: October 7, 2026 | 13:50–14:05
• Venue: Presentation Stage B
• Speaker: Pei-Chin Tsai, Ph.D.－Director of Pharmaceutical Development Division at Mycenax

Advancing Downstream Bioprocess Excellence with Gosilico AI Digital Twins

In the evolving landscape of biopharmaceutical manufacturing, downstream process development is shifting from an experience-driven approach to a data-driven strategy to mitigate risks and shorten development timelines.

As an innovative CDMO, Mycenax addresses these bottlenecks by adopting GoSilico AI to establish an In Silico First  workflow. By integrating underlying physical-chemical chromatography principles with mathematical modeling, over 3,000 virtual conditions can be evaluated rapidly prior to wet-lab experiments, achieving a predictive accuracy exceeding 90% in purity and yield.

This presentation shares a real-world CDMO case study on optimizing a Hydrophobic Interaction Chromatography (HIC) process for a bispecific antibody. By replacing the multi-step wash and elution procedure with a streamlined single-step method, Mycenax achieved a 62% increase in loading capacity, a 37% reduction in processing time, and a 39% decrease in buffer consumption. Discover how Mycenax leverages GoSilico AI to transform bioprocesses into decisive manufacturing advantages and elevate existing bioprocesses to premium standards.

• Date and Time: October 7, 2026 | 14:05– 14:20
• Venue: Presentation Stage B
• Speaker: Pei-Jiun Chen, Ph.D.－CEO & President at Mycenax

Executive Strategies for Global GMP Compliance:
Ensuring Quality and Inspection Readiness in Drug Product Manufacturing

Mycenax showcases advanced Drug Product (DP) manufacturing at its Taiwan facilities, supporting complex molecules (including mAbs, BsAbs, fusion/recombinant proteins) through robust liquid and lyophilized formulation processes.

The operational framework implements a holistic Quality by Design (QbD) methodology, mapping out critical processing parameters and validation targets across the aseptic filling workflow.

Strategic Compliance & Inspection Readiness

•    Aseptic Process Simulation (APS): Integrates routine and non-routine interventions, operator rotations, and worst-case timelines, leveraging a bracketing approach to optimize validation efficiency while widening audit coverage.

•    Visual Inspection Personnel Qualification: Mandates documented qualification and periodic re-evaluation procedures for all inspection personnel, paired with regular vision checks and the structured management of physical non-defective/defective standard limits.

•    Contamination Control Strategy (CCS): Implemented as a mandatory, facility-wide master plan, the CCS bridges process mapping, formal risk assessments, layered technical/procedural defenses, and continuous lifecycle reviews to systematically eliminate contamination vectors and guarantee long-term product safety.

• Date & Time: October 8, 2026 | 13:50–14:20
• Venue: Presentation Stage B
• Speaker: Toby (Pang-Liang) Liu－Vice President of Operation Center at Mycenax

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