Time Topic
9:30-9:40 Opening
Brian Hosung Min, CEO, GenScript ProBio
Session 1: Cell and Gene Therapy CDMO
9:40-10:10 Accelerating CGT with robust and customized plasmid platform
Ming Ni, Principal Project Manager, GenScript ProBio

1. Plasmid for LVV
2. Plasmid for AAV
3. Plasmid for mRNA vaccine/drug
4. Plasmid for DNA vaccine/drug
10:10-10:50 Integrated one-stop solution for mRNA CMC
Xiao Pan, Director of Platform R&D Dept., GenScript ProBio

1. Introduction to ProBio integrated mRNA solution
2. mRNA CMC challenges and strategies
3. Platforms for IVT mRNA and LNP systems
4. Analytics and quality control considerations
10:50-11:10 Break
11:10-11:30 Reserved for invited speaker
Hyeong Cheol Kim, CTO, Curocell Inc.
11:30-12:00 Advanced one-stop gene therapy solutions
Ming Ni, Principal Project Manager, GenScript ProBio

1. Proprietary AAV packaging cell line: PowerSTM-293
2. Scalable AAV manufacturing processs
12:00-13:00 Lunch
13:00-13:30 Points to consider in the CMC study for IND application of biologics and cell and gene therapy drugs (online)
Sean Liour, VP of PM & RA Dept., GenScript ProBio

1. Introduction of the role of CMC study in the IND application.
2. The coverage of manufacturing process, product specification, analytical methods, and stability study at IND stage.
3. The control of adventitious agents
4. Potential differences of the CMC regulatory review practices between FDA and NMPA
Session 2: Biologics Discovery
13:30-14:00 Application of naïve Fab & VHH library in TAA antibody discovery for CAR-T & T-cell engager bi-specific antibody
Li Chen, Director of Biologics Discovery Dept., GenScript ProBio

1. Brief overview of tumor-associated antigen (TAA) and its therapeutic modality.
2. Solution of TAA antibody discovery using naïve library
3. Case study: anti-ROR1 VHH antibody in CAR-T & T-cell engager bsAb
14:00-14:30 Accelerated ADC development via integrated antibody discovery platform
Li Chen, Director of Biologics Discovery Dept., GenScript ProBio

1. Brief overview of history and current trending of antibody-drug conjugates.
2. Tools and strategies for naked antibody discovery for ADCs
3. Early-stage pharmacology evaluation of naked antibody for ADC application
4. Pharmacology assessment of ADC candidates
14:30-14:50 Break
Session 3: Biologics CDMO
14:50-15:20 Reserved for invited speaker
Sang Jeon Chung, CEO, AbTis
15:20-16:20 Overcome challenges in process development of bispecific antibody & recombinant proteins
Ying Li, Purification Process Development Director, GenScript ProBio

1. Introduction of ProBio Toolbox Platform
2. CMC challenges for bispecific antibody and recombinant protein
3. Toolbox solutions for cell line/cell culture/purification/formulation process development
4. ProBio PAD capability updates
16:20-16:30 Closing
Jihwan Rhee, Regional Commercial BD Head of AP1, GenScript ProBio

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