BioAQ 2026 Shanghai Summit: Tackling Industry Challenges with 50+ Pharma Leaders and 10 Thematic Sessions

Mar 03, 2026 15:22 CST Updated 15:22

Hengrui Pharma

Innovative and High-Quality Pharmaceutical Developer

"Everything Revives in Spring, Embarking on a New Journey Together"

BioAQ2026 Shanghai: Limited-Time Offer for Observation Passes

Ten Major Special Sessions,50+Keynote Speaker,90%From the Frontlines of Pharmaceutical Companies

Roche, BMS, National New Drug Review Experts, Hengrui Pharma, BeiGene, Innovent Biologics, WuXi Biologics, RemeGen, Chia Tai Tianqing, Qilu Pharmaceutical, 3SBio, GenScript, Asymchem……30+Leading pharmaceutical companies,60+Renowned Industry Guests, Gathered TogetherBioAQ 2026！

No empty talk; we directly address industry hotspots and challenges, focusing on in-depth technical exchange.4Month2-3Shanghai Fengxian Hilton, waiting for you!

Others:To facilitate attendance for all colleagues, we have established a fixed round-trip shuttle service between “Zhangjiang High-Tech Park Metro Station” and the “Hilton Shanghai Fengxian Qiansheng Hotel,” offering complimentary transportation to and from the conference. The specific routes and schedules will be sent to registered attendees one week prior to the event.

How to ObtainBioAQ2026 ShanghaiObservation Ticket

【Event Duration】From now untilMarch 15Previously effective

[Acquisition Steps]Scan the QR code below to complete the registration form and receive a complimentary observer pass for the BioAQ 2026 Shanghai Summit (meals not included). Upon approval, we will contact you to confirm your registration.

[Event Quota]Limited-Time Access 66ZhangObservation Tickets: Available While Supplies Last

[Scope of Invitation]R&D and Management Personnel from Pharmaceutical Companies and Research Institutions

Admission Ticket: Limited-Time Free (0 CNY) (Original price: 500 yuan/person)

Two-day conference fee + simplified conference materials + two-day tea break fee

Shanghai Baishi Culture Media Co., Ltd. reserves the final right of interpretation for this event. For any inquiries, please contact Baishi Media customer service via WeChat. Thank you once again for your continued support and appreciation!

【Customer Service QR Code】

Baishi Media | Best Media

March 2, 2026

Conference Introduction

The Bioanalytical and Quality Summit (BioAQ Summit), as a premier platform for exchange in the field of biopharmaceutical analysis and quality, brings together top industry experts and corporate leaders to focus on cutting-edge technologies and innovations in quality control within the realms of protein therapeutics, peptide-drug conjugates, and cell therapy. The conference covers antibodies, fusion proteins, recombinant proteins, andADC Drugsdruggability assessment, early-stage analytical technologies, process development and scale-up, and the establishment of commercial quality control systems. The special topic on peptides and XDC conjugates provides an in-depth discussion on structural elucidation, isomer and impurity profile analysis, purification challenges, process scale-up, and international regulatory compliance strategies. The cell therapy sector focuses primarily onCAR-T and CAR-NKDrugability assessment, critical quality attribute (CQA) studies, process characterization and optimization, and GMP compliance requirements, integrated with CRISPR gene-editing technology, viral vector delivery, and digital intelligent quality control systems, throughout lifecycle management and regulatory interpretation.

The conference provides an in-depth analysis of global registration regulations and multi-center submission strategies, promoting the implementation of risk-based Quality by Design (QbD) and Quality Risk Management (QRM) systems to help enterprises achieve efficient compliance and international expansion. Through multi-dimensional technical sharing and practical experience exchange, it drives industrial technological upgrades and the refinement of quality systems, empowering the biopharmaceutical industry to meet future challenges and realize sustained innovation and high-quality development.

Event Duration:April 2–3, 2026

Venue:Hilton Shanghai Fengxian QianshengHotel (No. 818, Rongqin Road, Fengxian District, Shanghai）

Conference Scale:500 people

Organizer:China Association for Quality and Safety Promotion of Food and Drug Enterprises

Organizer:Baishi Media, Wuhan Hanhai New Enzyme BiotechnologyCo., Ltd.Shanghai Hanuowei Biotechnology Co., Ltd.

