2017 speakers include - oxford global marketing – 7th ... · pdf filebayer pharma ag...

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Day 1 Stream 1 Cell Line Development: Early Cell Culture & Cell Line Engineering Exploring regulatory pathways for biologics CHO and stem cells and protein expression strategies for cell line engineering Emerging cell culture technologies and applications 3D Cell Culture Clone selection strategies & establishing clonality Vaccine development Applications of single cell technology in cell culture MicroRNAs for cell line development Day 1 Stream 2 Process Development Novel downstream purification approaches Upstream process spectroscopy Process scale-up including 3D technologies Fed batch vs. novel continuous manufacturing tools and techniques Integrated continuous processing methods High throughput technologies in bioprocessing Single use technologies o Bioreactors Meet Senior Decision Makers 250 VPs, Directors & Senior Managers from leading pharmaceutical organisations, biotech companies and academic institutions will attend the event. Delegate job titles include: Discover New Solutions Formal and informal meeting opportunities offer delegates the chance to discuss key solutions with leading service providers. Services to be discussed include: Day 2 Stream 1 Cell Line Development: Late Stage Cell Line Development, Stability, Data & Assay Data Development Improving stability of cell mammalian & bacterial cell lines Ensuring high yield cell lines: tools & technologies Genetic cell line characterisation Targeted sequencing for recombinant CHO cell lines Expression screening, and production cell line development Mammalian expression systems Strategies of novel bispecific antibodies High throughput analytics Applications of ‘omics technologies in cell line development Benefits to Attending Hear from and meet with key cell culture and bioprocessing innovators. 2017 attendees include: Associate Director, Merck; Head of Launch Preparation and Coordination, Bayer Pharma AG and Director Global Regulatory Affairs, Biogen Discuss collaborative solutions to early and late stage cell line development, cell line engineering and stability, data & assay data development. This year’s congress will bring key figures together to address the latest in cell line engineering, CHO host cell line engineering, vaccine development, cell line characterisation and single cell technology Discover the hottest technologies and newest techniques that are advancing in process development, biological production and bioprocessing, including novel downstream purification , and high throughput processing efficient upstream and downstream processing, and manufacture and logistics of next generation therapeutics Take advantage of our unparalleled networking opportunities. Hear about opportuntiies for partnerhsips and collaborations, and experience the very best in interactive business and scientific exchange through regular networking breaks, pre-organised 1-2-1 meetings our popular evening drinks reception and more Experience our unbeatable programme of talks devised with the help of our esteemed advisory board. Featuring leading senior academics and high profile industry speakers from the most innovative pharmaceutical companies covering everything from early cell line selection to high yield commercial manufacture Co-located with our 4 th Annual Stem Cell Congress and 3 rd Annual Cell & Gene Therapy Congress covering cell therapy, gene therapy & stem cell bioprocessing presentations Cell Line Engineering Cell Culture Biologics Manufacturing Upstream Processing Genome Editing Stem Cell Culture Process Engineering Technology Transfer Drug Discovery Bioprocessing Downstream Processing Quality Control Bioreactors Perfusion Technologies Cell Culture Analysing 4D Tissue Engineering Transfection Technology Process Analytics Media Quality Control Engineer Purification Clone Stability Cell Line Authentication 3D Cell Culture High Throughput Technologies For booking details & registration fees please refer to the last page or visit: http://www.cellculture-congress.com/marketing 2017 Speakers Include… Ulrich Ruenapp Elizabeth Harker- Patrick Hossler Bayer Pharma AG Scheideman, NIH Abbvie Day 2 Stream 2 Biological Production & Bioprocessing Key hurdles in the manufacture of biologics Manufacture and logistics of next generation therapeutics Continuous chromatography: bioprocessing case studies Manage complex technology transfers Improving yield for commercial production Novel large scale production tools & technologies o Microscale cultures Overcoming PAT & QbD challenges Do not miss out on our exclusive complimentary webinars: CHO Host Cell Engineering and Expression Vector Development, 5th September 2017 Register for free. Regulatory Strategies to Implement your Manufacturing Processes,12 th September 2017 Register for free.

