General Assembly

• Detailed Explanation and Case Analysis of the QbD Whole Process Lifecycle

• Global IND Application Differences and Different Perspectives on Review and Evaluation

• Integration of QTPP and Risk Assessment and Control Strategies for R&D Process

• Panel: How to Align with ICH-Q10 for Building Internal Quality System and Quality Culture in a Company?

Forum I: Special Session for Antibody Drugs

• Study on Quality Control of PD-1/CTLA-4 Dual Antibodies

• Development and Quality Control of Dual-Antibody and Dual-Antibody ADC Drugs

• Quality Methods Research/Data Interpretation of Pharmacodynamics and Pharmacokinetics

• Quality Analysis and Structural Characterization Techniques of Antibody Drugs

• QbD-based Pharmaceutical Validation

• Case Study and Sharing on Technology Transfer for Mass Production of Antibody Drugs

• Quality Control Strategies and Regulatory Requirements for Raw and Auxiliary Material Packaging

• Heterogeneity Analysis Method Development and New Technology of Complex Antibody Based on QbD

• Particle Study Ensures the Safety of Biological Agent

• Cultivation Process Optimization and Regulation Strategies for Antibody Heterogeneity Control and Case Study

• New Approaches and Methods for HCP Detection under Regulatory Challenges

• Evaluation and Control of ADC Critical Quality Attributes (CQA) in the Manufacturing Process

• Data Integrity Management and Practice

• Key Points of Quality Control in Site Inspection of Monoclonal Antibody Registration Production

• Challenges and Control Strategies for CMC Quality of Late-Stage Clinical Innovative Biopharmaceuticals

Forum II: Special Session for Cell Therapy Drugs

• Quality Control and Regulation of Cell and Gene Therapy Products

• Guardian of Cellular Quality

• IInterpretation and Implementation Cases of "Guideline for Quality Management of Cell Therapy Product Manufacturing"

• Sterile Analysis Ensures CGT Product Safety

• Regulatory Requirements for GMP Quality Essentials of Viral Vectors

• Batch-to-Batch Evaluation Strategies for Compliance: It Varies on the Perspectives to Assess Batch Process Stability 

• Key Regulatory Points on Quality Testing and Release of Stem Cell Preparations

• Quality Control of Gene Modification Carriers / GMP Quality of Plasmids

• How to Develop Quality Analysis Methods and Standards to Help Ensure the Safety and Efficacy of TCR-T Products?

• Discussion on Quality Research and Quality Control of Cell Therapy Products

• Key Quality Control in the Development Process of Universal NK Cell Drugs

• Quality and Efficacy Control of Solid Tumor Cell Therapy

• Quality Control of Clinical-grade Cell Production: How to Establish a Standardized Flow Cytometry Analysis Strategies

• Analysis of the Difficulties in Establishing the Standardized Preparation and Quality Control System of TIL Cells

• Challenges in the Development of New Generation Universal Variant Products and Analytical Methods

• Experience Sharing on UCAR-T Cell Product Quality Control and IND Application

• Quality Management of Cell Products Based on Life Cycle

• How to Establish a Quality Control System for Expanded γδ-T Cells and Preclinical Safety Evaluation for Clinical Treatment
  

Forum III: Special Session for Nucleotide Drugs

• Progress and Quality Control Strategies of ASO Solid Phase Synthesis Technology

• CMC Production of Nucleic Acid Drugs under QbD Strategies

• Strategies for Circular RNA Circularization Impurity Removal and Key Quality Attributes

• Quality Control of siRNA and IND Application Strategies in China and the United States

• Development and Progress of Nucleic Acid Drug Bioanalysis Methods 

• Delivery Modes and Safety Considerations of Small Nucleic Acid Drugs

• Strategies for Quality Management in Ophthalmic Gene Drug Clinical Trials

• Regulatory Requirements and Application Considerations for Plasmid Materials of GeneTherapy Drugs

• Clinical Quality Control Strategies for β-Thalassemia Therapy

• Gene Therapy Drugs - Establishment of Quality Control and Quality Standards

• Interpretation of Overseas Regulatory Requirements and Key Focuses on Gene Therapy Drugs

• Considerations on Yield and Quality in Large-Scale mRNA Purification Process

• Innovate High-Throughput Platforms and Break Nucleic Acid Drug Analysis Bottlenecks in A Multidimensional Way

• Structural Characterization of mRNA Drugs and Verification in Process Changes

• Key Points in Quality Control and Regulatory Interpretation of Slow Virus LV and other Viral Vectors

