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Antibody Manufacturing Process Hands-on Training
mRNA Bioprocess Hands-on Training

Antibody Manufacturing Process Hands-on Training

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Classification	Lecture	Contents	Equipments
Mammalian Cell Culture	5L Bioreactor Hands-on Traning (Bench-top)	Bioreactor Cultivation, Growth Curve DO, pH, temperature, rpm realationship practice 5L Pilot bioreactor Disassembly/Assembly	5L bioreactor
	50L Bioreactor Hands-on Traning (Wave)	Bioreactor Setup Bioreactor Filing Water-for-injection(WFI): Medium and Culture Fluid Replacement Utilization BioWelder and Tube Sealer Bioreactor Operation & Sampling	Peristaltic pump Bio-welder Tube sealer 50L Wave bioreactor
	200L Bioreactor Hands-on Traning (SUB Pilot)	Inspection of Disposable Bag (SUB) Tagging of SUB Lines and Components SUB Installation into Housing and Connection to Various Connector Skids Explanation of the Control System	200L SU Pilot Bioreactor
	Single-Use Technology	Disposable technology Understanding Functions and Performing Operations of Various Aseptic Conncetors, Peristaltic Pumps, Welders, and Sealers Bag integrity test Hands-on Practice for Air Injection into Disposal Bag (SUB) Using a Single-Use System Integrity Tester to Check for Flow Rate Changes and Bag Leaks	BioWelder TubeSealer Peristaltic pump Bag integrity tester
	Clarification (POD & Centrifuge)	POD Installation and Flushing Practice Understanding, Disassembly, and Assembly of Centrifuges Comparison of Tubular and Disk track centrifuge Tubular centrifuge Disassembly/Assembly	filter POD Tubular centrifuge Disk track centrifuge
Purification	Chromatography (Lab- scale)	Understanding and Operating Lab-scale Chromatography Systems	Lab scale chromatography system Chromatography Process Columns
	Understanding Chromatography (Process-scale) & Column	Understanding and Operating Process-scale Chromatography Systems Lab-scale column Disassembly/Assembly Understanding Pilot-scale column Understanding Column performance test	Chromatography Process Columns Chromatography Process system XK column
	Filter Integrity Test	Basic Explanation of Filter Integrity Testing Housing Disassembly/Assembly Hands-on Filter Integrity Testing	filter filter housing set Filter integrity tester
Drug Product	TFF	Fundamentals of Tangential Flow Filtration (TFF) Installation, Flushing, Pre-NWP Check Introduction to Lab-scale TFF system	UF/DF filter Lab-scale TFF system
	Bio-analysis for purification (UV)	Understanding Concepts and Process Parameters for the Filing Process (RABS, Isolator, Filing Mechanism) Filling Process Hands-on Practice and Post-filling Net Content Test	Solo VPE
	Aseptic gowning	Aseptic gowning procedure Entry/Exit Procedures for Clean Areas
	Aseptic filling	Understanding Concepts and Process Parameters for the Filing Process (RABS, Isolator, Filing Mechanism) Filling Process Hands-on Practice and Post-filing Uniformity Test	Filling machine mVROC
	Understanding Lyophilization Equipment and Principles	Introduction to Lyophilizer Equipment and Principles (Components, CIP, SIP)	Lyophilizer
Bioanalysis	Environment monitoring	Environmental Monitoring Methods, Procedures, and Frequency Airbone Particle Analysis Procedures and Hands-on Practice Settling Plate Analysis Procedures and Hands-on Practice	Particle Counter Active air monitoring
	Bioburden Test	Overview of Bioburden Test and Specific Microbial Tests Bioburden Test (Membrane Filter Method, Agar Plate Method)	Manifold Vaccum Pump Biosafety Cabinet
	Insoluble matter and Foreign particles	Visual Inspection for Particulates and Evaluation of Insoluvle Particulate Matter	Visual Inspection Booth HIAC Flowcam
	HPLC Analysis	HPLC Principles and Theory Substance Analysis using HPLC HPLC Method Development	HPLC

mRNA Bioprocess Hands-on Training

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Classification	Lecture	Contents	Equipments
Microbal Culture	Transformation (E.coli + plasmid)	Overview of the weekly Fundamental Characteristics and Applications of mRNA & E. coli Cell Bank Management/ Glycerol stock Transformation(E.coli+ plasmide) Genetic Transformation [Hands-on: Heat Shock Transformation] Chemical Transformation Electroporation Thawing cryovials incubator cell culture	Autoclave BSC Deep freezer
	Lab-bio reactor	Equipment Preparation (Bioreactor Assembly, Sensor Calibration) Basic structure (P&ID)/Lab bioreactor operation (disassembly and assembly) Process flow diagram (PFD) 200 mL seed media preparation inoculation	Lab Bio reactor Microscope BSC Incubator
	Gram staining, IMViC Test	Microbiome Assessment Gram staining/ IMViC Test	Gram staining IMViC test
	Pilot Bio reactor	Pilot-scale Bioreactor Operation (50 L) Inoculation, sampling , and measuring Basic structure (P&ID) Harvest preparation	Pilot bioreactor
	Centrifuge and Cell distruption	Centrifugation : Comparison of Tubular, Disk stack and Laboratory Rotor Methods 5L Lab Bioreactor Harvesting, Operation of Laboratory Centrifuge, and 5L culture pallet (cake) Harvesting Cell Lysis : Homogenizer Operation	Centrifuge Homogenizer Lab Bio reactor
Purification	Filter integrity test	Filter Integrity Test (FIT) Introduction of FIT Installation, wetting and operation of FIT	Filter integrity tester
	Chromatography system understanding	Chromatography system Introduction & operation of chromatography system (lab-scale) Operation of the system (process-scale)	Lab-scale chromatography system Process-scale chromatography system
	pDNA Purification	Technical Background and Basic Protocols for plasmid DNA Purification Plasmid isolation and purification Quantification of plasmid DNA	Horizontal electrophoresis system
	In Vitro Transcription	In vitro transcription pDNA linearization Gel electrophoresis	Horizontal electrophoresis system
Drug Product	Aseptic filling	Pre-filled syringe fill finish Restricted access barrier system for aseptic process Aseptic simulation Deliverable volume test	Filling machine Balance
	mRNA-LNP manufacturing	mRNA-LNP manufacturing Microfluidics mixing/Impingement Jets Mixing Particle size and distribution using DLS	KNAUER IJM NanoScaler NanoAssemblr™Ignite™
	mRNA-LNP quality evaluation 1	mRNA-LNP quality evaluation Encapsulation efficacy of mRNA using Ribogreen Quantification of mRNA-LNP using NTA	Microplate reader
	mRNA-LNP quality evaluation 2	mRNA-LNP lipid quantification HPLC-ELSD Critical process parameter	HPLC-ELSD
	CFF hands-on Training	Understanding CFF process by using manual and small scaled CFF system Protein concentration Buffer exchange	Manual Assembly
Bioanalysis	Microbial Test 1	Microbial Test 1 Microbial contamination control Rapid microbial test Microbial identification test	Microbial limits test pump Rapid microbial test system Rapid microbial test system
	Analytical Testing	Capillary electrophoresis Sample and mobile phase preparation Capillary electrophoresis introduction & analysis method Data analysis	Capillary electrophoresis
	Microbial Test 2	Microbial Test 2 Endotoxin test – kinetic chromogenic assay Calibration curve & reliability Test for interfering factors	Microplate reader Multipette
	Microbial Test 3	Microbial Test 3 Bioburden test introduction Membrane filter method	Manifold Vacuum pump