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Biotechnology I
Biotechnology II
Biotechnology Ⅲ
Biotechnology Ⅳ
Biotechnology Ⅴ

Biotechnology I: Biopharmaceutical Basics and Bioprocesses

Classification	Contents
Introduction to Biopharma Industry	The present and future of the biopharmaceutical industry What will you do to prepare for your professional development?
Biologics Regulation	Regulatory needs and related regulations; including the Pharmaceutical Affairs Act 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 translation efficiency Increasing protein stability and secretion Facilitating protein purification; integrating DNA into the host chromosome
Production of Recombinant Proteins in Eukaryotic Cells	Post-translational modification; general features of eukaryotic expression systems Yeast expression systems; mammalian cell expression systems 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
GMP for Biopharmaceuticals	Introduction of GMP for biopharmaceuticals GMP for manufacturing GMP for quality: QA, QC
QC and Analysis of Biopharmaceuticals	Quality control Analytical testing Analytical methods

Biotechnology II: Antibody Manufacturing Process

Classification	Contents
Introduction to Antibody Drugs	Mechanism of action and functions of antibodies Principles of antibody immunity Classification of antibodies
Key Technologies in Antibody Drug Development	Antibody treatments: Antibody fragments, Full-length antibodies CDR sequence grafting Bispecific antibodies Antibody half-life extension technologies
Regulatory Approval and International Coopreation	Regulatory approval for antibody drugs International Cooperation
Biologics Production Process1 : Upstream Processing	Bioprocessing for the manufacturing of biologics Cell line development Upstream and downstream process
Biologics Purification Process1 : Downstream Processing	General Description of downstream purification steps for biologics Harvest process (Depth filtration, Centrifugation) Principles of various chromatography techniques used for protein purification Basic principles of anion and cation exchange chromatography Principles of virus inactivation and removal
Purification Process Strategy and Scale-up	Antibody purification process design using platform processes Chromatography scale-up for large-scale manufacturing Requirements for successful chromatgraphy technology transfer - purification process troubleshooting
Formulation/ Fill-Finish	Formulation and excipients Filling process Isolator/barrier technology Stability and quality control Product quality issues
Lyophilization	Unit operation Lyophilization process design and monitoring Process understanding
Drug Product Manufacturing Process for Biologics	Introduction Aseptic manufacturing process Drug product manufacturing process
Antibody Manufacturing Process : Packaging and Finalization	Aseptic Process simulation, APS Filling Packaging and labeling

Biotechnology III: Vaccine Bioprocessing

Classification	Contents
Bioprocessing Basics & Aseptic Processing	Overview of biopharma manufacturing Aseptic process overview. aseptic process simulation FDA guide to aseptic processing
Upstream Processing	Fermentation, cell culture Bacterial cell culture media, design and optimization of cell culture processes Mammalian cell culture media, design and optimization of cell culture processes
Downstream Processing	Chromatography Virus inactivation and viral clearance TFF
mRNA Medicines & LNP	mRNA medicines Lipid nanoparticles (LNP)
Vaccine Manufacturing Process: DNA and mRNA	DNA vaccines mRNA vaccines Case study
Formulation (Stability and Quality Control, Quality Issues for Advanced Products)	Introduction of biopharmaceuticals and vaccines & formulation development Protein stability and route of administration for protein therapeutic Quality of injectables & quality evaluation (LNP)
Lyophilization (Freeze-drying, unit operation, cycle development, understanding and monitoring process)	Unit operations Lyo-cycle and monitoring Process understanding
Performance Qualification and Process Validation for Vaccine	Process development for vaccine Quality-by-design (QbD) of vaccine manufacturing process parameter Critical process parameter (CPP), key process parameter (KPPs), critical quality attribute (CQA)
Vaccine Manufacturing Process: Drug Product (DP) (Fill and finish)	Aseptic process simulation/compounding Filling Packing and labeling
Recent Trends in Vaccine Research and Development	Vaccine Paradigm Shift after COVID-19 Vaccine Development: Korean Perspective Global Perspectives on Future Vaccines

Biotechnology IV: Cell & Gene Therapy

Classification	Contents
Immunology of Cell and Gene Therapy	Cells of the Immune System Immune Responses Antibody & T cell Receptor
Nanoscience and Nanotechnology for Cells and Genes	Introduction of Nano Science and Nonotechnology Cell Biology and Nonomedicine Nanomaterial-based Drug Delivery Systems, Devices and Drug Development
CAR-T Cell Therapy	Introduction of Cancer Immunotherapy What is a CAR-T Therapy Applications of CAR-T Therapy in Hematologic Malignancy Current Challenges of CAR-T Therapy What is the Next Conclusion
Manufacturing Process and Quality Control of Stem Cell and Gene Therapies	CDMO Act on the Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals Manufacturing Management for Cell/Gene Therapies
Gene Therapy	Quality Control of Advanced Biopharmaceuticals Considerations for Quality Testing in Advanced Biopharmaceutical Development Testing Methods for Gene(CAR) Introduction Technology-based Therapeutics
Manufacturing Process of Adeno-Associated Virus(AAV) Vector for Gene Therapy	Stem Cell and Gene Therapy Overview GMP Manufacturing Process for Stem Cell Therapeutics GMP Quality Testing for Stem Cell Therapeutics

Biotechnology V: Regulation of Biopharmaceuticals

Classification	Contents
Regulatory Affairs (RA) of Pharmaceutical in Korea	Role of Government agencies Regulatory Affairs for Pharmaceuticals Health and Welfare related Affairs
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
Pharmacopeial and International Collaboration	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	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

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