Supported by:Shanghai Industrial Comprehensive Development Zone

Expert Advisory Committee:

Conference Highlights

Conference Structure

Attendee Profile

Guest Speakers

(Listed in no particular order; continuously updated...)

Schedule

Main Forum: Analytical Quality and Regulations

Interpretation of Biologic Drug Registration Regulations, Quality Analysis and Submission Strategies, Risk Management and Change Compliance, Risk-Based Quality Systems, and Global Regulatory Trends

♦ From IND to BLA: Tackling Analytical Science and Quality Strategy Challenges for Dual US-China Filings of Complex Biologics (Using ADCs as an Example)

Chen Ying, VP, WuXi XDC

♦ End-to-End Practice and Key Quality Control Points for Biologics from IND to NDA Submission

Wang Junzhi, Academician, Chinese Academy of Engineering (TBC)

♦ Research on Quality Standards for Biotechnological Drugs

Rao Chunming, Former Director of the Recombinant Drug Division, National Institutes for Food and Drug Control

♦ Roundtable Discussion: Focusing on the New Edition of the Chinese Pharmacopoeia and New Regulatory Policies—Analytical Quality, Regulatory Challenges, and Countermeasures for Biologics

Moderator: Tang Minhao, Former Deputy Director/Chief Researcher of the Shanghai Municipal Food and Drug Administration; Shanghai Society for Food and Drug Safety

Bian Feng, Executive Director, Head of Integrated Science Team, Global Drug R&D China, Bristol-Myers Squibb (BMS)

Liu Cuihua, Former Senior Vice President,Bio-Thera

Sub-forum 1: Quality Control and Analysis of Protein Therapeutics

Session 1: Antibody Drug Quality Control and Analysis

Focusing on the design, structural elucidation, process development, and quality control of antibody therapeutics, including monoclonal antibodies, bispecific antibodies, and multispecific antibodies.

Structural Analysis, Process Development, Quality Control

♦ Druggability Assessment of Antibody Drugs: An Integrated Strategy from Candidate Molecule Screening to Preclinical Evaluation

Liu Li, Ph.D. Supervisor / Co-founder, formerly of Zhijiankang

♦ Quality Control Strategy for Bispecific Antibody Drugs: An Integrated Perspective from CQA Identification to Lifecycle Management

Cecie Jiang，VP of Quality，Biotheus

♦ Applications of Mass Spectrometry in the Development of Biopharmaceuticals

Yiling Lu, Technical Director, Biocytogen

♦ Challenges in Antibody Quality Control: CQA Identification and Quality Control Strategies from a CMC Perspective

Rong Peng, Large Molecule CMC Analysis Expert, Roche China Innovation Center, Roche Group

♦ Statistical-Based Quality Control Strategies for Biopharmaceuticals

Wang Yingwu, Chief Scientist of Analytical Development, Changchun GeneScience Pharmaceuticals

♦ Key Considerations and Case Studies in the Large-Scale Production of Antibody Drugs

Huang Qing, Deputy General Manager, Nanjing Shunxin Pharmaceutical Co., Ltd. of Chia Tai Tianqing Pharmaceutical Group

♦ Roundtable Discussion: Key Challenges in Quality Control and Industrialization Breakthroughs of Antibody Drugs—Technical Complexity, Target Innovation, and Intelligent Empowerment

Zhang Zhongli, Vice President of Quality Research and R&D QC, RemeGen

Sun Yongbao, Deputy General Manager, Qilu Pharmaceutical Biotechnology Company

Li Mengjie, Senior Director of Quality, 3SBio Inc.

Wang An, Head of Quality, Longrun Mediview

Session 2:Recombinant Protein and Fusion Protein Analysis Session

Protein Drug Sequence Optimization, Functional Evaluation, Process Characterization, and Quality Control

♦ Analytical Methods for the Drug Metabolism of FGF21 Analogs

Zhou Zhenxing, Senior Director of Bioanalysis, Dorr Biology

♦ Host Cell Protein Impurity Testing and Quality Control Strategies

Bi Xuezhi, Senior Chief Scientist, Bioprocessing Technology Institute, Agency for Science, Technology and Research (A*STAR), Singapore

♦ Core Reagents for Ultra-High-Resolution Mass Spectrometry-Based Protein Characterization and Technical Solutions for Glycopeptide Characterization

Feng Yu, General Manager, Shengxia Protein

♦ Addressing the Challenge of High Heterogeneity: Structural Characterization and Quality Control Strategies for Complex Recombinant Protein Therapeutics

