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08:50 - 09:00 10 mins
Chairperson's Opening Remarks
09:00 - 09:30 30 mins
Biomanufacturing Has Matured from a Key Enabler to a Value Driver, So What’s Next?
  • Jorg Thommes - Senior Vice President Engineering & Technology, Biogen Inc., USA

Productivity and operational reliability of recombinant protein and antibody manufacturing have matured to an extent that Drug Substance manufacturing could almost be considered commoditizes. However, there new frontiers in biomanufacturing that will need substantial technology development. In this presentation, we will discuss emerging needs in biomanufacturing, e.g. further industrialization of antibody manufacturing (buzzword Industry 4.0), accelerated manufacturing for early clinical testing, and manufacturing for new therapeutic modalitie

09:30 - 10:00 30 mins
Adapting Bioprocessing Strategies and Technologies for Next Generation Therapies
10:00 - 10:45 45 mins
Morning Coffee and Poster Tour 1 (3 Posters - 30 Minutes)
10:45 - 10:50 5 mins
Chairperson's Opening Remarks
  • Dan Adams - Executive Chairman and Global Head of Business Development, Protein Sciences Corporation, USA
10:50 - 11:20 30 mins
Adventures in Securing FDA Approval of a Novel Cell Line and Influenza Vaccine
  • Dan Adams - Executive Chairman and Global Head of Business Development, Protein Sciences Corporation, USA

Protein Sciences invented Flublok® influenza vaccine, the first approved recombinant flu vaccine, and its expresSF+® insect cell line and secured FDA approval in 2013. However, none of this was easy or straightforward.  This talk will focus on the difficulties encountered in overcoming the FDA’s concerns about a novel cell line, adventures in scale up in multiple countries, the problems developing companies encounter in marketing a novel flu vaccine and the prospects for such companies to succeed in this field.

11:20 - 11:50 30 mins
Systematic use of statistical DoE and in silico modeling to reduce experimentation during DSP development: A vaccine case study
  • Beckley Kungah Nfor - Scientist, Janssen Vaccines & Prevention B.V., The Netherlands

The production of safe and efficacious vaccines at low cost is essential to guarantee world-wide vaccine availability and affordability, especially in developing countries. Our proprietary PER.C6® cell line and PIN platform technologies have enabled the expression and production of viral vaccines at very high titers in cell cultures, thereby shifting the opportunities for further cost reduction to the downstream process (DSP). To reduce experimental workload needed for DSP development, a systematic approach involving the combined use of statistical DoE and in silico process modeling is proposed. This is exemplified by way of a case study involving the optimization of a chromatographic step for purification of a viral vaccine from PER.C6® derived cell culture harvest. The optimization problem involved four experimental factors (column load, flow rate, upper cut point, virus strain) and two outputs (virus purity and yield). The main objectives of the study were to define a design space satisfying all design constraints, and to define a higher operating column load (within the design space) so as to reduce column and buffer footprints (cost). Through the combined use of statistical DoE and in silico modeling, it was possible to achieve the set objectives with much fewer experiments than would have been needed with a purely DoE approach.

11:50 - 12:20 30 mins
A proven single-use platform to accelerate the development and production of viral vaccines
  • Amelie Boulais Raveneau - Vaccine Platform Marketing Manager, Integrated Solutions, Sartorius Stedim Biotech, France

Viral vectors have become one of the most rapidly evolving and promising fields in vaccinology and regenerative medicine. As the industry continues to grow, biomanufacturers are developing, optimizing and scaling-up production processes to establish or expand viral vector production facilities. We believe there is a significant opportunity for the industry to benefit from a platform-approach to produce viral vectors and live-viruses. In this presentation, we will discuss how a platform approach allow firms to reduce the time required to bring their products to the clinic and the market, and provide you with consistent process performance. We will describe the toolbox of technologies and services proven to be efficient in the development, production and analysis viral vectors processes. The performances of the viral vector platform will be illustrated in a case study based on adenoviruses.

12:20 - 13:35 75 mins
Lunch in the Exhibition Hall and Live Labs
13:35 - 14:05 30 mins
Feedback on the DiViNe Project – Vaccine purification by affinity chromatography
  • Manuel Carrondo - Professor of Chemical and Biochemical Engineering, FCT-UNL Vice-President,, iBET Portugal
14:05 - 14:35 30 mins
Spotlight presentation
14:35 - 15:05 30 mins
New approaches for characterization of genetic stability of vaccine cell lines
  • Ali Azizi - Senior Scientist, Analytical Research and Development, North America, Sanofi Pasteur, USA

Genetic mutations that occur during cell passaging in a bioreactor can lead to a heterogeneous population. These new mutations may impact product production and quality where small sub- populations could potentially overtake the initial cell culture, resulting in a final cell population that is different from the starting pool. For vaccine manufacturers, occurrence of mutations during cell culturing poses a risk to the use of recombinant proteins. The evaluation of gene copy numbers by a qPCR method is one of the common approaches used to assess the consistency of cell lines. However, due to several challenges including amplification efficiency differences that were apparent between these reference standards and test samples, two new approaches (Digital PCR and High throughput sequencing) were developed in our platform. The developed methods were able to overcome the challenges associated with the conventional methods such as qPCR. These technologies have been successfully used to characterize the genetic stability of cell lines including transgenic cell lines.

15:05 - 15:35 30 mins
Spotlight presentation
15:35 - 16:20 45 mins
Afternoon Coffee and Poster Tour Two (3 x Posters 30 Mins)
16:20 - 16:50 30 mins
Aluminium Based Suspensions Vs. Liposomal
  • Martinus Capelle - Scientific Director, Head Formulation Science & Technology, Janssen Pharmaceutical Companies of Johnson & Johnson, The Netherlands
16:50 - 17:50 60 mins
Efficacy Studies Of An Inactivation Process Of A Flaviviridae
  • Cédric Charretier - Head of Downstream Processing Unit, Bioprocess R&D Europe, Sanofi Pasteur, France
  • Vincent Marin - Scientific Manager, Downstream Processing, Bioprocess R&D Europe, Sanofi Pasteur, France
17:50 - 17:55 5 mins
End of BPI 2018