Wednesday, 27 June 2012

08:00

Registration


Adoption of Single-Use Technologies; Trends, Risks and Benefits

09:30

Claus TollnickKeynote Presentation

CANCELLED - Single-Use Technologies - the Key to Lean & Fast Development & GMP Batch Manufacturing?
Claus Tollnick, Head R&D, Sanofi Aventis, Germany

In this talk, I will share our experience in the sanofi group (including Genzyme and Sanofi-Pasteur) with applications of single-use technologies, our considerations prior to engaging, good and bad surprises and where we stand today.

10:00

Accelerating Lean Processing Through Disposable Technology and Systems
Nigel Smart, VP & Managing Partner , Smart Consulting Group, United States of America

This presentation will provide you with insight into how to; • Improve process flexibility • Reduce production lead time • Achieve shorter turn around times • Successfully integrate upstream and downstream processes • Improve supplier reliability through Lean approaches to supplier mangement

10:30

Coffee Break & Networking in Exhibition Hall

11:15

The ABC of Single-use Systems: Applications, Benefits and Challenges
Bruce Rawlings, Product Manager, Pall Life Sciences, United Kingdom

This presentation will provide an overview of the applications for single-use technologies and systems in a variety of processes, looking at the benefits and challenges associated with implementation.

11:45

Stephen BrownKeynote Presentation

The Challenges of Adopting Single Use Technology
Stephen Brown, Chief Technical Officer, Vivalis, France

During my presentation, I will review our experience for the implementation of Single Use Systems (SUS) for pharmaceutical development operations within Vivalis. These innovative systems bring many advantages to biopharmaceutical manufacturing and a carefully managed selection and implementation process can accelerate timelines and help avoid hidden technical and quality pitfalls. These points will be illustrated by case histories.

12:15

Lunch & Networking in Exhibition Hall

13:30

Poster Viewing Session


Comparability of Single Use Technologies

14:15

SUT Applications in Up – and Downstream Bioprocessing
Manuel Carrondo, Professor, Universidade Nova de Lisboa, Portugal

Comparative studies of different SU Bioreactors against traditional vessels carried out at pilot scale will be presented for the production of viruses for vaccines and gene therapy. For the same applications novel designs, based on scale down tools, for disposable membranes for purification will be described.

14:45

Implementation of Single Use Technology for Production of the UK Anthrax Vaccine
Kelly Lowings, Senior Scientist, Vaccine Research Group, Health Protection Agency, United Kingdom

We have assessed the possibility of modernising fermentation of the UK Anthrax Vaccine utilising Single Use Technology and have shown that a similar range of proteins and known vaccine antigens are produced using modernised compared to traditional methods.

15:15

Coffee Break & Networking in Exhibition Hall


Economic & Market Trends

16:00

Market Trends in Adoption of Single-use Devices in BioManufacturing
Eric Langer, Managing Partner & President, Bioplan Associates Inc, United States of America

9th Annual Report of BioManufacturing indicates budgets for SUS increased by 6%, usage by 17%; lingering problems continue to restrict adoption

16:30

Impact of Single-Use Technologies upon Bioprocess Economics. The Current and Future Opportunities and Challenges
Andrew Brown, Senior Consultant Engineer, Biopharm Services Ltd, United Kingdom

Single-use technologies have long been utilised within bioprocesses from the early days of single use bags to the current state of the art single-use bioreactors. This presentation will consider the economic advantages offered by single-use technology. Future opportunities to reduce cost further will also be highlighted.

17:00

Drinks Reception

Thursday, 28 June 2012


Single Use Technologies in Up and Downstream Processing

09:30

Strategy for True Single Use All the Way from Process Development to GMP Production
Tony Hitchcock, Head, Cobra Biomanufacturing Plc, United Kingdom

This talk is focused on how the single use system can be used to simplify and accelerate development programmes from cell line development through to the production of materials for first in man studies.

10:00

BioSMB™: A Fully Disposable Continuous Chromatography for the Purification of Biopharmaceuticals
Marc Bisschops, Scientific Director, Tarpon Biosystems, United States of America

In this presentation, we will present experimental data to illustrate the impact of BioSMB™ Technology for the purification of monoclonal antibodies and vaccine products.

10:30

Coffee Break & Networking in Exhibition Hall

11:15

Development of a Fast Influenza Virus-Like-Particle Vaccine Production Process Based on Single-Use Technology
Regine Eibl, Professor, University of Applied Sciences, Switzerland

The successful process development for a multiprotein-influenza VLP-candidate using a Spodoptera frugiperda (Sf-9) cell line will be presented. The focus is on the fully disposable upstream processing (establishment of large-scale working cell bank in cryobags, one-step cell expansion, generation of baculovirus production stock, and preclinical VLP sample productions in up to 20L wave-mixed bags). The complete single-use production process delivered active VLPs reaching concentrations of up to 3 mg L-1.

11:45

Engineering Aspects of MAb Production in Single-Use Bioreactors
Henry Lamb, Professor, North Carolina State University, United States of America

Basic understanding of mixing and mass transfer in single-use bioreactors informs tech transfer and scale-up to produce mAbs in high yield with quality comparable to product from conventional stainless steel bioreactors.

12:15

Lunch & Networking in Exhibition Hall

13:30

Poster Viewing Session

14:15

Single-use Bioreactors: Fundamental Studies on the Impact of Engineering Parameters on Cell Culture Performance
Martina Micheletti, Lecturer, University College London, United Kingdom

The talk presents mixing studies conducted in different single-use bioreactors aiming at the characterization of the hydrodynamic environment in order to improve understanding of its effect on cell performance and appropriately select scale-up methodologies.

14:45

A Novel Approach to Early Process Design of Therapeutic Monoclonal Antibody Production in CHO Cells Using an Optically-Based Single-Use Mini-Bioreactor Technology
Jean-Francois Hamel, Sponsored Research, Massachusetts Institute of Technology, United States of America

This study proposes an innovative early optimization process for biosimilar monoclonal antibodies (mAb) that combines optically-based mini-bioreactor and lectin array-based glycoanalytical technologies to optimize (mAb) titer and glycosylation, in parallel.   

15:15

Coffee Break & Networking in Exhibition Hall

15:45

High Level Protein Production by CHOBC® Cells in CELLtainer Disposable Bioreactors
Bram Bout, CEO, Bioceros BV, Netherlands

Selection of high monoclonal antibody producing CHO cell lines and performance of a number of these cell lines in fed batch cultures in the single use CELL-tainer bioreactor. Process data and yields (up to 3,8 g/L) will be presented.

16:15

Plasma Treatment at Atmospheric Pressure – a Versatile Tool to Modify Substrates with Complex Geometries
Kristina Lachmann, Scientist, Fraunhofer Institute for Surface Engineering and Thin Films, Germany

The presentation should give a brief overview on the possibilities of atmospheric pressure plasma processes for biomedical applications. This technique is a suitable tool to modify temperature-sensitive substrates in under gentle conditions.

16:45

Close of Conference