• Clinical Progress and Quality Control of Oncolytic Virus

• Strategies for AAV Drug Quality Control and IND Application / Capsid

Forum IV: Special Session for Global Pharmaceutical Policy and Regulatory Landscape

• How Pharmaceutical Companies Should Cope with and Address High-frequency Rectification Issues under the Storm of Unannounced Inspections

• ICH Q5A Evaluation of the Viral Safety of Biotechnological Products Derived from Human or Animal Cell Lines

• Stage-adapted Product Reference Control and Iterative Strategy

• Precision Identification and Evaluation of Biopharmaceutical Microbial Strains Based on Whole Genome Sequencing Technology

• Interpretation of "Guideline on Quality Risk Management for Co-Line Production of Drugs"

• Application of New Technologies and Concepts such as MAM and PAT in Quality Control 

• Stage-adapted Product Reference Control and Iterative Strategy

• Precision Identification and Evaluation of Biopharmaceutical Microbial Strains Based on Whole Genome Sequencing Technology

• Interpretation of "Guideline on Quality Risk Management for Co-Line Production of Drugs"

• Application of New Technologies and Concepts such as MAM and PAT in Quality Control 

• Non-Clinical Research and Assessment on CGT Products from a Review Perspective

• Conceptual Interpretation of GMP Production Management of Biomedicine Batching from Declaration to Commercialization

• FDA Regulatory Requirements for BLA Marketing

• What Steps Need to be Taken to Obtain Multi-country Marketing Authorization Qualifications for Pharmaceuticals in the European Union?

• How Chinese Pharmaceutical Companies Harness the BRI Wave to Promote Market Expansion and Cooperation

• Accelerate the Development of the ASEAN Market, and Boost the Global Market Expansion of Chinese Biopharmaceutical Companies

• Strategies for Overseas Contract Manufacturing Site Change, Process Management and Control
  

Past Guests（incomplete）

The 4th Quality Science of Biologics Summit in 2023 will provide you with cost-effective and bespoke sponsorship programs. Don't miss our conference if you expect a new product promotion plan in 2023 or get up close with pharmaceutical company decision makers!

For customized exhibition/academic exchange/registration/media cooperation, please contact:

Contact: Abby

Cell phone: 18217659261 (as well as WeChat ID)

Email: xiaolang.jiang@biovalleyclub.com

Sponsorship quota is limited! 

BioValley is a biopharma and biotechnology focused knowledge community. BioValley is the leading member of “Innovation China” Biopharma Industry Science & Technology Service Group, led by Chinese Society for Microbiology (CSM) under China Association for Science and Technology (CAST). In the spirit of Focus & Originality, BioValley is committed to providing the high-value knowledge, holistic consulting services, and precision marketing solutions to the entire biopharmaceutical industry.

BioValley has six new media brands - Biovalley, Biotitude, Immunology Chat, BioV-Test, Bio Frontier, Bio Career Express Bus, with totally 300,000+ subscribers. Over 70% of them are industrial leaders at or above manager levels, including CEOs and entrepreneurs. For these talents, we empower them with the cutting-edge knowledge, specialized training, and career opportunities. For their enterprises, we provide precision marketing and branding solutions, industrial connections, R&D consulting, employee training and recruitment, etc. BioValley has been recognized as a platform with “attitude, altitude, warmth”, a close liaison for all stakeholders on the value chain of this industry.

Up to now, BioValley has released 2300+ original articles attracting totally 85 million readings and organized 100+ webinars reaching 32,000 audiences. Every year, BioValley organizes several high-level national conferences and industrial exhibitions such as Bio-ONE, QbD, and CGCT. In the future, we are dedicated to continuously empowering the biopharma industry, with the ambition of becoming the leading biopharma knowledge community in China.  

Beijing Corregene Biotechnology Co., Ltd. (Life Science Park, Changping District, Beijing) was co-founded in 2016 as a platform for TCR innovative drug research and development in China by a number of Peking University alumni and overseas returnees. Corregene has won numerous awards since its inception, including National High-Tech Enterprise, Zhongguancun High-Paying Technology Enterprise, the winning prize of the Maker Beijing 2021 Innovation and Entrepreneurship Competition "Xiuzheng Health Innovation Special Competition," and entry into the Zhongguancun International Frontier Science and Technology Innovation Competition "Zhongguancun Frontier Technology Biology Medicine, TOP10", the "Star List 2021 Top 50 Most Innovating Companies."

