Day One – Monday 28 February 2011

Day One – Monday 28 February 2011 »

Day Two – Tuesday 1 March 2011 »

Day Three – Wednesday 2 March 2011 »

last modified: 24 February '11

08.00

Registration and refreshments

09.00

Chairman’s opening remarks

› Dr Hansjoerg Hauser,

Head of Department: Molecular Biotechnology and Head of Division: Gene Regulation and Differentiation, Helmholtz Centre for Infection Research, Germany

CELL CULTURE IN THE AGE OF BIOLOGICS

09.10

Biologic and biopharma industry demand for improved cell culture systems

How is the increasing prevalence of biologic therapeutics fuelling the cell culture industry? Where are the greatest areas of growth and demand?
How are Big Pharma and biotech using cell culture procedures to improve biologic production?
In-house development of cell culture techniques and technologies vs external licensing.

› Herve Broly,

Vice President Biotech Process Development, Merck Serono, Switzerland

09.40

Understanding the cell culture market and its impact on the biologic industry

What is the scope of available technology for improving cell culture-based biomanufacturing?
Utilising this market to improve biologic development: considering engineering of cells and vectors, media, optimisation, scale-up and improving cell culture facilities.
Optimal use of cell culture technology to improve biologic production.

› Dr Alain Pralong,

Vice President, Process Development, Crucell, The Netherlands

10.10

Critical challenges for cell culture-based bioproduction

What are the critical challenges to be considered using cellculture systems for bioproduction?
How can these be overcome using innovative procedures and
new technologies?
Where do future developments need to be made to improve
cell culture-based bioproduction?

› Isabelle Piérard,

Director, Industrialization - Primary Manufacturability, GSK Biologicals, Belgium

10.40

Speed Networking

11.30

Morning refreshments

11.50

Alternate application for cell culture: offsetting cost and quality for vaccines in animal health

Understanding challenges for viral production.
Using cell culture-based bioproduction application to overcome viral production challenges.
Future outlook and impact of cell culture development on the animal health sector.

› Johannes deRee,

Head of Animal Health Pilot Plant, Pfizer Animal Health, Belgium

12.20

Panel discussion: optimising biomanufacturing by leveraging cell culture

How are the World’s leading biologic companies using cell culture procedures to improve manufacturing capabilities?
What are the crucial challenges in biotherapeutic development which can be solved by cell culture?
How are development trends in both the biologic and cell culture industries interacting to improve overall process?

› Dr Hansjoerg Hauser,
(Moderator)

Head of Department: Molecular Biotechnology and Head of Division: Gene Regulation and Differentiation, Helmholtz Centre for Infection Research, Germany

› Herve Broly,

Vice President Biotech Process Development, Merck Serono, Switzerland

› Dr Alain Pralong,

Vice President, Process Development, Crucell, The Netherlands

› Johannes deRee,

Head of Animal Health Pilot Plant, Pfizer Animal Health, Belgium

› Isabelle Piérard,

Director, Industrialization - Primary Manufacturability, GSK Biologicals, Belgium

13.00

Networking lunch sponsored by Xcellerex

CELL LINE ENGINEERING AND SELECTION

14.00

Improving process efficiency by rational design

Using recombinant-mediated rational design to streamline cell line engineering.
Making the process more efficient: what are the steps to putting rational design into practice?
Current applications: how has rational design been applied to cell line engineering for biomanufacture applications thus far? What is the future?

› Dr Hansjoerg Hauser,

Head of Department: Molecular Biotechnology and Head of Division: Gene Regulation and Differentiation, Helmholtz Centre for Infection Research, Germany

14.30

Cell line selection strategies for protein manufacture

Challenges for the early development of cell lines for protein manufacture: considering yield, stability and speed.
Putting best-practice methods into action upstream to optimise downstream productivity: strategies and key considerations for modifying the process.
Leveraging internal and vendor capabilities to make better use of existing technologies.

› Michael Bowen,

Head of cell line engineering, Medimmune, United States

15.00

New technologies as a tool for cell line development

Generation and production of cell lines for bioproduction:challenges and solutions for clone screening and cell line development.
Evaluation of new technologies to overcome these
challenges and improve the process.

› Dr Zorica Dragic,

Lab Head, Integrated Biologics, Novartis Biotechnology, Switzerland

15.30

Afternoon refreshments

16.00

From DNA to commercial process: optimising process development to generate antibodies for therapeutic use

Engineering platform technologies to express proteins in hightitres.
Implementing disposable technology in commercial process
development.
Balancing front- vs back-loading in process development for Phase 1 and beyond.

› Dr Stefan Schlatter,

Associate Director Upstream Development, Boehringer Ingelheim GmbH, Germany

16.30

Development and optimal use of cell culture technologies for discovery and production of human antibodies

Integrating high throughput antibody isolation to constructionof production cell lines.
Elimination of requirements for clone-based cell line selection and process optimisation.
Enabling the isolation of highest-secreting cells by flow cytometry.

› Gang Chen,

Senior Director, Cell Technologies, Regeneron Pharmaceuticals, United States

17.00

CAP-Technology: production of biopharmaceuticals in human amniocytes

Obtaining high production yields of recombinant proteins using CAP-Technology.
Understanding advantages of the CAP technology: allowing for high yield production of recombinant proteins, with excellent biologic activity and therapeutic activity as a result of post-translational modification.
Development of the CAP technology as a unique platform from very early pre-clinical evaluation up to clinical supply: CAP-T cells, a transient expression system that enables extremely high production yields of recombinant proteins within a few days and CAP cells for very high yield stable expression of biotherapeutics.

› Dr Hartmut Tintrup,

Director of Marketing and Business Development, Cevec Pharmaceuticals GmbH, Germany

17.30

Panel discussion: evaluating optimal technologies and techniques for cell line engineering

Given the current applications of cell culture within theindustry what emergent technologies and process techniques are required to optimise cell line engineering?
New developments: improving how cells grow in culture; using platform technologies to improve host capabilities; developing cell line stability and maintaining secretion levels.
Evaluating mammalian cells as hosts for the production of recombinant proteins, vaccines and cell therapy.

› Dr Hansjoerg Hauser,
(Moderator)

Head of Department: Molecular Biotechnology and Head of Division: Gene Regulation and Differentiation, Helmholtz Centre for Infection Research, Germany

› Michael Bowen,

Head of cell line engineering, Medimmune, United States

› Dr Stefan Schlatter,

Associate Director Upstream Development, Boehringer Ingelheim GmbH, Germany

› Gang Chen,

Senior Director, Cell Technologies, Regeneron Pharmaceuticals, United States

18.10