Achieving Operational Excellence in Biomanufacturing: Trends and Case Studies

1–2 December 2008
Barcelona, Spain

Seminar Leaders
Miriam Monge, Biopharm Services (France)
Dirk Böhm, Merck Serono (Switzerland)

Technical presentations, advice and experience from industry leaders, including updates on current regulatory requirements
Take-home case studies on key issues and hot topics
Insight into new technologies, concepts and ideas

The biopharmaceutical industry has grown rapidly over the last decade. This seminar will consider how to achieve operational effectiveness and will consider key issues such as the impact of disposable technology, flexible operation, fast turnaround and cost implications.

Practical techniques such as high titer cell culture, bio separation, DSP, continuous chromatography and aseptic fill and finish will be discussed alongside the strategic, operational and economic issues involved in their use. Including sessions on waste management and treatment, facilities, lean design, and the global hot topic – sustainability - the seminar speakers include technical experts and leaders in biomanufacturing innovations.

Using workshops, case studies and models to present concepts and discussions points, the speakers will take a global perspective on the issues involved in balancing more efficient and cost-effective processes, achieving higher returns on investment, improving science and technology and current regulatory requirements.

Take Back to Your Job

Stay current with the latest technologies and trends
Learn about new tools, approaches and best practice to support lean manufacturing
Update on current regulatory requirements in biomanufacturing
Benefit from peer learning in workshops and discussions

Agenda

Monday, 1 December

10.00 – 10.15 Welcome and Introduction
Miriam Monge, Biopharm Services (France)
Dirk Böhm, Merck Serono (Switzerland)

Biomanufacturing Challenges

10.15 – 10.55 The Facility of the Future
Johannes Roebers, Elan (Ireland)

The history and future of biotechnology manufacturing
Improvements in traditional manufacturing systems
Novel and single-use manufacturing systems
Comparison of systems and trends in manufacturing

10.55 – 11.35 Disposables Revolutionising Biomanufacturing?
Miriam Monge, Biopharm Services (France)

Implications of implementing the disposable project
Integrating design and procurement strategies
Reducing risk and managing the supply chain

Understanding Cost Tools and Approaches

11.35 – 12.15 Reducing Capital and Operating Costs in Biomanufacturing: The Role of Modelling Tools
Andrew Sinclair, Biopharm Services (UK)

Challenges of driving out costs
How do models provide insights to cost contributors within processes
Using cost models to set targets for lean manufacturing
Examining the use of cost modelling in practice

12.15 – 12.20 Questions and Answers

12.20 – 13.20 Lunch and Networking Break

Cell Culture Development

13.20 - 14.00 High Titer Cell Culture Using the Per C6 Cell Line
Robert Hof, DSM Biologics (Netherlands)

Extreme density cell culture; process design and benefits
High titer cell culture; holistic view on manufacturing
Disposable technologies
Potential manufacturing strategies

14.00 – 14.40 Operational, Economic and Strategic Analysis of the Single-use Bioreactor (SUB)
John Reid, Thermo Fisher Scientific (Country tbc)

Overview of SUB technology
Comparing stainless steel and SUB using advanced system analysis
Summary of SUB implementation case studies
Future technologies and strategies

14.40 – 15.20 State-of-the-art Media Development and Impact on Process Development and Manufacturing
Martin Jordan, Merck Serono (Switzerland)

Achieving operational excellence through establishing a generic platform to develop and optimise chemically defined media based on a scale down disposable culture technology
Balancing of key components to achieve an efficient medium
Ensuring a robust process by maintaining components within the desired range throughout the whole production phase

15.20 – 15.40 Coffee and Networking Break

More Effective Purification

15.40 – 16.20 Hot Topics in Bioseparation: Bottlenecks, Obstacles and Solutions
Uwe Gottschalk, Sartorius (Germany)

The role of biochromatography in downstream processing
Streamlining of operations
The role of emerging technologies
The use of disposables

16.20 – 17.00 Strategies to Achieve Operational Excellence in DSP
Manuel Nyffeler, GE Healthcare (Sweden)

Operational excellence framework in Biotech: LEAN and SixSigma
Relevance of LEAN in biomanufacturing
Recent process design options
Evaluation of benefits and risks
The need for alternative technology, both from a capability and a cost perspective
Elements of solutions aiming for operational excellence

17.00 – 17.15 Questions and Answers, Close of Day 1
Miriam Monge, Biopharm Services (France)
Dirk Böhm, Merck Serono (Switzerland)

17.30 – 18.30 Networking Reception

Tuesday, 2 December

08.30 – 08.45 Review of Day 1, Introduction to Day 2
Miriam Monge, Biopharm Services (France)
Dirk Böhm, Merck Serono (Switzerland)

More Effective Purification (continued)

08.45 – 09.25 MCSGP: Continuous Chromatography in Bioseparation
Guido Strölhein, ETH Zurich, Institute of Chemistry and Bioengineering (Switzerland)

