Vaccine Manufacturing and Quality Control Processes

Students get an understanding of the concepts, methods and challenges of technical operations and quality of vaccine manufacturing.

Module's directors

Emanuele Montomoli, BSc, MSc, Full Prof.

President of the Master TSC, Full Prof. of Public Health
Dept. of Molecular and Developmental Medicine, University of Siena, Italy

Massimo Bugnoli, BioSc

OMV Operational Manager
GSK, Siena , Italy

Rahul Singhvi, ScD, MBA

Chief Operating Officer
Takeda Vaccines Inc, USA

Contents

See the lessons' list

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Lessons' List

Introduction to Module III
Short history of vaccines manufacturing
Differences between Pharma and Vaccines
Objectives of production
Fundamental pillars of manufacturing
Concepts in vaccines manufacturing, present and future
Process development
Quality Control
Technical transfer
Scale up
Cost of goods
Supply chain
Engineering
Analytical characterization and lot potency
Viral production (MMR)
Quality assurance / inspections
Regulations in Europe, USA, WHO
Animal facilities (Why, How)
Regulations
Bacterial production (Meningococcal)
Visit of GSK facility Rosia

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