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International Training

Global training institute for professional manpower leading the bioindustry

International Training

Training Information

2025 Hands-On Training for mRNA Vaccine Manufacturing

Organized by the Global Training Hub for Biomanufacturing (GTH-B) in the Republic of Korea,
supported by the World Health Organization (WHO) and IFEZ (Incheon Free Economic Zone)

Training Objectives

Acquire advanced hands-on skills for mRNA vaccine manufacturing
Strengthen vaccine production capabilities at participants’ home institutions
Deepen understanding of tailored bioprocessing and regulatory affairs
Build international networks for collaboration in biomanufacturing

Training Schedule and Location

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Phase	Period	Location	Content Description
Online Pre-Training	Sept 1 – Sept 19, 2025 (3 weeks)	Online	3 modules of online lectures and written Q&A
On-site Practical Training	Nov 3 – Nov 21, 2025 (3 weeks)	K-NIBRT (Incheon)	Hands-on mRNA vaccine manufacturing practice and site-specific training
Site Visits & Wrap-up	Nov 24 – Nov 28, 2025 (1 week)	K-VCAST (Hwasun), K-Bio/MFDS (Osong), K-NIBRT (Incheon)	Facility tours, regulatory insights, networking

※ The training schedule is subject to change depending on circumstances.

Detailed Training Modules

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Classification	Contents
Online Pre-Training (3 weeks, 90 Lectures)	Module 1: Biotechnology General (30 Lectures) Day 1: Introduction to Biopharma Industry / Biologics Regulation / Cell and Enzyme Day 2: Core Technologies of Therapeutics / Recombinant Proteins in Prokaryotic Hosts Day 3: Recombinant Proteins in Eukaryotic Cells / Cell Growth Day 4: How Vaccines Work / Vaccine Registration and International Cooperation Day 5: GMP for Biopharmaceuticals
	Module 2: Bioprocess General (30 Lectures) Day 1: Bioprocessing Basics / Aseptic Processing / Upstream Processing Day 2: Downstream Processing / mRNA Medicines & LNP Day 3: Vaccine Manufacturing – DNA & mRNA / Formulation Day 4: Lyophilization / Process Validation for Vaccine Day 5: Vaccine Manufacturing Process (Fill & Finish) / Trends in Vaccine R&D
	Module 3: Introduction to Regulatory Affairs (30 Lectures) Day 1: Biopharmaceutical Regulatory Affairs in Korea / ICH Guidelines Day 2: CMC (Chemistry, Manufacturing and Control) / Pharmacopeial and International Collaboration Day 3: Nonclinical Drug Development / Accelerated Approval of COVID-19 Vaccine Day 4: Clinical Research Industry Trends / Drug Reimbursement & HTA in Korea Day 5: Korea Drug Approval–Patent Linkage System / Post Marketing Surveillance
Hands-on Training at K-NIBRT (3 Weeks)	Week 1: Fermentation Day 1: Introduction to Gene Transformation Day 2: Equipment Preparation / Basic Structure / Lab Bioreactor Operation / Process flow Diagram Day 3: Microbiome Assessment / Equipment Preparation Day 4: Single Use Consumable & Pilot-scale Bioreactor Operation Day 5: Centrifuge Operation & Cell Disruption
	Week 2: RNA Synthesis & Purification Day 1: Technical Background and Basic Protocols for pDNA Purification & In Vitro Transcription Day 2: In Vitro Transcription & Gel Electrophoresis Day 3: Chromatography System & Column Packing and Evaluation Day 4: Tangential Flow Filtration (TFF) – Installation, Operation, and Buffer Exchange Day 5: Filter Integrity Test
	Week 3: Finalization (Fill & Finish) & Bioanalysis for Quality Control Day 1: Cleanroom Gowning & Microbial Test 1 – Bioburden Test Day 2: Capillary Electrophoresis & Microbial Test 2 – Endotoxin Test Day 3: Microbial Identification – DNA Extraction, PCR, and Sequencing Day 4: mRNA-LNP Manufacturing Process & LNP Characterization Day 5: LNP Lipid Quantification & Aseptic Filling
Site tour and Utility System (1 Week)	Site/Utility Tour of several Institution Expert Talk about Regulatory Affairs

※ 3 Modules includes written Q&A session for each module. ※ Training schedule and curriculum are subject to change depending on circumstances.

Contact Information

For further questions related to this, please contact the course coordinator at gthb@gthbsf.org
After the selection process, K-NIBRT will be responsible for answering further questions.

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Name	Position	Email Address	Phone
Kyungkoo Kim	Manager, International Training (Main Contact Point)	kk_kim@yonsei.ac.kr	+82-32-713-9836
Hyojin Lim	Senior Manager, Education Development and International Training	hj.lim@yonsei.ac.kr	+82-32-713-9827