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Page 1: 2017 Speakers Include - Oxford Global Marketing – 7th ... · PDF fileBayer Pharma AG Scheideman, ... Purification Platform Lead TS/MS Eli Lilly • Steffen Sass, Data Scientist,

Day 1 Stream 1 – Cell Line Development: Early Cell Culture & Cell Line Engineering

• Exploring regulatory pathways for biologics

• CHO and stem cells and protein expression strategies for cell line engineering

• Emerging cell culture technologies and applications

• 3D Cell Culture

• Clone selection strategies & establishing clonality

• Vaccine development

• Applications of single cell technology in cell culture

• MicroRNAs for cell line development

Day 1 Stream 2 – Process Development

• Novel downstream purification approaches

• Upstream process spectroscopy

• Process scale-up including 3D technologies

• Fed batch vs. novel continuous manufacturing tools and techniques

• Integrated continuous processing methods

• High throughput technologies in bioprocessing

• Single use technologies o Bioreactors

Meet Senior Decision Makers 250 VPs, Directors & Senior Managers from leading pharmaceutical organisations, biotech companies and academic institutions will attend the event. Delegate job titles include:

Discover New Solutions Formal and informal meeting opportunities offer delegates the chance to discuss key solutions with leading service providers. Services to be discussed include:

Day 2 Stream 1 – Cell Line Development: Late Stage Cell Line Development, Stability, Data & Assay Data Development

• Improving stability of cell mammalian & bacterial cell lines

• Ensuring high yield cell lines: tools & technologies

• Genetic cell line characterisation

• Targeted sequencing for recombinant CHO cell lines

• Expression screening, and production cell line development

• Mammalian expression systems

• Strategies of novel bispecific antibodies

• High throughput analytics

• Applications of ‘omics technologies in cell line development

Benefits to Attending

✓ Hear from and meet with key cell culture and bioprocessing innovators. 2017 attendees include: Associate Director, Merck;

Head of Launch Preparation and Coordination, Bayer Pharma AG and Director Global Regulatory Affairs, Biogen

✓ Discuss collaborative solutions to early and late stage cell line development, cell line engineering and stability, data & assay

data development. This year’s congress will bring key figures together to address the latest in cell line engineering, CHO host cell

line engineering, vaccine development, cell line characterisation and single cell technology

✓ Discover the hottest technologies and newest techniques that are advancing in process development, biological production and bioprocessing, including novel downstream purification , and high

throughput processing efficient upstream and downstream processing, and manufacture and logistics of next generation therapeutics

✓ Take advantage of our unparalleled networking opportunities. Hear about opportuntiies for partnerhsips and collaborations, and experience

the very best in interactive business and scientific exchange through regular networking breaks, pre-organised 1-2-1 meetings our popular

evening drinks reception and more

✓ Experience our unbeatable programme of talks devised with the help of our esteemed advisory board. Featuring leading senior

academics and high profile industry speakers from the most innovative pharmaceutical companies covering everything from early cell line

selection to high yield commercial manufacture

✓ Co-located with our 4th Annual Stem Cell Congress and 3rd Annual Cell & Gene Therapy Congress covering cell therapy, gene therapy &

stem cell bioprocessing presentations

Cell Line Engineering Cell Culture Biologics Manufacturing

Upstream Processing Genome Editing Stem Cell Culture

Process Engineering Technology Transfer Drug Discovery

Bioprocessing Downstream Processing Quality Control

Bioreactors Perfusion Technologies Cell Culture Analysing

4D Tissue Engineering Transfection Technology Process Analytics

Media Quality Control Engineer Purification Clone Stability

Cell Line Authentication 3D Cell Culture High Throughput Technologies

For booking details & registration fees please refer to the last page or visit:

http://www.cellculture-congress.com/marketing

2017 Speakers Include…

Ulrich Ruenapp Elizabeth Harker- Patrick Hossler Bayer Pharma AG Scheideman, NIH Abbvie

Day 2 Stream 2 – Biological Production & Bioprocessing

• Key hurdles in the manufacture of biologics

• Manufacture and logistics of next generation therapeutics

• Continuous chromatography: bioprocessing case studies

• Manage complex technology transfers

• Improving yield for commercial production

• Novel large scale production tools & technologies o Microscale cultures

• Overcoming PAT & QbD challenges

Do not miss out on our exclusive complimentary webinars:

• CHO Host Cell Engineering and Expression Vector Development,

5th September 2017 – Register for free.

• Regulatory Strategies to Implement your Manufacturing

Processes,12th September 2017 – Register for free.

Page 2: 2017 Speakers Include - Oxford Global Marketing – 7th ... · PDF fileBayer Pharma AG Scheideman, ... Purification Platform Lead TS/MS Eli Lilly • Steffen Sass, Data Scientist,

For more information please contact [email protected]

2017 Confirmed Speakers Include:

• Diane Wilkinson, Director Global Regulatory Affairs CMC, Biogen

• Matthieu Stettler, Associate Director, Merck Biopharma

• Eric Wallenstein, Associate Director, Global Technical Operations-External Biologics Manufacturing, Merck & Co., Inc.

