Introduction to Biopharma Industry (1h)

Biologics Regulation (2h)

• Regulatory needs and related regulations
• Definition, characteristics, and types of biopharmaceuticals
• Biosafety introduction

Cell and Enzyme (3h)

• Microbial diversity
• Biomolecules and nucleic acids
• Function, kinetics, and immobilized system of enzyme

Core Technologies of Therapeutics (3h)

• Gene therapy/Cell therapy
• Therapeutic antibody

Production of Recombinant Proteins in Prokaryotic Hosts (3h)

• Regulating transcription
• Increasing protein stability and secretion
• Facilitating protein purification

Production of Recombinant Proteins in Eukaryotic Cells (3h)

• Post-translational modification
• Yeast expression system
• Protein engineering

Cell Growth (3h)

• Quantifying cell growth, Quantification of product
• Fermentation data
• Continuous manufacturing

How Vaccines Work (3h)

• Principle of vaccination immunity
• Classification of vaccine
• Mechanism of vaccine

Vaccine Registration and International Cooperation (3h)

• Vaccine registration
• International Cooperation

GMP for Biopharmaceuticals (3h)

• Introduction of GMP for biopharmaceuticals
• GMP for manufacturing
• GMP for quality: QA, QC

Bioprocessing Basics & Aseptic Processing (3h)

• Aseptic process overview
• FDA guide to aseptic processing
• Aseptic Technique and HAI(Healthcare Associated Infections)
• Preventing infections using aseptic technique
• Aseptic field management

Upstream Processing (3h)

• Bioprocessing for biopharmaceutical manufacturing
• Cell line generation
• Upstream bioprocess

Downstream Processing (3h)

• Introduction of downstream processing
• Harvest
• Chromatography
• Tangential flow filtration
• Virus inactivation and virus clearance

mRNA Medicines & LNP (3h)

• mRNA Vaccine & carrier
• mRNA-LNP formulation & production I
• mRNA-LNP production II & Analysis

Vaccine Manufacturing Process: DNA and mRNA (3h)

• DNA vaccines
• mRNA vaccines
• Case study

Formulation (Stability and Quality Control, Quality Issues for Advanced Products) (3h)

• Backgrounds on dosage form and drug product
• Formulations and stability with analytical tools
• Quality of injectables – visible & subvisible particles

Lyophilization (Freeze-drying, Unit Operation, Cycle Development, Understanding and Monitoring Process) (3h)

• Process definition
• Unit operations/Lyo-cycle and monitoring
• Process understanding and quality

Performance Qualification and Process Validation for Vaccine (3h)

• Process qualification and process validation for vaccine
• Process development for vaccine
• What is QbD (Quality by Design)?
• Applying quality by design to vaccines
• Critical process parameters, Critical quality attributes

Vaccine Manufacturing Process: Drug Product (DP) (Fill and Finish) (3h)

• Compounding
• Filling
• Aseptic process simulation

Recent Trends in Vaccine Research and Development (3h)

• Vaccine paradigm shift after COVID-19
• Vaccine development: Korean perspective
• Global perspectives on future vaccines

Biopharmaceutical Regulatory Affairs (RA) in Korea (2h)

• Role of Government agencies
• Regulatory Affairs for Pharmaceuticals

ICH Guidelines (4h)

• Overview, Practice in Korea
• Efficacy/Safety guidelines
• Quality/Multidisciplinary guidelines
• ICH M9: Biopharmaceutics Classification System-based biowaivers

CMC (Chemistry, Manufacturing and Control) (4h)

• Overview of drug development process
• Understanding the importance of CMC
• CMC readiness for IND and BLA (NDA)
• Developing CMC strategy and management

Pharmacopeial and International Collaboration (2h)

• USP-NF Overview/ How to use USP-NF/ Standard setup and available resources/ Pharmacopeial and international collaboration
• USP Biologics / mAb standards and resources / Vaccine

Nonclinical Drug Development (4h)

• New Drug Modality
• Nonclinical Study
• Nonclinical Pharmacology Study
• Nonclinical Toxicology Study

Accelerated Approval of COVID-19 Vaccine during the Pandemic (1h)

