Online Pre-Training
(3 weeks) |
Module 1: Basics for Biopharmaceutical and Bioprocess
- Introduction to Biopharma Industry
- Biologics Regulation
- Cell and Enzyme
- Core Technologies of Therapeutics
- Production of Recombinant Proteins in Prokaryotic Hosts
- Production of Recombinant Proteins in Eukaryotic Cells
- Cell Growth
- How Vaccines Work
- Vaccine Registration and International Cooperation
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Module 2: Vaccine Manufacturing Process
- Upstream Processing
- Downstream Processing
- mRNA Medicines & LNP
- Vaccine Manufacturing: DNA & mRNA
- Bioprocessing Basics & Aseptic Processing
- Formulation (Stability and Quality Control, Quality Issues for Advanced Products)
- Lyophilization(Freezed-drying, unit operation, cycle development, understanding and monitoring process)
- Performance Qualification and Process Validation for Vaccine
- Recent Trends in Vaccine R&D
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Module 3: Regulation of Biopharmaceuticals
- Regulatory Affairs(RA) of Pharmaceutical in Korea
- ICH Guidelines
- CMC (Chemistry, Manufacturing and Control)
- Nonclinical Drug Development
- Accelerated Approval of COVID-19 Vaccine during the pandemic
- Clinical Research Industry Trends and International Standards
- Drug Reimbursement & Health Technology Assessment in Korea
- The Korea Drug Approval–Patent Linkage System
- Post Marketing Surveillance
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Hands-on Training
at GBC
(2 Weeks) |
Week 1: Plasmid Construction and Fermentation
- Day 1: Opening Orientation & Plasmid Construction (Cloning)
- Day 2: Colony screening & Cell bank
- Day 3: Seed Culture & Microbial Identification
- Day 4: Bioreactor Operation
- Day 5: Cell Harvest & Lysis/ Utility & Pilot sclae bioreactor
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Week 2: Protein Purification
- Day 1: Protein Purification (Chromatography)
- Day 2: Column Packing
- Day 3: Tangential Flow Filtration (TFF)
- Day 4: Filter Integrity Test (FIT)
- Day 5: Protein Analysis
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Hands-on Training
at K-NIBRT
(2 Weeks)
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Week 3: Finalization (Fill & Finish)
- Day 1: Preparation for aseptic filling
- Day 2: Aseptic filtration & filling of insulin
- Day 3: Product Inspection
- Day 4: Aggregate Analysis
- Day 5: Formulation & Characterization
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Week 4: Bioanalysis for Quality Control
- Day 1: HPLC analysis
- Day 2: Microbilogical safety & environmental monitoring
- Day 3: Residual DNA quantification
- Day 4: Purity test (ELISA)
- Day 5: Endotoxin test & closing
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