• Markus Michael Müller, Associate Director Cell Culture Development, Boehringer Ingelheim

• Ulrich Ruemenapp, Head of Launch Preparation and Coordination, Bayer Pharma AG

• Oliver Chao, Head, Emerging Biomedical Sciences, Responsable Partenariats, Sanofi

• Stefan Seeber, Principal Scientist, Dept. Cell Line and Molecule Development, Roche

• Jose Gomes, Manager and Principal Scientist, Pfizer

• Vishal Rosha, Fellow, BTDM – Advance Process and Manufacturing Technologies, Novartis

• Patrick Hossler, Principal Research Scientist, Process Sciences, Abbvie

• Xiaotian Zhong, Senior Principal Scientist/Lab Head, Pfizer

• Anne-Marie Beauchard, Principal Scientist, Sanofi

• Sune Klint Andersen,Principal Scientist, Drying Processes and Particle Technology in CMC, Novo Nordisk A/S

• Christopher Sampson, Investigator, Cell Line Development, Cell & Gene Therapy, GlaxoSmithKline

• Kristi Daris, Senior Scientist, Amgen

• Anke Mayer-Bartschmid, Senior Scientist Cell Line Development, Bayer

• Gisela Ferreira, Senior Scientist, Late Stage Process Development, Medimmune

• David Bruehlmann, Associate Manager, Merck Biopharma

• Xavier Derouck, Senior Sourcing Group Manager of Bioprocessing, GlaxoSmithKline

• Stanislas Augusto, Product/Process Specialist for OPV and Verorab Vaccines, Sanofi Pasteur

• Graham McCartney, Purification Platform Lead TS/MS Eli Lilly

• Steffen Sass, Data Scientist, Roche

• Clare Lovelady, Scientist I, Medimmune

• Shaymaa El Taieb, Cell Culture Specialist and Scientist, MSAT BioMarin

• Dave Knop, Director, Process Development, Applied Genetic Technologies Corporation

• Carol Knevelman, Head of Process R&D and Principal Scientist, Oxford Biomedica

• Bastiaan Leewis, MSAT Manager – Industrialisation, Meiragtx

• Helen Maunder, Senior Scientist, Oxford Biomedica

• Valentina Ciccarone, Principal Scientist, Macrogenics, Inc.

• Rhian Carter, Team Leader, Process R&D Scientist, Oxford Biomedica

• Elizabeth Harker Scheideman, Director Cell Line Developement, Vaccine Production Program, VRC/NIAID/NIH

• Sakis Mantalaris, Head of Biological Systems Engineering Laboratory Group and Professor, Imperial College London

• Stefan Przyborski, Professor of cell technology, Durham University

• John Masters, Professor of Experimental Pathology, University College London

• Mikael Rørdam Andersen, Associate Professor, Technical University of Denmark

• Parmjit Jat, Professor of Neurodegenerative Disease, University College London

• Gilles Joucla, Assocaite Professor, National School of Biomolecular Technologies of Bordeaux

• Robert Thomas, Reader and EPSRC Early Career Fellow,Wolfson School of Mechanical and Manufacturing Engineering, Loughborough University

Confirmed Cell & Gene Therapy Speakers Include:

• Rahul Aras, President, Co-founder & CEO, Juventas Therapeutics

• David Sourdive, Co-founder, Executive Vice President, Cellectis

• Sven Kili, Vice President and Head of Gene Therapy Development, GlaxoSmithKline

• Cedrik Britten, Vice President & Head of Oncology Cell Therapy DPU, GlaxoSmithKline

• Markwin Velders, Vice President, Operations, Kite Pharma

• Gwendolyn Binder-Scholl, Chief Technology Officer, Adaptimmune

• Ajan Reginald, Executive Director & Co-founder, Cell Therapy Ltd

• Sylvain Arnould, Process Development & Production Director, Celyad

• Alex Bloom, Director, Global Regulatory Affairs, CellMedica

• Michael Mercaldi, Director, Purification Process Development and Manufacturing, Codiak Biosciences

• Joachim Scholpp, Global Head of Clinical Pharmacology Program Leadership, Boehringer Ingelheim

• Katherine Tsokas, Regulatory Head of Regenerative Medicine & Advanced Therapy, Janssen Research & Development

• Tanvir Tabish, Head of Drug Product Development for Gene Therapy and Coagulation Factors, Shire

• Nitza Thomasson, Chief Preclinical Officer, Gensight Biologics

• Jacqueline Barry, Chief Clinical Officer, Cell Therapy Catapult

Page 3: 2017 Speakers Include - Oxford Global Marketing – 7th ... · PDF fileBayer Pharma AG Scheideman, ... Purification Platform Lead TS/MS Eli Lilly • Steffen Sass, Data Scientist,

For more information please contact [email protected]

If you’re on Twitter, make sure to follow us @cellcultureconf and join the congress conversation on #CCULT17

• Emily Culme-Seymour, External Strategy Manager, Gene Therapy, Rare Diseases Unit, R&D, GlaxoSmithKline

