Continuous Processing in BioManufacturing

25th – 26th April 2017
by invitation only..

Continuous Processing in BioManufacturing

25th – 26th April 2017
by invitation only..


Speakers

1

Dr Barbara Paldus
Chairperson & CEO and Co-Founder

7

Uwe Gottshalk
CTO

6

Dr Berthold Bodeker
Chief Scientist

6-bayer

4

Fjalar Kristjansson
Chief Operating Officer

4-alvo

Jon Coffman
Director of Bioprocess Engineering

2-boeh

Carrier Li
Director

3-amgen

5

Nabil Lawandy
Chairman, President & CEO

5-spec

David Valentine
Senior Principal Scientist, Manufacturing Science and Technology

Marc Better
VP, Product Sciences

Maaike Poppema
Product Development Engineer

Dawid Suwała
Mammalian Cells Bioprocess Coordinator

Emmanuelle Lepine
General Manager

Adriana Kiędzierska-Mencfeld
Production Director

Alexander Marson
Assistant Professor, Microbiology and Immunology

Jonathan Souquet
Head of Biotech Process Science Technology & Innovation

Ohad Karnieli
CEO and Co-Founder

Elizabeth Mily
MD & Chairman of Global Life Sciences Investment Banking Division

Nina Bauer
Commercial Development, Autologous Manufacturing

John Taylor
President and Principal, Compliance and Regulatory Affairs

Claire Walsh
BioProcess Specialist, Cell Culture Operations,

Mark Stevenson
President of Life Science Solutions


DAY 1

Day One

Tuesday 25th April

7.30 – 8.30

Registration

8.30 – 8.40

Welcome from our CellWorld Chairperson and an Introduction

8.40 – 9.15

Life sciences market overview

  • Investors perspective on the current state of the Pharma and Biotech Sectors
  • Generics and biosimilars segment
  • Navigating market dynamics
  • Deep analysis of the myths, misconceptions and realities of investment in the sector
  • Perspectives on the future of life science investment

Elizabeth Mily, Managing Director, Barclays Investment Bank (USA)

9.15 – 9.50

Change is accelerating – the future in Bioprocessing

  • Emerging global trends in advanced manufacturing
  • The impact of new developments and their potential to deliver more cost effective processes
  • A look at continuous manufacturing, new single-use systems and alternative downstream processing techniques
  • Paving the way for personalized treatment options

Uwe Gottschalk, CTO, Lonza (Switzerland)

9.50 – 10.25

Evolutionary and revolutionary process intensification

  • Fed batch intensification using “HIPDOG” glucose feeds, N-1 perfusion, and “HIPCOP” control of perfusion
  • Revolutionary perfusion in the production bioreactor and a integrated downstream

Jon Coffman, Director of Bioprocess Engineering, Boehringer-Ingelheim (USA)

10.25 – 11.00

Coffee Break

11.00 – 11.35

Process Intensification Enabling Technologies

  • The objective of this presentation is to review Business and Market pressures driving the industry towards more efficient and effective manufacturing models and to provide insight into enabling technologies and methodologies that can address these challenges.
  • Upstream process trends will be reviewed and case studies presented to highlight impact on cost of supply, facility capacity and risk mitigation towards uncertainty.
  • Downstream process bottlenecks and their impact of facility utilization and productivity will be addressed and emerging technology solutions presented.
  • Capability needs, technology gaps and implementation challenges will also be summarised

Jonathan Souquet Ph.D., Head of Biotech Process Science Technology & Innovation, Merck (Switzerland)

11.35 – 12.10

Customized Single-Use Bioreactors for a new vaccine production plant

  • Background of the new vaccine production plant
  • High-level overview of vaccine production process
  • Challenges and solutions for single-use bioreactor design
    – Cell retention system
    – Waste removal

Maaike Poppema, Product Development Engineer, Janssen Biologics (Netherlands)

12.10 – 12.45

Engineering Human T Cell Circuitry

  • CRISPR/Cas9 has facilitated genome engineering in many cell types, but in human T cells Cas9 efficiency had been limited and Cas9 had not allowed targeted nucleotide replacements
  • To highlight a CRISPR/Cas9-based platform that enables both knock-out and knock-in genome editing in primary human T cells by electroporation of Cas9:single-guide RNA ribonucleoproteins (Cas9 RNPs)
  • Cas9 RNPs paired with homology-directed repair (HDR) template oligonucleotides can generate a high frequency of knock-in targeted genome modifications in primary T cells
  • The technology enables unprecedented explorations of genetic mechanisms that control T cell function and HIV pathogenesis
  • To understand how sequence variation throughout the human genome affects T cell circuits in health and disease

