★ New targets of antibody and transformation progress
★Experience of design new antibody sequences
★New toxin and coupling strategy of ADC
★Druggability of novel antibody
Who would attend:
★Management of biopharmaceutical and biotechnology companies: Head of early R&D, mechanism research, drug discovery, project survey department
★PI from Universities, research institutions and hospitals: Scientist majored in pharmacy, translational medicine, biology and life science
Cell Therapy CMC Research
What you will learn:
★ Latest interpretation of CMC review for cell therapy
★Constructing production specifications and quality system for cell therapy and virus
★Requirements of quality analysis and control for cell therapy drug release
★Optimization strategies for upstream, downstream and preparation of cell therapy drug to shorten and simplify the process
Who would attend:
★Head of CMC, process development, quality research/analysis, manufacturing and technology department from cell therapy companies
★Head of process development, manufacturing, technology and quality analysis department from CDMO
Regulation and Design of Biopharma Clinical Trials
What you will learn:
★Latest preclinical and clinical requirements and guidelines after entering ICH
★Latest policy of ethics, genetics office and new clinical operation strategies
★Experience about how to build a leading clinical quality management system
★Application of cutting-edge clinical analysis methods and clinical data management technologies
Who would attend:
★Head of preclinical R&D, pharmacology, toxicology, clinical R&D, clinical medicine, clinical operation and bioanalysis department from biopharmaceutical companies
★Head of clinical quality, RA department from biopharmaceutical companies
★HCP, doctors from clinical trial companies, CRC
★Supervisor and regulator
Novel Antibody Upstream Bioprocessing
What you will learn:
★ Process development and amplification of perfusion in upstream
★Optimization strategies of cell bank and medium
★Continuous integrated process in upstream and downstream
★Characterization and optimization of upstream fermentation process to increase yield and shorten process
Who would attend:
★Head of cell line construction and cell culture department
★Head of upstream process development department
★Head of upstream process amplification department
★Head of pilot scale upstream process development department
★Head of production technology department
Novel Antibody Downstream Bioprocessing
What you will learn:
★ Downstream purification process of new complex antibody
★Application of continuous technology in downstream purification
★Identification and removal process of new antibody related impurities
★Amplification of high-throughput purification process and key points of quality control
Who would attend:
★Head of downstream process development department
★Head of downstream process development department
★Head of pilot-scale downstream process development department
★Head of coupling and assembly
★Head of preparation department
★Head of quality analysis department
Modified Recombinant Protein R&D
What you will learn:
★ Experience of platform development for recombinant proteins
★R&D strategy for recombinant proteins’ long effectiveness
★R&D of new generation domestic cytokines, insulin and peptide drugs
Who would attend:
★Head of R&D department from biopharmaceutical and biotechnology companies working on recombinant proteins
BioManufacturing and Quality Management
What you will learn:
★ Requirements of quality for BLA tracking and reporting
★Constructing GMP quality system for production of international biologics
★Design and construction of biopharmaceutical plant
★Cutting-edge biopharmaceutical production strategy and experience of risk control and management
Who would attend:
★Management of biopharmaceutical and biotechnology companies working on cell therapy
★Head of manufacturing, technology and QA/QC department from biopharmaceutical companies
★Head of manufacturing, technology and QA/QC department from CDMO