• Juliana Woda, Project Manager, BioMotiv

• Verena Vanessa Fischer, Lab Head in Early Stage Bioprocess Development, Boehringer Ingelheim

• Monicah Otieno, Director of Mechanistic & Investigative Toxicology, Janssen

• David Schaffer, Director, Berkeley Stem Cell Center, University of California, Berkeley

Confirmed Stem Cell Speakers Include:

• Che Connon, Professor of Tissue Engineering, Newcastle University

• Timothy O’Brien, Director, Regenerative Medicine Institute, National University of Ireland Galway

• David Schaffer, Director, Berkeley Stem Cell Center, University of California, Berkeley

• David Hay, Principal Investigator, MRC Centre for Regenerative Medicine, University of Edinburgh

• Francesco Saverio Tedesco, Principal Research Associate, Cell & Developmental Biology, Div of Biosciences, University College London

2017 Cell Culture & Bioprocessing, Cell & Gene Therapy and Stem Cell Congress Sponsors Include:

Page 4: 2017 Speakers Include - Oxford Global Marketing – 7th ... · PDF fileBayer Pharma AG Scheideman, ... Purification Platform Lead TS/MS Eli Lilly • Steffen Sass, Data Scientist,

For more information please contact [email protected]

6th Annual Cell Culture & Bioprocessing Congress Day One – 6th November 2017

07.30 – 08.20 Registration

08.20 – 08.25 Oxford Global’s Welcome Address

08.25 – 08.30 Chairman’s Opening Address

08.30 – 09.00 Co-located Keynote Address: Exploring Regulatory Pathways For Biologics

Diane Wilkinson, Director Global Regulatory Affairs CMC, Biogen

Cell Line Development Process Development

09.00 – 09.30 Stream Keynote Address: Optimizing CHO Cell Culture Process Through Mechanistic Understanding Of Cysteine Capping Modifications For Improving Site-specific ADCs • Antibody-drug conjugates (ADCs) consist of an

antibody armed with potent cytotoxic drugs, offering prospect of selective delivery of toxic payloads to tumors. Cysteine (Cys)-based site-specific ADCs allow for a rapid and simple chemical conjugation reaction to attach diverse linkers/ payloads to provide homogeneous ADC products

• This presentation will describe a novel discovery on Cys residue’s post-translational modification in stable CHO cells. The so-called Cys-capping modification utilizes a mechanism that is different from the conventional oxidoreductase-mediated process for protein disulfide formation

• The unexpected discovery has led to a novel and highly efficient CHO cell culture process for improving protein therapeutics conjugation

Xiaotian Zhong, Senior Principal Scientist/Lab Head, Pfizer

Stream Keynote Address: Novel Downstream Purification Approaches

Matthieu Stettler, Associate Director, Merck Biopharma

09.30 – 10.00 Solution Provider Presentation

Solution Provider Presentation

For sponsorship opportunities please contact

[email protected]

10.00 – 11.20 Morning Coffee & Refreshments, One to One Meetings x3, Poster Presentation Sessions

11.20 – 11.50 Emerging Cell Culture Technology

Oliver Chao, Head, Emerging Biomedical Sciences, Responsable Partenariats, Sanofi

Scale Up Approaches For Cell Culture

Jose Gomez, Manager and Principal Scientist, Pfizer

11.50 – 12.20 Expansion Of the N-Glycan Code In Mammalian

Expressed Glycoproteins

A novel approach was developed to reduce high-mannose

N-glycan species, eliminate fucose, and display atypical

sugars in various recombinant human immunoglobulin

preparations. These glycoengineered therapeutic proteins

provided for strategic benefits, including a reduction in

antigen presenting cell uptake, increased FcRIIIa

signaling, and a significantly increased ADCC activity.

These aforementioned effects were without any adverse

changes to various structural or functional attributes of

multiple recombinant human antibodies and a bispecific

DVD-Ig. The glycoengineering approach was very efficient

and effective to implement, requiring no cell line

engineering, or cellular adaptation strategies. The

glycoproteins developed represent an expansion of the N-

glycan code in mammalian expressed glycoproteins.

Patrick Hossler, Principal Research Scientist, Process Sciences, Abbvie

Product Quality Modulation

David Bruehlmann, Associate Manager, Merck Biopharma

Page 5: 2017 Speakers Include - Oxford Global Marketing – 7th ... · PDF fileBayer Pharma AG Scheideman, ... Purification Platform Lead TS/MS Eli Lilly • Steffen Sass, Data Scientist,

For more information please contact [email protected]

6th Annual Cell Culture & Bioprocessing Congress Day One – 6th November 2017

12.20 – 12.50

Solution Provider Presentation

For sponsorship opportunities please contact [email protected]

Solution Provider Presentation

For sponsorship opportunities please contact [email protected]