Alexander Marson, Assistant Professor, Microbiology and Immunology, UCSF School of Medicine (USA)

12.45 – 13.45

Lunch, Finesse Technology Spotlight

13.45 – 14.20

Overcoming Challenges for Engineered Autologous T Cell Therapy

  • CAR T-cell therapies have created considerable excitement within the medical/scientific community due to spectacular early clinical success in difficult-to-treat hematological cancers
  • Manufacturing processes for engineered autologous T cell products are complicated by the inherent variability in cellular starting material
  • Ensuring manufacturing success requires careful development of robust processes, complex relationship with suppliers and a well-trained production organization
  • Simple, robust manufacturing steps are designed to ensure that T cell products remain active, retain appropriate biologic activity and are generated rapidly at low cost
  • We will focus on how to develop and commercialize CAR-T cell products

Marc Better, VP, Product Sciences,  Kite Pharma (USA)

14.20 – 14.55

Out of the box strategies and innovative solutions to bring cell therapies to market.

  • Overview of the cell therapy industry 2017 update
  • Challenges in Cell therapy commercialisation
  • Innovative solutions for cell culturing
  • Automation and scale out

Ohad Karnieli (PhD, MBA), CEO, Atvio Biotech (Israel)

14.55 – 15.30

Future Vision of building a Biologics (DS/DP) Manufacturing Facility in 6 months.

  • Business requirements driving this need.
  • How technology is enabling this reality.
  • Case Study: a journey from Ideation to Reality for a Flexible Manufacturing Plant
  • What a responsive and efficient supply chain looks like
  • How to promote a culture of innovation within Engineering

Carrier Li, Director, Amgen (USA)

15.30 – 16.05

Process Automation for Autologous Manufacturing – a mid-term view on commercial sustainability

  • Autologous manufacturing scope
  • Commercial implications
  • Unit operations and cost drivers
  • Cocoon technology – capabilities and must-haves
  • Initial data review

Nina Bauer, Commercial Development, Autologous Manufacturing, Lonza (Switzerland)

16.05 – 16.45

Coffee Break/Refreshments

16.45 -17.30

Panel Discussion
The Road to Personalized Medicine

  • Personalized or ‘precision’ medicine is on the rise, due to advancements in, and the emerging integration of, biology, biotechnology, DNA sequencing, IT, and IoT.
  • How do we address ever-increasing the costs of care?
  • What are regulatory challenges and Manufacturing Challenges?
  • What happens to health insurance?
  • This panel discussion will address these crucial questions in achieving personalized medicine with experts from the state and businesses.

Mark Stevenson, President of Life Sciences Group, Thermo Fisher Scientific (USA)
Alexander Marson, Assistant Professor, Microbiology and Immunology, UCSF School of Medicine (USA)
Marc Better, VP, Product Sciences, Kite Pharma (USA)
Maninder Hora, SVP, Pharmaceutical Development & Manufacturing, Nektar Therapeutics (USA)

17.30

Chairperson’s Closing Remarks for Day

17.40

Close of Day One

18.50

Cocktail Reception

19.35

Evening Banquet

19.35 – 20.10

Evening Banquet Presentation
Colloidal Nonlinear Optics for Pico-liter Protein Characterization

  • Nonlinear optics using optical forces for protein characterization
  • Determination of size, conformation, and dielectric signatures
  • Potential for determining parameters in seconds
  • Implementable with pico-liter volumes of lysates

Nabil M. Lawandy Chairman, President & CEO, Spectra Systems Corporation (USA)

DAY 2

Day Two

Wednesday 26th April

8.30 – 8.40

Welcome from our CellWorld Chairperson, a summary of Day One and an Introduction to Day Two

8.40 – 9.10

The Presidential and Congressional Elections Impact on FDA

  • What are the major implications for FDA?
  • What are the issues that may impact the performance of FDA?
  • What are the factors that will impact FDA leadership in 2017?
  • What are the issues that may impact FDA’s quality and compliance priorities and functions?
  • Will the election result in fundamental change in FDA’s priorities?