Concept of continuous chromatography and the working principle of MCSGP
Comparison of a single column batch process and continuous MCSGP
Case study: Comparison of a cation-exchange MCSGP and batch Protein A affinity chromatography

Fill and Finish Considerations

09.25 – 10.05 Aseptic Fill and Finish Operations: Making the Right Technical and Commercial Decisions for Your Product
Jörg Zimmermann, Vetter Pharmaceuticals (Germany)

Make or buy decision for new production lines
Aseptic process designs: RABS and isolators
The use of disposables
Options for storage and transport for bulk product

10.05 – 10.35 Coffee and Networking Break

Effective Process Development

10.35 – 11.20 Effective Process Knowledge Management for Technology Transfer
Andrew Sinclair, Biopharm Services Ltd (UK)

Focussing on a joint research project, in collaboration with Avecia and MedImmune

Development of a process model with input from process development, technology transfer, and manufacturing staff to address the requirements of data transfer and communication which are critical success factors for technology.

Approach taken and lessons learned from the development effort to date, with specific case study study based on understanding the manufacturing implications in development

11.20 – 12.00 Leveraging Knowledge Management Techniques to Achieve Operation Excellence from Bioprocess Development to Biomanufacturing
Bruce Williams, Avecia (UK)

Practical challenges and issues faced in the typical operation environment

How should we look at process data and strategies for its management: lessons learnt from recent experience on the TSB project

Some implications from trials looking at rapid process siting in facilities

12.00 – 12.15 Questions and Answers
Miriam Monge, Biopharm Services (France)
Dirk Böhm, Merck Serono (Switzerland)

12.15 – 13.30 Lunch and Networking Break

13.30 – 14.15 Sustainability: Environmental and Waste Water Treatment Influences on New Process Development and Biomanufacturing
Dirk Böhm, Merck Serono (Switzerland)

Environmental impact and process development
Environmental impact and product lifecycle
Environmental impact and facility design

14.15 – 15.45 Workshops
Speakers of day 1 and day 2

More effective purification (increasing effectiveness)
Understanding cost tools and approaches
Sustainability and environmental impact
Implications of disposables technologies; where will this go?

15.45 – 16.30 Group Presentations and Close of Seminar
Miriam Monge, Biopharm Services (France)
Dirk Böhm, Merck Serono (Switzerland)