12.50 – 13.50 Lunch

13.50 – 14.20 Vero SF Technology Platform: Strategy For Rapid And Effective Vaccine Development ; Flavivirus Vaccines Case Study • As a world leader in vaccine development, Sanofi

Pasteur has acquired a strong expertise in the development and manufacturing of Vero SF-based vaccines, including against diseases of the Flavivirus family

• To develop this innovative platform and provide a fast response to new viral epidemics, the vaccine manufacturing process development strategies have considerably evolved over the past decade. Toolboxes dedicated to high-throughput development have been designed and optimized to provide rapid response and effective vaccine availability

• For the sake of speed and efficiency, development strategies have been reorganized by platforms. Theses platforms, such as screening, modelling, process monitoring, bioreactor, have themselves been completely redesigned to allow fast implementation of all development phases up to industrial scale

Anne-Marie Beauchard, Principal Scientist, Sanofi

PANEL DISCUSSION: Challenges Of New Purification Approaches In Bioprocessing Invitation to: Matthieu Stettler, Associate Director, Merck Biopharma Jose Gomez, Manager and Principal Scientist, Pfizer Patrick Hossler, Principal Research Scientist, Process Sciences, Abbvie

14.20 – 14.50 PANEL DISCUSSION: Advaces In Emerging Cell Line Enginnering Tools And Techniques Invitation to: Diane Wilkinson, Director Global Regulatory Affairs CMC, Biogen Xiaotian Zhong, Senior Principal Scientist/Lab Head, Pfizer

Anne-Marie Beauchard, Principal Scientist, Sanofi

Toward Late Phase Production And Characterization Of rAAV Vectors Using HAVE • HSV vector scale-up

• AAV vector optimization

• Analytical & characterization advancement

Dave Knop, Director, Process Development, Applied Genetic Technologies Corporation

14.50 – 15.20 Solution Provider Presentation

For sponsorship opportunities please contact [email protected]

Solution Provider Presentation

For sponsorship opportunities please contact [email protected]

15.20 – 16.20 Afternoon Refreshments, One to One Meetings x2, Poster Presentation Sessions

16.20 – 16.50 Integrated Control Strategy For The Production Of A Biopharmaceutical • Interdependencies of upstream with downstream

• The importance of control strategy in regulatory submissions

Gisela Ferreira, Senior Scientist, Late Stage Process Development, Medimmune

Applying A Risk-Based Strategy For Implementing Disposables In A Commercial Manufacturing Process • Implement a risk-based strategy to your manufacturing

process to capitalize of the potential of single-use technology

• Examine the latest trends in risk-management and decide which strategies could work best for your site

• Identify individual risks to your manufacturing process and cultivate smart guidelines for mitigating their effects

• Learn how to ensure that your suppliers maintain strong quality oversight to support their product from a control process and ensure regulatory compliance

Xavier Derouck, Senior Sourcing Group Manager of Bioprocessing, GlaxoSmithKline

Page 6: 2017 Speakers Include - Oxford Global Marketing – 7th ... · PDF fileBayer Pharma AG Scheideman, ... Purification Platform Lead TS/MS Eli Lilly • Steffen Sass, Data Scientist,

For more information please contact [email protected]

6th Annual Cell Culture & Bioprocessing Congress Day One – 6th November 2017

16.50 – 17.20 CHO Host Cell Engineering And Expression

Vector Development To Increase Production And Quality Of Recombinant Proteins • Development of new reporter-based cell lines for clone

screening/selection by FACS

• Study of glycosylation gene profiles in different host cell lines and effects on product

Elizabeth Harker Scheideman, Diretor Cell Line Development, Vaccine Production Program, VRC/NIAID/NIH

Key Hurdles In The Manufacture Of Biologics

Carol Knevelman, Head of Process R&D and Principal Scientist, Oxford Biomedica

17.20 – 17.50 Automation In Cell Line Development Helen Maunder, Senior Scientist, Oxford Biomedica

Overcoming PAT & QbD Challenges Rhian Carter, Team Leader, Process R&D Scientist, Oxford Biomedica

17.50 – 18.20 Stem Cell Bioprocessing: The Role Of Metabolism And The Use Of Metabolomics • The central role of metabolism in modulating stem cell

behaviour

• The use of metabolomics as the quality control monitoring tool

Sakis Mantalaris, Head of Biological Systems Engineering Laboratory Group and Professor, Imperial College London

Simplifying Dynamic Mechanistic Modelling for Optimisation of Cell Process Development and Manufacture • Identification of the types of dynamic that make cell

culture processes challenging to optimise and control

• Introduction of a workflow and toolset to support definition and optimisation of cell culture

• Case studies of process improvement opportunities

Robert Thomas, Reader and EPSRC Early Career Fellow,Wolfson School of Mechanical and Manufacturing Engineering, Loughborough University

