The Fifth China Biopharmaceutical CMC International Summit | BioCMC Summit

Held timeDecember 2-3,
2021VenueChina•Shangri-La Hotel
, Suzhou OrganizerBest Media｜Best Media, Chinese Pharmaceutical Association Pharmaceutical Engineering Professional Committee
OrganizerBest School of Pharmacy, Yaofangzhou
Cooperative MediaCPhI Pharmaceuticals Online, Yaodu.

Participant registration channel and exhibitor exhibition channel are now officially open.

Sponsor

Speakers

Conference topic

Welcome speech by the organizer of the general assembly

08:30 Challenges and countermeasures in the application process of biological drugs under the new guiding principles
Liu Xun, Deputy General Manager, Hengrui Medicine

09:05 New-generation biopharmaceutical development and production technology innovation
Zhou Weichang, Chief Technology Officer and Executive Vice President, WuXi Biologics

09:40 The latest progress in fully automated and continuous biopharmaceutical production technology
Yang Xiaoming, General Manager, Yi An Jishi

10:15 tea break

10:50 Research and development of BsAb, challenges in CMC and commercial production
Zhou Xinhua, President, Jiahe Biopharmaceutical Co.

11:25 FDA Biological Products Review Key Points and Case Sharing
Wu Youling, Chairman, Zhejiang Teruisi Pharmaceutical Co.

12:00 lunch

Forum 1 Upstream Process Development
Forum Chairman: Tan Wensong, Professor, East China University of Science and Technology

13:30 Large-scale animal cell culture technology
Tan Wensong, Professor, East China University of Science and Technology

14:15 Establishment of quality standards for innovative antibody drugs in the IND phase
Fu Zhongping, Vice President of CMC, Nanjing Weilizhibo Biotechnology Co.

14:45 From early candidate screening to the development and optimization of rapid and producible cell lines
Ye Pei, Deputy General Manager, Beijing Tianguangshi Biotechnology Co.

15:15 diabodies based constructs and cell lines VHH process development
Huangyan Hill, CEO, biological Doyle

15:45 Tea break

16:15 antibody drug production process Cell Line Development Strategy
James Yang, Chief Strategic Development Officer, biomedical Resources Ltd.

17:15 Panel Discussion: Large-scale CHO Engineering Cell Culture Technology
Tan Wensong, Professor, East China University of Science and Technology
Chen Jianxin, CEO, Zhenge Biology

18:00 End of meeting

08:30 Host Selection and Optimization of Highly Expressing Cell Lines
Chunhe Wang, Founder, Da Shi Pharmaceutical

09:15 CHOK1BN cell line authorization and screening strategy
Yang Dong, Director of R&D, Biotech

09:45 CMC strategy and case analysis for the rapid development of innovative biopharmaceuticals
Zhang Yanfeng, Co-founder and President, Alamab Therapeutics

10:15 tea break

10:45 Development of high-expressing cell lines and cell fermentation process
Shen Xiao, President, Hanteng Bio

11:15 Round table discussion: Considerations on the development of stable and high-expressing cell lines and upstream processes in the development of double antibodies
Li Mengjie, Sansheng Guojian, Executive Quality Director

12:00 lunch

13:00 Application of artificial intelligence to QbD Pan
Honghui, CEO, Kangsheng Bio

13:45 Accelerated development strategy of innovative antibody drugs in the IND phase
Li Gang, Senior Director of New Drug R&D Department, Maiwei (Shanghai) Biotechnology Co.

14:15 tea break

14:45 Development of cell lines expressing bispecific molecules
Karen Twu, VP, CMC, and Hutchison Medicine

15:15 Panel discussion: Selection and commercialization of host cell lines
Pan Zhiwei, Senior Director of Process Development and Pilot Production, Suzhou Junmeng Biomedicine

16:00 End of meeting

Forum 2nd Downstream Process Development
Forum Chairman: Kang Yun, General Manager & Senior Vice President of M1 Factory, Cinda Bio
Co-Chair: Lin Dongqiang, Professor, Zhejiang University

13:30 Biopharmaceutical intelligent production
Henrik Ihre, Global Strategic Technical Director, Cytiva

14:15 Application of multi-attribute detection method based on LC-MS/MS in mAb quality research
Ruan Hongqiang, Deputy General Manager, Zhongke New Life

14:45 Antibody Drugs: Thinking from Continuous Manufacturing to Intelligent Manufacturing
Lin Dongqiang, Professor, Zhejiang University

15:15 Application of PAT New Technology in ADC Freeze-Drying Process Development and Production
Liu Xiangyun, Biopharmaceutical Product Specialist, Tegent Scientific

15:45 Tea break

16:15 The latest developments and cases of global intelligent biopharmaceutical factories
Li Shude, Vice President, Happy Land Bio

16:45 Process Development and Challenges of ADC Drugs
Liang Xiao, Chief Operating Officer, Suzhou Yilian Biomedical Co.

