プレナリー基調講演

ADAPTING TO GLOBAL BIOPROCESSING DEMANDS AND EVOLVING PIPELINES
世界的なバイオプロセシング需要への適応と進化するパイプライン

CMC Strategies for Diverse Pipelines and Complex Modalities
Christian Hunzinger, PhD, Senior Director and Head, CMC Development Proteins, ADCs and Chemical Entities, BioNTech
Biopharmaceutical treatment paradigms are shifting from monotherapy towards multi-target approaches with complex multimodal entities. This complexity also translates into increasingly complex CMC development and manufacturing strategies. The talk will provide a general overview on recent developments, challenges, and opportunities, along with examples from various stages of the CMC development lifecycle.

Enhancing Process Development: Balancing Yields with Downstream Efficiency and Emerging Technologies
Oliver Kaltenbrunner, PhD, Scientific Director, Process Development, Amgen Inc.
Explore the evolving landscape of process development, emphasising the critical balance between maximising yields and optimising downstream processing. This presentation will delve into the impact of upstream processes on primary recovery, integrating cutting-edge technologies like Process Analytical Technology (PAT), advanced modelling, and artificial intelligence. Supported by real-world examples, we'll examine how these innovations are reshaping process efficiency and performance in the industry.

---

Biographies

Christian Hunzinger, PhD, Senior Director and Head, CMC Development Proteins, ADCs and Chemical Entities, BioNTech
Christian is Senior Director, CMC Development Proteins, ADCs & Chemical Entities at BioNTech SE. Christian holds a PhD in Biology from the University of Mainz, Germany. He has 25 years of experience in biotech and pharmaceutical industry with a broad technical expertise ranging from early target and biomarker discovery up to late-stage CMC development and commercial manufacturing of protein-based biologics. Prior to joining BioNTech, Christian worked in various positions at Rentschler Biopharma SE, Merck KGaA and ProteoSys AG.

Oliver Kaltenbrunner, PhD, Scientific Director, Process Development, Amgen Inc.
Oliver Kaltenbrunner is a Scientific Director of Amgen Process Development and has extensive experience leading the advancement of clinical and commercial processes through their development cycle. Roles have focused on commercial and clinical process support, process optimization, process economics, multi-site engineering strategies, process transfer, and validation support. Currently, he leads a Manufacturing Technologies group, overseeing the introduction of new technologies into GMP manufacturing of therapeutic biologics.

---

Track Keynotes and Featured Speakers

Krist V. Gernaey, PhD, Professor, Chemical & Biochemical Engineering, Technical University of Denmark

Jorgen B. Magnus, PhD, Professor & Chair, Biochemical Engineering, RWTH Aachen University

Gisela M. Ferreira, PhD, Senior Director, AstraZeneca

Marcel Ottens, PhD, Professor, Biotechnology, Delft University of Technology

Advait V. Badkar, PhD, Executive Director & Head, Nanoparticle Development, Pfizer Inc.

Ana Sofia Coroadinha, PhD, Lab Head, Health & Pharma Division, Animal Cell Technology Unit Cell Line Development and Molecular Biotechnology Lab, IBET

Paula Alves, PhD, CEO, iBET

Vered Caplan, CEO, Octomera and Orgenesis

Lara Fernandez-Cerezo, PhD, Associate Principal Scientist, Merck

Richard D. Braatz, PhD, Edwin R. Gilliland Professor, Massachusetts Institute of Technology

Elena Dominguez Vega, PhD, Assistant Professor, Center for Proteomics and Metabolomics, Leiden University Medical Center

Dan Bach Kristensen, PhD, Scientific Director, Symphogen

Peter Neubauer, PhD, Lab Head, Bioprocess Engineering, TU Berlin

Bettina Knapp, PhD, Lab Head, Upstream Development, Boehringer Ingelheim