18.20 – 18.50 Cell Culture Systems: Novel, Important And Direct Targets For Both Cancer And Anti-ageing Therapies

Parmjit Jat, Professor of Neurodegenerative Disease, University College London

18.50 End of Day One and Networking Drinks

Page 7: 2017 Speakers Include - Oxford Global Marketing – 7th ... · PDF fileBayer Pharma AG Scheideman, ... Purification Platform Lead TS/MS Eli Lilly • Steffen Sass, Data Scientist,

For more information please contact [email protected]

6th Annual Cell Culture & Bioprocessing Congress Day Two – 7th November 2017

Conference Room

Stream Chair

08.30 – 09.00 Keynote Address: Manufacture And Logistics Of Next Generation Therapeutics

Eric J. Wallenstein, Associate Director, Global Technical Operations-External Biologics Manufacturing, Merck & Co., Inc.

Cell Line Development Biological Production & Bioprocessing

09.00 – 09.30 Stream Keynote Address: Host Cell From Scratch: From KO To Large Scale • CHO Host cell

• GS selection system

• Biopharmaceutical Manufacturing

Markus Michael Müller, Associate Director Cell Culture Development, Boehringer Ingelheim

Stream Keynote Address: Outsourcing Biologics CMC Development And Manufacturing – The Benefits And Challenges • The crucial make or buy question

• Best practices for a successful CDO / CMO partnership

• Understanding and mitigating the risks in outsourcing

• How to protect your IP?

• Success factors to establish an efficient partnership

Ulrich Ruemenapp, Head of Launch Preparation and Coordination, Bayer Pharma AG

09.30 – 10.00 Solution Provider Presentation

For sponsorship opportunities please contact [email protected]

Solution Provider Presentation

For sponsorship opportunities please contact [email protected]

10.00 – 11.00 Morning Coffee & Refreshments, One to One Meetings x2, Poster Presentation Sessions

11.00 – 11.30 Optimization Of A Stable CHO-K1 Based Cell Line For FAP-DR5 2+2 CrossMab Antibody In Order To Increase Product Quality And Yield We have generated a recombinant, stable CHO-K1 based cell line for a novel tetravalent FAP-DR5 (2+2 type CrossMab) antibody, which effectively triggers FAP- dependent, avidity-driven DR5 hyperclustering and tumor cell apoptosis. The application of our cell line development platform comprising semi-automation and a diligent cell line selection strategy resulted in final cell clones, which showed a stable product profile and high yield, but side peaks which referred to limitations in crossed light chain expression. In the talk we describe the strategy and execution of targeted cell line optimization leading to a final cell line with improved quality and yield.

Stefan Seeber, Principal Scientist, Dept. Cell Line and Molecule Development, pRED, Roche

Continues Manufacturing And Disposable Sensor Challenges

Vishal Rosha, Fellow, BTDM – Advance Process

and Manufacturing Technologies, Novartis

11.30 – 12.00 Solution Provider Presentation

For sponsorship opportunities please contact

[email protected]

Solution Provider Presentation

For sponsorship opportunities please contact

[email protected]

12.00 – 12.30 Cell Line Development For Expression Of Bispecific And Trispecific Molecules

Valentina Ciccarone, Principal Scientist, Macrogenics, Inc.

Application Of Spray Drying In Bioprocessing • Drying of Large Biomolecules

• Spray Drying vs. Freeze Drying technology

Sune Klint Andersen,Principal Scientist, Drying Processes and Particle Technology in CMC, Novo Nordisk A/S

12.30 – 13.30 Lunch

Page 8: 2017 Speakers Include - Oxford Global Marketing – 7th ... · PDF fileBayer Pharma AG Scheideman, ... Purification Platform Lead TS/MS Eli Lilly • Steffen Sass, Data Scientist,

For more information please contact [email protected]

6th Annual Cell Culture & Bioprocessing Congress Day Two – 7th November 2017

13.30 – 14.00 Stable Producer Cell Lines For Lentiviral Vector

Manufacture • The field of cell and gene therapy can potentially

deliver transformative medicines for patients. The use of viral vectors such as lentivirus is pivotal for the delivery of these novel medicines. However, a realistic industrialisation model for efficient and reproducible viral vector manufacture is required to meet commercial demands

• Transient transfection is the current standard for viral vector manufacturing. Whilst this manufacturing process is efficient it is not reproducible across virus vector batches nor is it cost efficient. Therefore to meet commercial demands, and to drive down costs of development, a concerted effort toward developing a stable manufacturing platform akin to Biopharmaceuticals is desirable

• Process research has been conducted into the potential of creating stable producing cell lines that may be used for lentiviral vector manufacturing. The strategy to deliver these stable cell lines will be captured in my presentation