17:15
Panel Discussion: Development and Separation Strategy of Robust ADC Drug Purification Process Li Jingrong, CTO, CStone Pharmaceuticals      
Xiao Liang, Chief Operating Officer, Suzhou Yilian Biomedical Co.
, Ltd.

18:00 End of meeting

08:30 Robust deep filtration process scale-up and cost considerations in the monoclonal antibody production process
Wang Bin, Director of China Technology and Service Solutions for Life Science Process Solutions, Merck

09:15 Case study of rapid transfer of innovative antibody drugs from R&D to production
Zhao Yanyan, Director of Antibody Technology Research Department, Shandong Boan Biotechnology Co.
, Ltd.
/Yantai University School of Pharmacy

09:45 Protein purification technology and process control
Zhu Jingjing, Manager of Biology Department, Zhejiang Xinma Biomedical Co.
, Ltd.

10:15 Coffee Break

10:45 Commercial Production of Antibody Drugs: Selection, Cost Estimation and Thinking
Xie Yansheng, Senior Vice President of Production, Terris Pharmaceuticals

11:15 Round table discussion: Main solution production capacity and scale enlargement strategy and consideration points of change
Liu Ding, Deputy General Manager, Qilu Pharmaceutical

12:00 lunch

13:00 latest developments biopharmaceutical purification chromatographic medium
Jiangbi Wang, chairman of Suzhou satisfied Micro Technology Co.
, Ltd.

13:45 Case Sharing: Downstream Process Development for Continuous Conjugation of ADC Drugs

14:15 tea break

14:45 Focus on the process development and design of commercial production
Qi Bo, COO in China, Yiyi Biotechnology

15:15 Roundtable discussion: Production cost control and continuous improvement of production process
Kan Ziyi, Executive Vice President,
Auscon Biotech Wu Qiwei, Vice President of Process Development, Kewang Biotech

16:00 End of meeting

Forum 3 China Biopharmaceutical Preparations and Analysis Summit
Forum Chairman: Shi Li, CEO, Shanghai Zerun Bio
Co-Chair: Liu Cuihua, Senior Vice President, Biotech Bio

13:30 Biological preparation development case sharing
Xiong Changyun, Deputy General Manager, Auscom Biotech

14:00 antibody drug control and analyze product and process related impurities
Shi Liming, scientific analysis, quality control and product development vice president, technology operations, Yian save the world

14:30 Challenges of stability research during the use of intravenous biopharmaceuticals
Li Xinxin, Director of Analytical Preparation, Jiangsu Simcere Pharmaceutical Co.
, Ltd.

15:00 Antibody and vaccine quality and preparation excipient analysis strategy
Cheng Hanxing, Biopharmaceutical Specialist, Shimadzu

15:30 Coffee Break
16:00
Dialects for Quality Research of Bispecific Antibodies , Senior Director of Biotechnology Development Department, Qilu Pharmaceutical

16:30 Multi-parameter stability analysis platform accelerates the development of biopharmaceuticals
Zhang Xi, application expert, NanoTemper

17:00 Tween degradation in biopharmaceutical preparations: mechanism, analysis and particle characterization
Chen Quanmin, Executive Director, WuXi Biologics

17:30 Round table discussion:
Shi Li, Chairman of the Board of Directors, Yidao Biotechnology (Suzhou) Co.
, Ltd.

18:00 End of meeting

08:30 In the process of biopharmaceutical development and production, real-time monitoring of the opportunities and challenges faced by protein aggregation
Zhou Kecheng, President, Biotech

09:15 Advanced Results Characterization of Protein Drugs: Infrared Spectroscopy and Fluorescence Spectroscopy
Zhang Qi, General Manager, Wen Li Biological

09:45 Formulation development of ADC drugs
Lili Xiao, Formulation Director, Meyac Bio

10:15 tea break

10:45 The latest HCP/MAM/charge variant LC/MS application solution-Solving the bottleneck of biopharmaceuticals and improving the research level
Zhang Xiaoxi, Application Engineer, Thermo Fisher

11:15 Challenges and strategies of compatibility stability and transportation verification research
Michelle Zheng, COO, Frontier Biopharmaceuticals (Nanjing) Co.
, Ltd.

