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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 by: Shanghai Society of Biotechnology (SSBT)
SUMMIT HIGHLIGHTS
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
Bio-ONE 2021 Guests
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!