• Clinical development of COVID-19 vaccine
• Equitable access & broad distribution to the global
• Korea examples

Clinical Research Industry Trends and International Standards (4h)

• Global and Korea Clinical Research Industry Trends
• ICH GCP(E6) and Relevant Guidelines
• Regulation & Guideline for Clinical Research in Korea
• IND Submission & Approval Process in Korea

Drug Reimbursement and Health Technology Assessment in Korea (3h)

• National Health Insurance System/ Drug reimbursement in the NHIS
• Health Technology Assessment in NHIS(1,2)
• Post-listing policies/ Lessons from HTA in Korea

The Korea Drug Approval-Patent Linkage System (3h)

• Introduction to Korean Patent Law
• The Korea Drug Approval-Patent Linkage(1,2)

Post Marketing Surveillance of Pharmaceuticals (3h)

• Pharmacovigilance and spontaneous adverse event reporting
• Signal detection and case examples
• Status of PV system in Asia-Pacific countries

• Introduction to Gene Transformation (Chemical-transformation, Electro-transformation)
• Microbial Subculture (Liquid, Solid Media) Transformation (E.coli + Plasmid) Stock - Media Preparation

• Equipment Preparation (Reactor Assembly, Sensor Calibration)
• Basic structure (P&ID)/Lab bioreactor operation (disassembly and assembly)
• Process flow diagram (PFD)

• Microbiome Assessment
• Gram staining/IMViC test

• Equipment Preparation
• 5L lab reactor assembly, sensor calibration
• 200ml seed media preparation inoculation

• Single Use Operation
• Basic structure, operation practice
• Welder, Sealer, SUB-Bag Leak Integrity

• Pilot-scale bioreactor operation (50 L)
• Inoculation, sampling, and measuring
• Basic structure (P&ID)
• Harvest preparation

• Centrifuge (Lab-scale Centrifuge, Pilot-scale Centrifuge)
• Cell disruption (homogenization)
• Centrifuge operation (disassembly and assembly)

Technical Background and Basic Protocols for pDNA Purification & In Vitro Transcription

• Plasmid isolation and purification
• Quantification of pDNA

In vitro transcription

• Restriction enzyme digestion
• In vitro transcription
• Gel electrophoresis

Chromatography System

• Separation technology for bioprocesses
• Introduction & operation of chromatography (lab-scale)
• Operation of the system (process-scale)
• Chromatography Column Packing and evaluation
• Preparation resin slurry
• Column packing
• Evaluation of the column packing
• Unpacking a column

Tangential Flow Filtration (TFF)

• Installation and operation of small UF/DF
• Operation of TFF system

Filter integrity test

• How to check filter integrity
• Trouble shooting sterile filter integrity inspection

Cleanroom gowning

• Principle of cleanroom
• Gowning procedure
• Gowning qualification

Microbial Test 1

• Bioburden test introduction
• Membrane filter method

Capillary electrophoresis

• Sample and mobile phase preparation
• Capillary electrophoresis introduction & analysis method
• Data analysis

Microbial Test 2

• Endotoxin test – kinetic chromogenic assay
• Calibration curve & reliability
• Test for interfering factors

mRNA-LNP manufacturing process

• Microfluidic chips
• Impingement Jets Mixing (simulation)

LNP Characterization

• Encapsulation Efficacy
• Particle size & Size distribution

LNP lipid quantification

• HPLC operation
• ELSD detector principle
• Lipid quantification

Aseptic filling

• Restricted access barrier systems
• Air sampling using settle plates
• Glove microbial monitoring by contact plates

Microbial Identification

• Extract DNA
• PCR & Cycle sequencing
• Sequence the DNA
• Identify the organism

• K-VCAST tour
• Introduction of K-VCAST and responsibility Site tour
• Overview of Vaccine Quality Control

K-Bio or MFDS tour

• Introduction of K-Bio or MFDS
• Role of K-Bio or MFDS
• Site tour

Expert Talk about Quality Affairs or Regulatory Affairs

• Conversations between experts and trainees on specific topics

Utility system for biomanufacturing

• Yonsei University Severance Hospital Tour at Shinchon Campus, Yonsei University
• Completion Ceremony with Banquet