Introduction to Biopharma Industry

Biologics Regulation

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

Cell and Enzyme

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

Core Technologies of Therapeutics

• Gene therapy/Cell therapy
• Therapeutic antibody

Production of Recombinant Proteins in Prokaryotic Hosts

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

Production of Recombinant Proteins in Eukaryotic Cells

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

Cell Growth

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

How Vaccines Work

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

Vaccine Registration and International Cooperation

• Vaccine registration
• International Cooperation

Bioprocessing Basics & Aseptic Processing 

• 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

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

Downstream Processing

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

mRNA Medicines & LNP

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

Vaccine Manufacturing Process: DNA and mRNA

• DNA vaccines
• mRNA vaccines
• Case study

Bioprocessing Basics & Aseptic Processing

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

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

• 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)

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

Performance Qualification and Process Validation for Vaccine

• 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

Recent Trends in Vaccine Research and Development

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

Regulatory Affairs (RA)of Pharmaceutical in Korea

• Role of Government agencies
• Regulatory Affairs for Pharmaceuticals

ICH Guidelines

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

CMC (Chemistry, Manufacturing and Control)

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

Nonclinical Drug Development

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

Accelerated Approval of COVID-19 Vaccine during the Pandemic

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

Clinical Research Industry Trends and International Standards

• 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

• 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

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

Post Marketing Surveillance of Pharmaceuticals

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

Opening orientation & plasmid construction (Cloning)

Opening ceremony and safety orientation (LMO, MSDS), followed by the cloning workflow, including restriction digestion, agarose gel electrophoresis, DNA purification, ligation, agar plate preparation, and transformation

Colony screening & cell bank

Colony confirmation by colony PCR and agarose gel electrophoresis, followed by positive clone inoculation, MCB/WCB introduction, transformation, and overnight culture preparation

Seed culture & microbial identification

Preparation of seed culture from colonies and microbial identification through Gram staining, IMViC test, and API kit, followed by seed inoculation and shaking incubation

Bioreactor operation

Hands-on operation of a 7 L bioreactor, including COP/CIP, cleaning, sterilization, utility system checks, medium preparation, vessel setup, inoculation, and cultivation initiation

Cell harvest & lysis /  utility & pilot scale bioreactor

Harvest and downstream preparation, including cell recovery, centrifugation, homogenizer-based cell lysis, pellet handling, and utility/P&ID training for 70 L pilot-scale bioreactor operation

Protein purification (Chromatography)

Introduction to protein purification and preparation of buffers for cell pretreatment, followed by hands-on training with lab-scale chromatography systems for sample separation and column operation.

Column Packing

Column packing practice, including an overview of resin and column packing principles, hands-on column packing, and evaluation of packing efficiency.

Tangential flow filtration (TFF)

Introduction to tangential flow filtration (TFF), including system installation, flushing, pre- and post-NWP checks, UF/DF operation, and cleaning procedures.

Filter Integrity Test  (FIT)

Hands-on filter integrity test (FIT), including NFF cartridge filter and TFF filter preparation, installation, wetting, tester connection, and integrity tests such as diffusion, bubble point, and water intrusion tests.

Protein analysis

Preparation for aseptic filling

Fill-finish practical orientation, cleanroom gowning, and preparation for aseptic filling. Includes material disinfection, sterile filling preparation, and cleaning practices

Aseptic filtration & filling of insulin

Aseptic filtration and filling process for insulin products. Includes RABS and isolator systems, filling equipment, media fill concepts, and FMEA-based risk analysis

Product Inspection

Visual and automated inspection of filled products. Includes manual visual inspection, X-ray-based inspection, pH/osmolality testing, and UV-Vis-based preservative analysis

Aggregate Analysis

SEC-based aggregate analysis of insulin samples before and after filling. Includes evaluation of shear stress-induced HMWP formation and in-process quality assessment

Formulation & Characterization

Insulin formulation development and physicochemical characterization. Includes CD and DSC analysis for secondary/tertiary structure and biological comparability assessment

HPLC analysis

HPLC-based analysis and identity testing of recombinant insulin. Includes HPLC principles, standard/sample preparation, assay, and data analysis for QC

Microbiological safety & environmental monitoring

Microbiological safety testing and environmental monitoring. Includes sterility testing, microbial limit testing, surface monitoring, and airborne particle testing

Residual DNA quantification

qPCR-based purity and safety testing. Includes DNA extraction, qPCR setup, real-time PCR operation, Ct value analysis, and residual DNA quantification

Purity test (ELISA)

ELISA-based purity testing. Includes standard curve preparation, sample preparation, plate setup, absorbance measurement, and HCP concentration calculation

Endotoxin test & closing

Endotoxin testing by LAL assay, including sample pretreatment and endotoxin quantification, followed by final course evaluation (review of all QC results, data integration, quality judgment, final reporting, and practical assessment) and the closing (graduation) ceremony