Christopher Sampson, Investigator, Cell Line Development, Cell & Gene Therapy, GlaxoSmithKline

Process Change Agenda For Biologics: An Approach To Early Post Launch Implementation

Graham McCartney, Purification Platform Lead TS/MS Eli Lilly

Page 9: 2017 Speakers Include - Oxford Global Marketing – 7th ... · PDF fileBayer Pharma AG Scheideman, ... Purification Platform Lead TS/MS Eli Lilly • Steffen Sass, Data Scientist,

For more information please contact [email protected]

6th Annual Cell Culture & Bioprocessing Congress Day Two – 7th November 2017

14.00 – 14.30 Evaluation Of New Single Cell Deposition Technologies For Cell Line Development Of Production Cell Lines • Single cell deposition technologies were tested

together with imaging devices

• Data for Monoclonality assurance were collected

• A possible new workflow with one cloning round was tested and compared to the old process

Anke Mayer-Bartschmid, Senior Scientist Cell Line Development, Bayer

Novel Downstream Purification Approaches

Kristi Daris, Senior Scientist, Amgen

14.30 – 15.00 Increase The Yield Of Commercial Products: Oral Poliomyelitis And Verorab Vaccines • Where are the potential areas for improvement?

Write-offs and step by step process yield review provided by Statistical Process Control

• Test the hypothesis at small-scale (Ambr system)

• Implement the changes at 2000 L scale

Stanislas Augusto, Product/Process Specialist for OPV and Verorab Vaccines, Sanofi Pasteur

Comparison Of Bolus And Continuous Feed Strategies For A Cho-K1 Cell Line • A balanced nutrient supply has been shown to

increase the cell specific productivity (qP) while maintaining the product quality

• This study looked into different feeding regimes by shifting the sequence of the bolus feeds and using continuous feed strategies

• The results provided insights into the cell specific nutrient requirements and allowed us to establish a balanced feed strategy

Shaymaa El Taieb, Cell Culture Specialist and Scientist, MSAT BioMarin

15.00 – 15.30 Afternoon Refreshments, Poster Presentation Sessions

15.30 – 16.00 Cell Line Authentication And Characterization • Reasons authentication is essential

• Validity of cell lines as models

John Masters, Professor of Experimental

Pathology, University College London

Continuous Process Development • Fed batch vs. novel continuous manufacturing tools

and techniques

• Integrated continuous processing methods

Gilles Joucla, Assocaite Professor, National School of Biomolecular Technologies of Bordeaux

16.0 – 16.30 Advanced Cell Technologies – How Cell Culture Is Destined For Change • Changes to the microenvironment in which cells are

cultured, influences their structure and function;

• Such factors can include the topography of the substrate and justifies the need to maintain the natural 3D structure of cells during cell culture;

• This lecture will focus on the development and application of 3D cell culture technologies and the formation of tissue-like constructs in vitro – for use in basic research, development and safety screening;

• Examples of the application of such technology to stem cell science will also be included;

• Such technologies are changing the way in which cell culture is developing and providing more physiologically relevant data

Stefan Przyborski, Professor, Durham University

Identifying A Roadmap To Allow Process Change From Early Phase To Late Phase Manufacturing • Identifying process parameters per unit operation

• Identifying suitable attributes related to process and product change

• When should changes be introduced

Bastiaan Leewis, MSAT Manager – Industrialisation, Meiragtx

Page 10: 2017 Speakers Include - Oxford Global Marketing – 7th ... · PDF fileBayer Pharma AG Scheideman, ... Purification Platform Lead TS/MS Eli Lilly • Steffen Sass, Data Scientist,

For more information please contact [email protected]

6th Annual Cell Culture & Bioprocessing Congress Day Two – 7th November 2017

16.30 – 17.00 Cell Printing: A Fluidics Approach To Single Cell

Cloning For Manufacturing Cell Lines • The microfluidics-based Single Cell Printer (Cytena)

integrates single cell imaging and deposition into microwell plates and offers a simplified workflow for cell cloning

• We describe a strategy for method development and optimisation including investigation of the culture parameters for the starting transfectant pools, optimisation of the recovery medium and imaging protocols

• The implementation of this novel technology in combination with a high content imaging system results in the isolation of cell lines with a high probability of monoclonality with a single round of cloning, and provides significant advantages over traditional methods with respect to cost, simplicity, timings and flexibility

Clare Lovelady, Scientist I, Medimmune

Application Of Machine Learning Techniques Throughout Process Validation Lifecycle • New approaches for establishment of a

comprehensive process model used within the QbD framework

• Statistical models are generated for gaining holistic process knowledge

• Process understanding is the basis for continued process verification

Steffen Sass, Data Scientist, Roche

17.00 – 17.30 Engineering CHO Cells For Improved Medium Catabolism

Mikael Rørdam Andersen, Associate Professor, Technical University of Denmark

17.30 End of Conference

Page 11: 2017 Speakers Include - Oxford Global Marketing – 7th ... · PDF fileBayer Pharma AG Scheideman, ... Purification Platform Lead TS/MS Eli Lilly • Steffen Sass, Data Scientist,