John Taylor, President and Principal, Compliance and Regulatory Affairs, Greenleaf Health Inc. (USA)

9.10 – 9.45

Opportunities and limits of continuous Processing

  • The drivers for continuous processing
  • Most common perfusion approaches and their pro’s and con’s
  • How to implement perfusion fermentation into downstream operations to create fully integrated continuous processing
  • How is a batch defined in a continuous process?
  • What are the major risks and gaps?
  • Upgrading facilities to handle continuous processing versus build new facilities

Berthold Bodeker, Chief Scientist, Bayer Pharma AG (Germany)

9.45 – 10.20

Single Use Bioreactor Scale up: Introduction of a 2000L SUB in 12 months

  • Business case for 2000L SUB train – clinical capacity constraint etc.
  • Background on the Design of the 2000L SUB Suite
  • Engineering run and scale up data (including Ramen data)
  • Comparison between Stainless Steel Manufacturing and Single Use Technology

Claire Walsh, Manufacturing Process Specialist, Janssen Sciences (Ireland)

10.20 – 10.55

SmartFactory in action: A year later, Alvotech’s State-of-the-art manufacturing and lab facility

  • Alvotech, company introduction
  • The challenge of rapid expansion of production capacity using multiple 1,000 L and 2,000 L single-use bioreactor trains.
  • Leveraging cutting-edge automation, enabling higher yields, reducing labour and capital expenses whilst maintaining flexibility in operations management systems.
  • Introducing a SmartFactory platform, which features an open architecture enabling flexibility to develop and manufacture an impressive line-up of biosimialr products.
  • Using Smart technology in process control, batch automation and data management.
  • Integrating upstream and downstream automation for quick transfer without compromising on costs and cycle times.

Fjalar Kristjansson, Chief Operating Officer, Alvotech (Iceland)

10.55 – 11.25

Coffee Break/Refreshments

11.25 – 12.00

Biosimilars: Trends, Benefits and Challenges

  • mAbxience presentation
  • Current global trends and market position
  • Exploring opportunities for biosimilar development and commercialization vis-a-vis healthcare reform and rising costs
  • With drug pricing pressure how can bio manufactures increase production, yields, characterization, economics, and quality
  • Quality considerations for biosimilar development
  • New developments in the regulatory framework for approving biosimilars globally
  • What does the future hold?

Emmanuelle Lepine, General Manager, mAbxience (Spain)

12.00 – 12.35

Disposable technology in manufacturing of biosimilar monoclonal antibodies

  • Disposable or stainless steel – project start decision.
  • Which supplier for process to choose – decision drivers.
  • How to keep quality and similarity of product using disposable technology
  • Management view on process costs in Production scale
  • Laboratory scale and production scale – how to align.

Adriana Kiędzierska-Mencfeld, Production Director, Polpharma Biologics (Poland)

12.35 – 13.10

Case study: Tech transfer of mammalian cell culture process from lab scale to production scale using disposable technology.

  • Process development in lab scale – AMBR system, flasks and glass bioreactors
  • Tech transfer GAP analysis – risk evaluation
  • Process scale up to 50L single use bioreactor
  • Process scale up from 50 to 250L single use bioreactor
  • Final scale 1000 L in single use bioreactor
  • Process expansion – second 1000L bioreactor

Dawid Suwala, Mammalian Cells Bioprocess Coordinator, Polpharma Biologics (Poland)

13.10 – 13.45

Network Lunch

13.45 -14.20

Data Integrity on the Shop Floor – How Proper Production Control and MES enable right first time

  • Define what a proper Production Control Strategy is
  • Show how the Production Control Strategy drives Data Integrity
  • Identify the organization and technical elements that are critical to driving the Production Control Strategy and improving Data Integrity
  • Demonstrate where Electronic Systems like MES become a key enabler of Production Control and increase Right First Time

Werum TBC

14.20 – 14:55

“Disposables are Not Something to Throw Away (Why Single-Use Is Here to Stay!)”

  • How bioprocessing steps have been transformed by single-use over the last two decades.
  • What has worked well, not so well, and how the assumed benefits of single-use have transpired in practice.
  • What are the transient elements of a single-use plant, and what are the more permanent aspects to consider for consumable ware and hardware. How this enables a facility that is both flexible and future-proofed.
  • How ‘universal’ control systems help standardise data capture and analysis systems and provide a future design blueprint that can be applied across the plant. A concept most easily implemented and sustained when component parts are single-use.

David Valentine, Manufacturing Science and Technology, Lonza Biologics (UK)

14.55 – 15.25

Coffee Break/Refreshments

15.25 -16.10

Panel Discussion
Smart Technologies – The next-generation Smart biomanufacturing facility

  • Dramatic increases in yields from cell lines and the increasing popularity of single-use technologies. Will they change the way we look at future bioprocessing facilities and process designs?
  • How will new and emerging smart technologies for bioprocessing impact the industry?
  • Preparing for the future through Smart Technologies. Practical examples.
  • What will it look like in the near future?
  • What role will the regulatory bodies play in shaping facilities in the next 5-10 years?