Wang Guanbo, Research Fellow, Peking University

♦ Roundtable Discussion: “Developability” Challenges and Innovative Strategies for Recombinant Protein Drugs

Session 3:Quality Control and Process Innovation for ADC Drugs

Analysis of Complex ADC Structures, Process Optimization, and Quality Studies

♦ A Brief Analysis of Stability Challenges in ADC Drugs and the Upgrade of Quality Control Strategies

Sun Xiaolan, Senior Director, Hengrui Pharma

♦ Quality Research and Quality Control Strategies for ADCs

Cao Xingjun, Senior Director, Innovent Biologics Group/Sherpa Bio

♦ Challenges and Strategies in the Quality Characterization of ADC Drugs: From Drug-Loading Distribution to Heterogeneity Control

Hu Wentao, Director of the Research Department, Quality Division, RemeGen

♦ Impurity Analysis Strategy for ADC Drugs

Yao Xuejing, Head of Early Research and General Manager of the Quality Department, Central Research Institute of Shanghai Pharmaceuticals Group

♦ Quality Risk Management in ADC Process Characterization and Process Validation

Pan Zhiwei, Vice President of CMC, TopAlliance Biosciences

Subforum 2: Quality Control and Analysis of Cell Therapy Products

Session 1:Analysis and Quality Control of Cell Therapy Products

Lifecycle Management and Regulatory Validation Requirements for Analytical Method Development of CAR-T and CAR-NK Therapies

♦ Quality Control and Regulatory Focus for CRISPR-Based Cell Therapy Products

Zhang Changfeng, Director of Biologics Quality and Registration, Shanghai Pharmaceuticals Group

♦ Topics Related to CAR-T Cell Products (TBC)

Zhang Tongcun, Chairman, Boruida Bio

♦ Off-Target Detection for CRISPR-Edited CAR-T Cells and Analysis of FDA Black Box Warnings

Xu Zhongwei, Chairman/Chief Scientist, Basecell

♦ Key Quality Control Challenges and Response Practices in the Clinical Translation of CAR-T Cell Therapy

Guo Wenzhong, Vice President and CTO of the Industrial Platform, Peking University Ningbo Institute of Marine Drug Research

♦ From Clinical Breakthroughs to Reliable Delivery: Applications of Universal Off-the-Shelf NK Cells in Oncology Clinical Treatment and Prognostic Management

Miao Zhenwei, Chairman & CEO, Imunopharm &iCare

♦ "Clinical Value-Oriented: Core Logic and Practice in Establishing Quality Standards for Cell Therapy Products" (TBC)

Xia Jianchuan, Postdoctoral Fellow at Harvard University; New Drug Review Expert for the National Medical Products Administration

♦ Roundtable Discussion: “Breaking Through to the Future: New Strategies for Cost-Effective Quality Control and Commercial Win-Wins in Cell Therapy Products”

Session II:Cell Therapy Process Development and Quality Control

Quality System Development: Control of Critical Process Parameters, Detection of Viral Vector Impurities, and Process Analytical Technology

♦ 818" Quality Management Logic for Cell Therapy Products under the Regulations

Yuan Baozhu, Founder / Professor, Zhiding Biotech / Tongji University

♦ Innovative Technologies for Quality Control and Testing of Cell Therapy Products

Wang Anxin, Head of R&D Center, Huode Biologics

♦ Development and Validation of Quality Control Methods for iPSC-Derived Cell Therapy Products

Zhang Ying, Co-founder & CTO, Zhongsheng Suyuan

♦ Quality Considerations for Lentiviral Drug Products in In Vivo Cell Therapy

Xinpo Jiang, Assistant Vice President, Product Business Unit, GenScript Biotech

♦ Roundtable Discussion: Dual Drivers of Innovation and Compliance: How to Build Core Competitiveness for Next-Generation Cell Therapy?

