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The 4th Annual Bioprocess Industry Summit

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“Platformization” has now become a normal. In the increasingly competitive context that lowering costs and improving productivity is a must,  market players are seeking to strengthen the process for high-yield, flexible and cost-effffective manufacturing. Continuous manufacturing (CM),  by virtue of potentially improving product quality, process stability and overall profifitability, is exerting a profound impact on changing the overall development trend of the biopharmaceutical manufacturing industry. 


According to the strategic plan issued by the US FDA in 2011, efffforts shall be made to gain the advantages of continuous process in development  and manufacturing, encourage the continuous manufacturing of biological products, and optimize the product quality by applying the QbD  (Quality by Design) concept. In the next decade, intelligent biological manufacturing will usher in its prominence by combining continuous  chromatography, automation, PAT, miniaturization, process enhancement, machine learning, digital twin, data analysis, etc. 


On November 17-18, the 4th Annual Bioprocess Industry Summit, jointly organized by East China University of Science and Technology,  Shanghai Society of Biotechnology (SSBT), Chinese Society for Microbiology and BioValley Club, will be held in Shanghai. As one of the  benchmark conferences of the biotechnology industry, this summit is themed with “Great technological Innovation leap tends”, aiming to  advance the development of the next generation of biopharmaceutical manufacturing process through exploring technological innovation in  the fifields of process development and strengthening of antibody drugs and cell & gene products as well as large-scale manufacturing, continuous manufacturing technology, and intelligent manufacturing, etc.


SUMMIT INFORMATION


Name: The 4th Annual Bioprocess Industry Summit

Theme: Great Technological Innovation Leap Tends

Time: November 17-18, 2022

Venue: Shanghai, China

Instructed by: Chinese Society for Microbiology

Organized by: East China University of Science and Technology,BioValley Club

Supported byShanghai Society of Biotechnology (SSBT)



 SUMMIT HIGHLIGHTS


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Summit Framework

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Selected Hot Topics

Antibody Upstream Processing

  • Relieving the tension between tradition and innovation in cell line development: site-directed integration technology

  • Selection and optimization of cell lines for multi-specific antibodies

  • Identifying bottlenecks in CLD: a simplified high-throughput approach

  • Study on cell culture process parameters and glycosylation by using the digital twin model

  • Characterization strategy of cell media and its challenge in commercial production

  • An efficient and reproducible method for optimizing culture medium

  • How to gradually introduce continuous flow technology at low cost in the traditional fed-batch cell culture process platform

  • How to achieve batch-to-batch consistency in multiple cell cultures

  • A case study of continuous upstream process: technical trends and quality considerations

  • Establishment and optimization of scale-down model through micro bioreactor


Antibody Downstream Processing and Formulation Development

  • Challenges of high-throughput protein purification and new process technologies

  • Development of virus removal process and considerations in process validation

  • Application of hydrophobic interaction chromatography (HIC) in purification of complex antibodies

  • Strategies for downstream process development of innovative nano-bodies

  • Process integration and enhancement by using the straight through processing (STP) system

  • Antibody polymerization behaviors that affect chromatographic process and efficiency

  • Challenge of bi-specific antibody impurities to downstream purification process

  • A case study – the establishment of the platform for developability and formulation preparation of bi-specific antibody molecules

  • Challenges and considerations in the development of high-concentration protein formulations

  • How to stabilize unstable molecules through formulation screening and process control

  • Strategies for quality control of complex glycoprotein

 

Cellular and Gene Therapy  Processing

  • Quality analysis and control of virus vector mediated gene therapy products

  • Development of non-viral gene vector and its application in gene therapy

  • Development of gene editing therapy based on transient delivery of VLP-mRNA

  • Strategies for economic development of vectors used in cellular and gene therapy

  • Influence of process plan design in the late stage of gene therapy system on the characterization of safety and effectiveness

  • Development and application of standard methods for in vitro/in vivo efficacy test

  • Strategies for the development of heterogeneous CAR-T processes and analytical methods

  • Strategies for TCR affinity optimization and safety evaluation

  • A study on freeze-thaw process and preparation stability of stock solution used for IND and BLA application

  • Processing technology and procedure optimization of cell sorting for quality improvement and cost reduction

  • Strategies for establishing a high-yield strain (GMP compliant) library

  • General technical requirements for quality control of gene therapy products and pharmaceutical research considerations


Commercial Production and “Intelligent” Manufacturing Trend

  • Challenge in industrialization and process scale-up: how to effectively and stably promote scale-up of pilot process

  • Analysis on key points of cell culture technology for AAV large scale manufacturing

  • Risky points and implementation control of co-manufacturing of stock solution

  • Considerations on regulatory and technical evaluation of pharmaceutical changes during clinical trials

  • Selection/control and change of pharmaceutical excipients

  • Risk analysis of technology transfer and transfer strategies– a case study

  • Quality control difficulties and strategies in the continuous manufacturing of antibody drugs

  • How to achieve continuous downstream processing based on tangential flow filtration (TFF)

  • A case study - Data-driven intelligent automation approach of biological manufacturing

  • Digital twins accelerate pharmaceutical process development and engineering


Guests to Be Invited

Bio-ONE 2021 Guests 


The 4th Annual Bioprocess Industry Summit

The 4th Annual Bioprocess Industry Summit


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Contact information of the organizing committee

The 4th Annual Bioprocess Industry Summit 2022 provides you with cost-effective and customized sponsorship solutions, if you hope to have a new product promotion plan in 2022, or you want to get close to the decision makers of pharmaceutical companies, then you must not miss our conference!


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

Contact: Abby

Mobile: 18217659261 (WeChat)

E-mail: xiaolang.jiang@biovalleyclub.com


Sponsorship seats are limited! There are not many star booths! Contact us now!

Review of previous sessions (2021)

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Organizer

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