12:00 lunch

13:00 Quick method to assess the quality and stability of biological agents - to improve the prediction and screening strategies
LIU Cui-hua, senior vice president, Bio Integration biological

13:45 From protein structure to formulation formulation: How to accelerate formulation development
Han Dongmei, Executive Director of Downstream and Formulation Process Development, Henlius

14:15 tea break

14:45 Protein aggregation and particles caused by production
Tu Sheng, Vice President of CMC, and Qirui Medicine

15:15
Panel discussion: Using innovative formulation technology to develop differentiated biological products Liu Cuihua, Senior Vice President, Biotech Biotech  
Xie Hongwei, Vice President of Product Development, Cinda Bio

16:00 End of meeting

Forum 4 MAH Cooperation and Quality Forum
Forum Chairman: Lin Qiao, Founder/Chairman, Suzhou Jiayu Biology
Co-chair: Yuan Baozhu, Director/Professor, Quality Control Center of Shanghai Zhangjiang National Stem Cell Independent Innovation Industry Demonstration Zone

13:30 CMC due diligence is vital to biotechnology M/A and partners
Zhao Qinghai, Chief Production Officer, Tianyan Pharmaceutical

14:15 How MAH achieves the success of new drugs
Qin Minmin, Senior Deputy General Manager, Shanghai Miac

14:45 MAH's first innovative drug product technology transfer in the
leadership of CMC (case study) Su Jianhua, Chief Technology Officer, Anmai Bio

15:15 The key points of CDMO's third-party management and CMO service for different types of customers
Mou Chenghong, VP, Shanghai Bibo Biomedical Engineering Co.
, Ltd.

15:45 Tea break

16:15 Difficulties in the development of biopharmaceuticals and the choice of MAH
implementation Zou Xiaoming, CEO, Eton King Ang

16:45 How to establish the correct MAH compliance systems and outsourcing cooperation model
Li Jie, the quality of the person in charge, was Kangfang Sheng Pharmaceutical Co.
, Ltd.
Zhongshan

17:15 Roundtable discussion: How to achieve full commercialization of biopharmaceutical products from contract production to the market.
Business model innovation
Xu Jingyi, Head of Asia Pacific Market Quality, Ogalon

18:00 End of meeting

08:30 commercial production - process monitoring and continuous improvement
Lin Qiao, founder / chairman of the board, driving jade biological Suzhou

09:15 How Fast and Better—Accelerating the Development of Gene Therapy Vectors
Huang Lu, Manager of Applied Scientists, Unchained Labs

09:45 How to achieve the first listing of world-class cell products in China
Tao Tongjing, Head of Quality, Fosun Kate Biotechnology Co.
, Ltd.

10:15 Coffee Break

10:45 CAR-T developed a new generation of opportunities and face challenges CMC
LI Wen-peng, senior vice president of strategic planning and product development, bio-Yu Fan

11:15 Use quality requirements appropriate to the stage to accelerate product development
Max Fernandez, Vice President of Quality Regulations and Compliance, Happy Land Life

12:00 lunch

13:00 CMC stem cell product information Basic considerations
Yuan Baozhu, director of the Shanghai Zhangjiang National Quality Control Center for Stem Cell Innovation Industries Demonstration Zone

13:45 Opportunities and Challenges in the New Era of Immune Cells
Wang Liqun, Chairman, Xing Yiang (Shanghai) Biotechnology Co.
, Ltd.

14:15 tea break

14:45 The production quality challenge of non-autologous cell gene therapy
Sun Di, Vice President of Operations/Plant Director, Genxi Bio

15:15 Panel Discussion: Key Points in CDMO Quality Supervision—How to Prevent Supervision from "Out of Control"
Yuan Baozhu, Director, Shanghai Zhangjiang National Stem Cell Independent Innovation Industry Demonstration Zone Quality Control Center
Gary He, Head of Quality, Nanjing Legend Biotechnology Co.
, Ltd.

16:00 End of meeting

Contact: Luke Xia
Tel: 021-60538962
Mobile: 133-0185-8344
Email: luke.
xia@bestmediaworld.
com
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