6th Annual Cell Culture & Bioprocessing Congress Conference: November 2017, London, UK

www.cellculture-congress.com

HOW TO REGISTER: FAX your booking form to +44(0)1865 250985 | PHONE on +44(0)1865 248455 | EMAIL: [email protected]

Please complete fully and clearly. Please photocopy for additional delegates Title:_____Forename:_______________Surname:________________ Job Title:_________________________________________________ Company/Organisation:_____________________________________ Email:___________________________________________________ Address:_________________________________________________ ________________________________________________________ Postcode: ____________________ Country: ___________________ Direct Telephone ________________ Direct Fax: ________________ Mobile: ________________________ Switchboard: _____________ Signature: ______________________ Date: _____________________

Number of delegates:

Industry del(s) Academic dels(s) Vendor dels(s) Special Offer: 3 for 2

Offer is only valid on the congress and for those registering at Industry or Academic rates

CREDIT CARD: Visa MasterCard Maestro Amex Credit Card Number:

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Signature: ______________________________ Date: ___________

PLEASE INVOICE ME:

Invoice Address (if different from above)_______________________

*Please note there is a £50 plus VAT handling charge for payment via invoice *All card payments will be subject to a 3% bank charge or 4% AMEX charge

Registration Fees

Agreed Terms between the Organiser (Oxford Global Marketing Ltd) and the Delegate: Delegate Booking Fee The Delegate Booking Fee includes: lunches and refreshments throughout the Congress event, conference presentations, workshop and panel sessions, scheduled one-to-one meetings and networking/social events, conference and speaker notes. Delegates may attend, free of charge, all sessions arranged by the Organiser. An admin surcharge of £50 + VAT will be applied to payments settled following the receipt of an invoice. This charge will not be applied to pay-ments settled online. Vendor Delegates will not be eligible for one to one meetings unless they purchase a sponsorship meetings package. These can only be purchased directly from Oxford Global Marketing Ltd and not via the online booking facility. Poster Presentations Those who have booked a poster presentation at the event must provide the poster title, abstract (200 words or less), principal author, organisation, mailing address, email, telephone, fax and additional authors, within a month of registration. All poster spaces will be for A0 (841mm x 1189mm) portrait size. Cancellation and Curtailment Delegates and vendor delegates are subject to the following charges and refunds upon withdrawal or cancellation. More than 6 months prior 35% cancellation fee / 65% refund Between 6 and 3 months prior 75% cancellation fee/ 25% refund Less than 3 months prior to the event Full cancellation fee / No refund Data Protection The data controller is the Organiser. The Organiser may disclose such personal information to Registered Event Sellers (Solution Providers) and other Delegates but solely for the purposes of the Event. The Delegate consents to the use of his/her personal and company information on the terms set out herein. Miscellaneous This Agreement may not be transferred or assigned by either the Delegate or the Delegate’s Company. The Organiser will determine the scope and content of Congress conference events, seminars, workshops and activities throughout the Event. The Organiser reserves the right to cancel the Event without liability to Delegate’s Company or individual Delegate. If for any reason the Organiser has to cancel or postpone this Event, the Organiser reserves the right to transfer this Booking to another Congress within the same sector to be held within twelve months. Should another Congress in the same sector not be available within this period, the Booking Fee will be refunded. I agree to the above Terms and Conditions

How to Pay (choose one of the following payment options)

I would like to attend: (Please tick as appropriate) Industry Delegates (Biopharma, Pharma or Biotech Companies)

Congress £799 plus VAT 1 day pass £499 plus VAT Day 1 Day 2

Academic Delegates Congress £499 plus VAT 1 day pass £299 plus VAT Day 1 Day 2

Vendor Delegates (CROs, Consultants, Technology and Service Providers) Congress Only £1350 plus VAT

1 day pass £799 plus VAT Day 1

Day 2 Poster Presentation £250 plus VAT PROMOTIONAL LITERATURE DISTRIBUTION

Distribution of your company’s promotional literature to all conference attendees £999 plus VAT

Documentation

I cannot attend but would like to purchase access to the following: Access to the online conference presentations £499 plus VAT Conference presentations - paper copy £499 plus VAT

VAT is charged at 20% on the attendance fees for all delegates. VAT is also charged on online and paper copy documentation and promotional literature distribution for all UK customers and for those EU customers not supplying a registration number for their own country here.

If you have any further queries please call the marketing team on +44(0)1865 248455 or email [email protected]

Terms & Conditions of Booking

Delegate Details