Day One - Tuesday 11th October 2011

last modified: 20 October '11

8am

Registration and refreshments

9am

Chairman’s opening remarks:

› Mr Bill Helming,

Senior Vice President, PRTM

9.10am

Case Study - Manufacturing of the tetravalent DENVax vaccine

Generating long lasting immune response with the use of ‘virus backbone’
Manufacturing and clinical testing
Need for new approaches to vaccine manufacturing for infectious diseases

› Mr Joseph Santangelo,

Chief Operating Officer, Inviragen

9.40am

The Unit Vaccinology of the Netherlands Institute for Public Health and the Environment (RIVM) support for developing country manufacturers

What support is offered by the vaccinology unit?
Sustainable collaborations to ensure success in emerging markets
Different manufacturing platforms and how they are effectively implemented in developing markets with the help of RIVM

› Prof.dr. M.C.J.P. Claire Boog,

Head of Unit Vaccinology, RIVM/CIb, Netherlands Vaccine Institute

VACCINE MANUFACTURING PARADIGMS

10.10am

Development of large-scale manufacturing processes for modern live-viral vaccines for Dengue Fever

Viral vaccines – an ongoing important class of therapeutics in the pharmaceutical industry
Human Diploid cells and continuous mammalian cell lines for vial cultivation
Advantages and disadvantages of different manufacturing processes for viral vaccine production

› Ms Claire Malinowski,

Department of Industrial Operations, sanofi pasteur

10.40am

Morning refreshments

11.10am

Practical features of monolith chromatography for ‘Flu vaccine manufacturing

Fast methods development to cGMP manufacturing scale
Process economic improvements with monolith technology
General application with virus and DNA based vaccine products

› Mr Ales Strancar,

Managing Director, BIA Separations

11.40am

Quality by design in vaccine development and manufacturing

Developing robust manufacturing platforms for these vaccines that can be readily adapted each year within an existing regulatory framework
Traditional egg-based methods or emerging cell-based strategies
The use of QbD to enable process development of seasonal influenza vaccine manufacturing processes

› Ms Susan Dana Jones,

VP and Senior Consultant, BioProcess Technology Consultants

12.10pm

Panel session: advantages and disadvantages to modern vaccine manufacturing paradigms, the rise of cell culture and beyond

› Ms Claire Malinowski,

Department of Industrial Operations, sanofi pasteur

› Mr Joseph Santangelo,

Chief Operating Officer, Inviragen

› Ms Susan Dana Jones,

VP and Senior Consultant, BioProcess Technology Consultants

› Mr Ales Strancar,

Managing Director, BIA Separations

PLATFORMS AND SOLUTIONS FROM 2011 ONWARDS

12.55pm

Networking lunch

2pm

Key moves and focus areas for the vaccine manufacturing sector over the next decade – where are the priorities?

Focusing on chronic conditions such as cancer, auto-immune diseases and nicotine addiction
Recent reports suggest that therapeutic vaccines will significantly expand the vaccines market over the next decade – with cancer vaccines leading the field as the key focus area
What does the future hold for pandemic influenza vaccines? Assessing key immunological observations on clinical development

› Dr Vidadi Yusibov,

Executive Director, Fraunhofer Centre for Molecular Biotechnology

2.30pm

OncoVAX® Case Study – manufacturing a Sterile, Autologous Colon Tumour Derived Vaccine

Gaining FDA approval of OncoVAX®, an immunotherapeutic formulation composed of sterile, viable, irradiated, non-tumorigenic autologous tumour cells
Pharmacological challenges centred on the use of conventional drug product sterilization procedures.
Making manufacturing modifications to suit regulatory specifications, and overcoming these challenges

› Mr Michael G. Hanna Jr.,

Chairman and CSO, Vaccinogen

3pm

Design of scalable, single-use, and closed bioprocessing solutions: A new paradigm

How paradigm shifts in manufacturing platforms are affecting the global vaccines market today
How vaccine manufacturers can select the right bioprocessing solution to ensure success
How these new solutions and platforms can be applied to vaccine manufacturing in the ‘real world’

› Mr Sunil Mehta,

VP, Operations, KBI BioPharma

3.30pm

Selecting a good vaccine manufacturing platform in an emerging market

Strong growth of vaccines manufacturing capabilities within BRIC countries
Meeting needs of many stakeholders, health ministries and national regulatory authorities and increasing engagement of governments and donor foundations
Prudent selection to ensure long-term success and profitability
Balancing initial penetration with longer term economics and vaccine portfolios with emerging market needs - establishing a sustainable presence in emerging markets

› Mr Bill Helming,

Senior Vice President, PRTM

4pm