David Valentine, Manufacturing Science and Technology, Lonza Biologics (UK)
Jon Coffman, Director of Bioprocess Engineering, Boehringer-Ingelheim (USA)
Jonathan Souquet Ph.D. Head of Biotech Process Science Technology & Innovation, Merck (Switzerland)

16.15

Closing Remarks By Chairperson

16.20

Close

Please note: Agenda and speakers are subject to change.

Participant Package Summary

Full access to all summit presentations and keynotes

  • Participation in roundtable/Interactive workshops of your choice
  • All networking activities including drinks reception
  • Lunch and refreshments on all days
  • Summit Directory including detailed information on all attendees
  • Conference documentation online

Note: Solution/service providers are not permitted to register as a participant attendee.

Invitation only.


Register

* indicates required field
Company Information
Participant Information
Additional Participants (optional)
Participant 1
Participant 2
Confirmation
Signed on behalf of client.  
 
I confirm that I have read and I accept the terms & conditions as set out below.
 

TERMS & CONDITIONS

These terms and conditions, together with the order submitted by you, comprise the “Agreement” between you the Participant, and us, the organiser, Global Market Summits Ltd attendance at the Event.

1. Invitation includes

Attendance at the conference sessions pre-arranged by the Organizer. Attendance to all networking lunches and dinner (not including food or drink outside the Event).

The Participant will send the agreed number of attendees to the Event at the venue on the date and will reside at the venue for the duration of the Event. The Participant will be appropriately qualified for attendance. You will be responsible to conduct yourself in a proper and professional manner at all times, adhering to any health & safety, security or other requirement of Organiser. The Participant will indemnify the Organiser against all claims for injury, damages or loss of property incurred by their representative/s at the event. The Participant will attend and participate all Event activities, including workshops, network lunches. The organisers will not be liable to the Participant for any changes in the number or identity of other attendees or for any attendees who do not keep scheduled appointments, not withstanding any other of the terms. All content and other materials provided by or on behalf of organiser at or in relation to event contain copyright, trade marks or other intellectual property rights or organiser or other third parties and Participant shall not allow any other person to copy, modify, adapt or otherwise use such content and materials for any purpose without organiser’s (or the relevant third party’s) express prior written consent.

2. Changes made by Organiser

If event is cancelled by organiser by reason of events or circumstances beyond its reasonable control (including without limitation Acts of God, flood, failure of any material supplier to the Event, or a cancellation by the operators of the Venue), organiser will reschedule Event (to be held within 12 months of original Event).

3. Unable to Attend

If the Participant is unable to attend the Event he/she may nominate a substitute who will be of similar responsibility and business level to attend the Event. Any Substitute Participant is subject to approval by organiser. All Substitutes must agree to abide by these Terms and conditions.

4. Miscellaneous

This Agreement is binding on the parties upon confirmation by Organizer of acceptance of the Order submitted by the Participant. All communication following this Agreement must be in writing and sent by first class prepaid recorded post to the party’s relevant address referred to above or by email to info@gmsummits.com All such notices are deemed to be received within 7 days of dispatch, provided they are properly addressed and, if posted, stamped. Any notice sent by Client by e-mail cancelling this Agreement or attendance at an Event, or disputing any sum.

5. Data Protection Act

We take the protection of your data seriously. The personal data you provide will be kept confidential and used to support your customer relationship with organiser. Data is collected in accordance with the Personal Information Protection & Electronic Documents Act (PIPEDA) and our Privacy Policy which is available on our website. The information provided by Client or Client Representatives, will be held on our database and may be shared internationally with other companies within the same Group as the Organizer. Occasionally your details may be made available to our external partners. If you do not wish to your details to be made available to these carefully chosen companies, please contact the us at info@gmsummits.com

REGISTERED COMPANY DETAILS

Company Number: 7761940

VAT Number: 122 4572 40

Payment Terms: 14 DAYS

NAME OF BANK: BARCLAYS BANK PLC

Account Number: 53769798

Sort Code: 20 41 41

ACCOUNT NAME: GLOBAL MARKET SUMMITS LTD

Swift Code: BARCGB22

IBAN Number: GB97BARC20414153769798

ENGLISH LAW GOVERNS THIS AGREEMENT.


Venue

San Francisco Hilton Hotel

Hilton San Francisco Financial District
750 Kearny Street, San Francisco,
California 94108

T: +1-415-433-6600

W: http://www.sanfranciscohiltonhotel.com/

San Francisco Hilton Hotel