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Curriculum

Antibody Bioprocess Training Program
Vaccine Bioprocess Training Program
Academic Program
Faculty Introduction
Pilot training and education space

Vaccine Bioprocess Training Program

Overview of Vaccine-Specialized Education
Detailed curriculum
Enrollment

Theory Course

Biotechnology I : Basic theory course
Subject Main content
Day 1 Introduction of biopharmaceuticals
  • - The advent of molecular biotechnology
  • - Small molecules vs. biopharmaceuticals
  • - Biotechnology and Biopharmaceuticals (NOA)
Basic life science
for bioprocessing I
  • - Cell structure and function
  • - Microbial diversity and cell evolution
  • - Major intracellular metabolic pathway
  • - Cell Biology and Recombinant DNA Technology (NOA)
Day 2 Basic life science for bioprocessing II
  • - Structure of nucleic acids
  • - Gene expression
  • - Control of gene expression
  • - Protein structure and function
Day 3 Basic core technology
for bioprocess
  • - Recombinant DNA technology
  • - Cell Biology and Recombinant DNA Technology (NOA)
  • - CRISPR
  • - PCR
  • - Omics (genomic science)
Day 4 Biopharmaceutical development
  • - Candidate substance discovery
  • - Overview of the Biopharma Industry and Products (NOA)
  • - Drug development (non-clinical/clinical)
  • - Overview of the Biopharma Industry and Products (NOA)
Day 5 Production of recombinant proteins
  • - Bacterial protein production
  • - Eukaryotic protein production
  • - Protein engineering
Analysis of biopharmaceuticals
  • - Quality management
  • - Analysis technology
  • - Process Validation1: Process Design (NOA)
  • - Process Validation 2: Process Qualification and Control (NOA)
Biotechnology II: advanced and required course
Subject Main content
Day 1 Career development in the biopharmaceutical industry
  • - Specialty development: What will you prepare?
  • - The future of the biopharmaceutical industry
Molecular diagnostics
  • - Immunological detection of protein biomarkers
  • - DNA-based diagnostics
  • - Detection of RNA characteristics of diseases
  • - Biofluorescence and Bioluminescence Systems
Regulation of biopharmaceuticals
  • - Bio-safety education (BSL 1~4)
  • - Biopharmaceutical approval process
  • - CTD preparation and submission
  • - Biotechnology patents
Day 2 Protein therapies
  • General protein therapies
  • - Lymphokine, hormone, growth factor, enzyme, and protein inhibitor
  • - Biosimilars and biobetters
  • Therapeutic antibody
  • - Antibody fragments
  • - Full-length antibodies
  • - Shuffling CDR sequences
  • - Dual variable domain antibody
  • - Antibody half-life enhancement technology
Day 3 Nucleic acid therapeutics
  • - Targeting specific mRNA & DNA sequences
  • - Virus delivery system; non-virus delivery system
  • - Gene therapy
  • - RNA therapeutics
  • - Introduction to Gene Therapy (NOA)
Cell therapy
  • - Introduction to Cell Therapy (NOA)
Vaccine
  • - Vaccination, subtype vaccine, peptide vaccine, genetic immunization (DNA & mRNA vaccine), attenuated vaccine, vector vaccine, monoclonal antibody passive immunization, and COVID vaccine
  • - Introduction to Viruses (free) (NOA)
  • - Vaccine and Immunity (free) (NOA)
Day 4 Bioprocess I
  • - Overview of process validation and design
  • - Unit process and Mass & Energy Balance
  • - Overview of GEP and utilities
  • - Overview of Biopharmaceutical Manufacturing (NOA)
  • - Bioprocess overview
  • - Upstream process
  • - Filtration Process Development (NOA)
  • - Understanding Upstream Bioprocessing (NOA)
  • - Upstream Processing: Bioreactors in Bioprocessing (NOA)
Day 5 Bioprocess II
  • - Fermentation in Biopharmaceutical Manufacturing (NOA)
  • - Bioreactor Operations (NOA)
  • - Cell Culture in Biopharmaceutical Manufacturing (NOA)
  • - Downstream process
  • - Downstream Processing (Centrifugation, Ultrafiltration and Diafiltration, Protein Purification – Chromatography) (NOA)
Biotechnology III: Vaccine-specialized theory course
Subject Main content
Day 1 Introduction to A-Vax & CQA
  • - A-Vax Case Study and QbD
A-Vax Control Strategy
  • - Process Validation Issues
Day 2 A-Vax Polysaccharide
  • - Upstream Process Validation
A-Vax VLP
  • - Upstream Process Validation
Day 3 A-Vax Downstream
  • - Downstream Process Validation
A-Vax DP, Formulation
  • - Formulation, Adjuvant, Endotoxin, Particulate Matter in Injectable Drug
Day 4 QbD, Design Space
  • - Design Space, PAR, Documentation
Implementation
  • - RA, ROI, Economic evaluation
Day 5 AVV vs. mRNA Vaccine
  • - DNA & mRNA Vaccine Process
Lyoprocess development
& optimization
  • - Quality in Lyophilization Process (Tc, Tg, TEU in Analysis)

Practice Course

Culture
  1. (1) Upstream Processing Operations
  2. (2) Single Use Technologies in the Biopharmaceutical Industry
Purification
  1. (1) Downstream Processing Operations
Finished
  1. (1) Fill Finish Operations
  2. (2) Lyophilisation for Biopharmaceutical Fill-Finish Operations
Analysis process
  1. (1) Navigating QC Testing for Biologics and Biosimilars
  2. (2) QC Micro Skills for Biopharma
Utility
  1. (1) Bioprocessing for Non-Scientists
  2. (2) Bioprocessing for Engineers
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