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Biochemical Engineering

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Vaccines Bioprocess Development and Commercialisation

Vaccines

Understand the challenges of creating a vaccine process.

30 May - 1 June 2018

This course will explore the critical issues at the various stages of vaccine development. International experts with over 10 years’ experience in their field will lead delegates in developing their understanding in the research, operational and regulatory challenges of the vaccine market.

The module explores risk based decision making for bioprocess analytics by considering why a measurement is being made and what it conveys with regard to product critical quality attributes.

Topics covered will include:
• Scale-up from lab to pilot scale.
• Quality by Design (QbD) as part of vaccine development.
• Expression systems.
• Single use platforms.
• Regulation and its impact on development.
• Final formulation and adjuvants.
• Developing worlds’s needs.

Who should attend?

This course is of interest to research scientists, programme managers,
process engineers and policy makers. The course is accessible to those new to vaccine development or those working in the field from business and academia.

• Specialised vaccines staff who would benefit from broadening their knowledge base
• Those new to vaccine development (recent graduates / research scientists)
• Project Managers, funders and policy-makers wanting to gain an understanding in vaccines.

Programme

Day 1

  • Vaccine Technology - Current issues and future challenges (Tarit Mukhopadhyay, UCL)
  • Understanding cost components and key drivers of IPV vaccine manufacturing employing different technologies in France or India (Martin Reers, Biological E Vaccines)
  • Conjugate Vaccine production (Steve Kolodziej, Pfizer Ltd.
  • Adjuvants and Formulation (Derek O’Hagan, GSK)
  • Process Development Challenges of novel vaccines (Sabine Gaillard, Sanofi)

Day 2

  • The quality control of human viral vaccines (Martin Wisher, BioReliance-SIAL)
  • Testing and control of adventitious agents (Stacy Springs, MIT)
  • QbD in Vaccine Development (Lee Smith, GreyRigge Associates)
  • Process Development and Regulation of Recombinant Vaccines (Barry Buckland, BioLogicB)
  • Analytical tools for 21st century vaccines (Indresh Srivastava, Sanofi)
  • Economic considerations for Vaccine Manufacturing (Yuki Abe, Biopharm Services)

Day 3

  • Innovative USP/DSP approaches to viral vaccines (Jose Castillo, Univercells)
  • Vaccines – Managing the complete life cycle (Alain Pralong, PC - Enable
  • Vaccine Commercialisation – Managing Change. A case study on the Live Attenuated Influenza Virus Vaccine (Matthew Downham, AZ/MedImmune)
  • Emergency Vaccines – A case study in Ebola (Sarah Gilbert, Jenner Institute, Oxford)

Module Leaders

Tarit Mukhopadhyay, UCL
Barry Buckland, BiologicB
Stacey Springs, MIT-CBI
Christopher Love, MIT

Previous Expert Speakers Include

Alan Calleja, BioPharm Services
Matthew Downham, MedImmune
Adrian Hill, Oxford University
Steve Kolodziej, Pfizer
Alain Pralong, Pharma-consulting Enable, fmr VP GSK
Andrew Sinclair, BioPharm Services
Indresh Srivastava, Protein Sciences Corp
Martin Wisher, BioReliance

A social networking event will be held for delegates and speakers

For further information and bookings please contact:
E: mbi-training@ucl.ac.uk
T: +44 (0) 20 7679 9619 I +44 (0) 203 549 5619

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