Session 3:Quality Control and Regulatory Filing for the Commercialization of Cell Therapy

Focusing on Registration Strategies, Regulatory Policy Interpretation, Quality System Development, and Responses to Regulatory Inspections

♦ "The Commercialization Path of Innovative CAR-T Products: From Differentiated Design, CMC Challenges to China-US Submission Strategies"

Yu Lei, Chairman, Youkadi (TBC)

♦ Latest Advances in Quality Standards and Quality Control Strategies for Cell Therapy Products

Gao Yang, Founder & CEO, Beijing Fange Technology

♦ Key Challenges and Response Strategies in the Development of Critical Quality Control Methods for Cell Therapy Products

Li Rui, Senior Director of Quality, Xingyiang

♦In Vivo Lentiviral CAR-T Therapy: The Path to Industrialization from R&D to CMC

Wang Min, Vice President, Genesis Pharma

♦ From Regulatory Submission to Manufacturing: Building the Core Pillars of a Commercial-Grade Quality System for Cell Therapies

Zhang Zhengkun, Global Quality SystemDepartment Head, Hengrui PharmaMedicine

Sub-forum 3: Innovation in Quality Control of Peptides and XDC Drugs

Session 1:Analysis and Quality Control of Peptide Drugs

Structural Analysis, Impurity Identification, Quality Standards, and Regulations for Peptide Drugs

♦ Development and Quality Control Analysis of Peptide-Based Weight Loss Drugs

Dr. Deng, Member of the National Pharmacopoeia Commission; National Expert for Registration and On-site Inspection of Biological Products

♦ Strategic Value of Bioactivity Assays in CMC Submissions for Peptides and Peptide Derivatives

Lu Xinyuan, Senior Director, WuXi Biologics

♦ Challenges in Quality Analysis of Peptide Drugs and Innovative Response Strategies

Speaker, Elsevier

♦ Strategies for In Vitro and In Vivo Metabolic Analysis of the Novel Drug PDC LN005

Diao Xingxing, Researcher, Shanghai Institute of Materia Medica, Chinese Academy of Sciences

♦ Development of Detection Methods and Risk Control for Host Cell Proteins (HCP) in Peptide Drug Production

Xing Wancai, Director of R&D Analytics, Gan & Lee Pharmaceuticals

♦ CMC Research Strategy and Quality Control for Peptide Drugs Throughout Their Lifecycle

Ma Yaping, Chairman, Shenchuang Biotech

♦ Roundtable Discussion: The Next Frontier for Peptide Drugs: Beyond GLP-1, Overcoming Technical Bottlenecks and Industrialization Challenges

Session 2:XDC Conjugate Drug Manufacturing and Quality Control

XDC Conjugation Efficiency Analysis, Carrier Design, Purification Process, and Quality Control

♦ Analysis and Impact of XDC Drug Release Kinetics

Ji Ao, Co-founder & CSO, Bairuiyi Bio

♦ Full Lifecycle CMC Management of ADC Drugs: Key Considerations from Early Process Development to BLA Submission

Hongbin Song, Senior Director of ADC CMC, Innovent Biologics Group / Sherpa Bio

♦ Impact of Payload-Linker on the Quality Attributes of Antibody-Drug Conjugates and Analytical Control Strategies

Chen Weibin, Deputy General Manager, Asymchem

♦ Statistical Strategies for Comparability of Analytical Methods and Process Changes in Biologics

Shengnan Cai, Director of Statistics, Head of CMC Statistics, BeiGene

♦ Roundtable Discussion: The Future Landscape of XDC: A Multidimensional Interplay of Technological Innovation, Production Challenges, and Quality Control

Session 3:Key Challenges and Countermeasures for Peptides and XDC Drugs

Impurity Analysis, Mass Spectrometry Technology, Process Testing, Data Quality Control, CMC Filing

♦ From CMC Strategic Planning to the Successful Path of Global Commercialization

Liu Cuihua, Former Senior Vice President of Bio-Thera Solutions, Current Pharmaceutical Internationalization Consultant

♦ Development and Optimization of a Combined Solid-Phase and Solution-Phase Process for Cyclic Peptides

Zhang Yurui, Director of Peptide R&D, Nuotai Bio

♦ Impurity Control Strategy for Peptide Active Pharmaceutical Ingredients

Liu Biao, General Manager, Sichuan Duorui Pharmaceutical

♦ Stability Challenges in Peptide Therapeutic Development: From High-Concentration Aggregation to Transportation Stability

Mingyang Hei, Director of Formulation Process, Innovent Biologics Group

♦ Quality Analysis and Regulatory Challenges in Peptide BLA Submissions

Zheng Luxia, Deputy Director of the Institute of Biochemical Pharmaceuticals, Shanghai Institute for Food and Drug Control (TBC)

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