Corregene now has 325 intellectual property rights, including 9 invention patents, 6 utility models, 5 computer software copyrights, 303 registered trademarks, and 2 art work copyrights. Corregene has developed the world's leading TCR affinity optimization technology SMART-TCR, which greatly improves the success rate and efficiency of TCR affinity optimization and breaks down barriers to developing innovative TCR drugs, as well as the affinity optimization technology based on revolutionary T-cell antigen recognition receptor (TCR). The company has established an international leading whole-process platform for the development of TCR innovative drugs, with a highly automated and fully closed production process to deliver products complying with Chinese, American and European standards.

Under the direction of a professional R&D team and management team, Corregene has been involved in the development of novel T-cell antigen recognition receptor (TCR) drugs with an eye on the broad potential of such medications. Its main deliverables are first-in-class TCR-T cellular therapy products and soluble TCR protein drugs, including the first cellular therapy drug targeting the KRAS-G12 mutation in China and the world's first TCR protein drug for the treatment of HPV infectious diseases, which are used to treat multiple tumors and chronic infections. Two products are currently in IIT clinical trials.

Corregene has the top technical team and skilled experimenters in the industry, as well as a rich product pipeline with promising market prospects. The company prioritizes in-house innovation and remains committed to becoming the world's TCR immunotherapy field leader!

GenScript ProBio, a subsidiary of GenScript Biotech Corporation, offers end-to-end CDMO services from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in CGT, vaccine, biologics discovery and antibody protein drug, aiming to accelerate drug development for customers. GenScript ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 40 IND approvals since October 2017.

GenScript ProBio’s total CGT solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. GenScript ProBio’s innovative solutions for biologics discovery and development include therapeutic antibody discovery, antibody engineering and antibody characterization. In the biologics CDMO service, GenScript ProBio has built a DNA to GMP material platform, including stable cell line development, host cell commercial license, process development, analytical development to clinical and commercial manufacturing, and offer fed-batch and perfusion processes to meet the growing needs for antibody and protein drugs. GenScript ProBio has established GMP capacity that meets regulatory requirements of the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and National Medical Products Administration (NMPA).

Toward the mission of “Innovation through Collaboration”, GenScript ProBio is committed to helping customers shorten the timeline for the development of biological drugs from discovery to commercialization, significantly lowering R&D costs and shaping a healthier future.

The "Innovation China" Biomedical Industry Technology Service Group, led by the Chinese Society for Microbiology, works with colleges and universities, research institutes, industry-leading enterprises and application bases to address the development and innovation needs of the microbial industry. Their aim is to sustainably develop biomedical innovation research and talents, thereby accelerating the integrated development of the Beijing-Tianjin-Hebei region, the Yangtze River Economic Belt, the Yangtze River Delta, the rise of central China, and the trailblazing development of eastern China. They will remain deeply involved in the fields of biomedicine, microbial medicine, microbial fermentation technology, and microbial amplification technology, offering specialized services integrating biomedical technology, equipment, consultation, information, training, and education to pharmaceutical enterprises, agricultural pharmaceutical enterprises, and food fermentation enterprises. They will collaborate with schools and businesses to accelerate the integration of theory and practice in microbial strain transformation technology, fermentation optimization technology, scale-up technology, and engineering design, delivering an infinite array of practical talents to the industry.

Main services include: research and development of microbial medicine; production of fermentation products; fermentation engineering design; consulting services for cellular drug, antibody, or vaccine drug preparation technology; industry reporting; workplace education and training services; intellectual property services; project transaction services; solutions for biomedical precision marketing; biomedical investment and financing services.

Chinese Biopharmaceutical Association-USA (CBA) is one of the largest Sino-American professional technical associations in the United States. CBA was created in 1995 as a 501(c)(3) certified tax-exempt organization. The primary mission of CBA is to promote comprehensive exchanges between US and Chinese biopharmaceutical professionals, as well as to create an environment in which biopharmaceutical companies and research institutions can grow and succeed. Based in Maryland, CBA San Francisco branch extends across the east and west coasts of the United States, currently serving more than 8,000 members, including more than 60 institutional members. Most CBA members are from biopharmaceutical companies, universities, research institutes and government agencies. More than 80% of CBA members have doctoral degrees. The CBA has members from China, Europe, Canada, Australia, Singapore, and Japan in addition to those from the United States. CBA has been actively encouraging collaboration between the Chinese and American biopharmaceutical industries ever since it was founded.