Conference Programme General Information Venue and Area Information Networking Evening Sponsorship Opportunities Table Top Exhibition Registration Information Download Brochure Current as of 18 August Delegates See the company and country background of already registered delegates !	Achieving Operational Excellence in Biomanufacturing: Trends and Case Studies 1–2 December 2008 Barcelona, Spain Seminar Leaders Miriam Monge, Biopharm Services (France) Dirk Böhm, Merck Serono (Switzerland) Technical presentations, advice and experience from industry leaders, including updates on current regulatory requirements Take-home case studies on key issues and hot topics Insight into new technologies, concepts and ideas The biopharmaceutical industry has grown rapidly over the last decade. This seminar will consider how to achieve operational effectiveness and will consider key issues such as the impact of disposable technology, flexible operation, fast turnaround and cost implications. Practical techniques such as high titer cell culture, bio separation, DSP, continuous chromatography and aseptic fill and finish will be discussed alongside the strategic, operational and economic issues involved in their use. Including sessions on waste management and treatment, facilities, lean design, and the global hot topic – sustainability - the seminar speakers include technical experts and leaders in biomanufacturing innovations. Using workshops, case studies and models to present concepts and discussions points, the speakers will take a global perspective on the issues involved in balancing more efficient and cost-effective processes, achieving higher returns on investment, improving science and technology and current regulatory requirements. Take Back to Your Job Stay current with the latest technologies and trends Learn about new tools, approaches and best practice to support lean manufacturing Update on current regulatory requirements in biomanufacturing Benefit from peer learning in workshops and discussions Agenda Monday, 1 December 10.00 – 10.15 Welcome and Introduction Miriam Monge, Biopharm Services (France) Dirk Böhm, Merck Serono (Switzerland) Biomanufacturing Challenges 10.15 – 10.55 The Facility of the Future Johannes Roebers, Elan (Ireland) The history and future of biotechnology manufacturing Improvements in traditional manufacturing systems Novel and single-use manufacturing systems Comparison of systems and trends in manufacturing 10.55 – 11.35 Disposables Revolutionising Biomanufacturing? Miriam Monge, Biopharm Services (France) Implications of implementing the disposable project Integrating design and procurement strategies Reducing risk and managing the supply chain *Understanding Cost Tools and Approaches* 11.35 – 12.15 Reducing Capital and Operating Costs in Biomanufacturing: The Role of Modelling Tools Andrew Sinclair, Biopharm Services (UK) Challenges of driving out costs How do models provide insights to cost contributors within processes Using cost models to set targets for lean manufacturing Examining the use of cost modelling in practice 12.15 – 12.20 Questions and Answers 12.20 – 13.20 Lunch and Networking Break Cell Culture Development 13.20 - 14.00 High Titer Cell Culture Using the Per C6 Cell Line Robert Hof, DSM Biologics (Netherlands) Extreme density cell culture; process design and benefits High titer cell culture; holistic view on manufacturing Disposable technologies Potential manufacturing strategies 14.00 – 14.40 Operational, Economic and Strategic Analysis of the Single-use Bioreactor (SUB) John Reid, Thermo Fisher Scientific (Country tbc) Overview of SUB technology Comparing stainless steel and SUB using advanced system analysis Summary of SUB implementation case studies Future technologies and strategies 14.40 – 15.20 State-of-the-art Media Development and Impact on Process Development and Manufacturing Martin Jordan, Merck Serono (Switzerland) Achieving operational excellence through establishing a generic platform to develop and optimise chemically defined media based on a scale down disposable culture technology Balancing of key components to achieve an efficient medium Ensuring a robust process by maintaining components within the desired range throughout the whole production phase 15.20 – 15.40 Coffee and Networking Break More Effective Purification 15.40 – 16.20 Hot Topics in Bioseparation: Bottlenecks, Obstacles and Solutions Uwe Gottschalk, Sartorius (Germany) The role of biochromatography in downstream processing Streamlining of operations The role of emerging technologies The use of disposables 16.20 – 17.00 Strategies to Achieve Operational Excellence in DSP Manuel Nyffeler, GE Healthcare (Sweden) Operational excellence framework in Biotech: LEAN and SixSigma Relevance of LEAN in biomanufacturing Recent process design options Evaluation of benefits and risks The need for alternative technology, both from a capability and a cost perspective Elements of solutions aiming for operational excellence 17.00 – 17.15 Questions and Answers, Close of Day 1 Miriam Monge, Biopharm Services (France) Dirk Böhm, Merck Serono (Switzerland) 17.30 – 18.30 Networking Reception Tuesday, 2 December 08.30 – 08.45 Review of Day 1, Introduction to Day 2 Miriam Monge, Biopharm Services (France) Dirk Böhm, Merck Serono (Switzerland) More Effective Purification (continued) 08.45 – 09.25 MCSGP: Continuous Chromatography in Bioseparation Guido Strölhein, ETH Zurich, Institute of Chemistry and Bioengineering (Switzerland) Concept of continuous chromatography and the working principle of MCSGP Comparison of a single column batch process and continuous MCSGP Case study: Comparison of a cation-exchange MCSGP and batch Protein A affinity chromatography Fill and Finish Considerations 09.25 – 10.05 Aseptic Fill and Finish Operations: Making the Right Technical and Commercial Decisions for Your Product Jörg Zimmermann, Vetter Pharmaceuticals (Germany) Make or buy decision for new production lines Aseptic process designs: RABS and isolators The use of disposables Options for storage and transport for bulk product 10.05 – 10.35 Coffee and Networking Break Effective Process Development 10.35 – 11.20 Effective Process Knowledge Management for Technology Transfer Andrew Sinclair, Biopharm Services Ltd (UK) Focussing on a joint research project, in collaboration with Avecia and MedImmune Development of a process model with input from process development, technology transfer, and manufacturing staff to address the requirements of data transfer and communication which are critical success factors for technology. Approach taken and lessons learned from the development effort to date, with specific case study study based on understanding the manufacturing implications in development 11.20 – 12.00 Leveraging Knowledge Management Techniques to Achieve Operation Excellence from Bioprocess Development to Biomanufacturing Bruce Williams, Avecia (UK) Practical challenges and issues faced in the typical operation environment How should we look at process data and strategies for its management: lessons learnt from recent experience on the TSB project Some implications from trials looking at rapid process siting in facilities 12.00 – 12.15 Questions and Answers Miriam Monge, Biopharm Services (France) Dirk Böhm, Merck Serono (Switzerland) 12.15 – 13.30 Lunch and Networking Break 13.30 – 14.15 Sustainability: Environmental and Waste Water Treatment Influences on New Process Development and Biomanufacturing Dirk Böhm, Merck Serono (Switzerland) Environmental impact and process development Environmental impact and product lifecycle Environmental impact and facility design 14.15 – 15.45 Workshops Speakers of day 1 and day 2 More effective purification (increasing effectiveness) Understanding cost tools and approaches Sustainability and environmental impact Implications of disposables technologies; where will this go? 15.45 – 16.30 Group Presentations and Close of Seminar Miriam Monge, Biopharm Services (France) Dirk Böhm, Merck Serono (Switzerland)

Achieving Operational Excellence in Biomanufacturing: Trends and Case Studies

1–2 December 2008 Barcelona, Spain

Agenda

1–2 December 2008
Barcelona, Spain