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

1-finesse

7

Uwe Gottshalk
CTO

7-lonza

6

Dr Berthold Bodeker
Chief Scientist

6-bayer

4

Fjalar Kristjansson
Chief Operating Officer

4-alvo

2

Jon Coffman
Director of Bioprocess Engineering

2-boeh

3

Carrier Li
Director

3-amgen

5

Nabil Lawandy
Chairman, President & CEO

5-spec

David Valentine
Senior Principal Scientist

7-lonza

Marc Better
EVP R&D

Mark Selker
CTO

1-finesse

Maaike Poppema
Product Development Engineer

Dawid Suwała
Mammalian Cells Bioprocess Coordinator

Andreas Hermann
CEO

Emmanuelle Lepine
General Manager

Adriana Kiędzierska-Mencfeld
Production Director

Alexander Marson
Assistant Professor, Microbiology and Immunology

Umesh Shaligram
Director, Research and Development

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

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Agenda

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DAY 1

Day One Tuesday 25th April
8.00 AM- 9.00 AM Registration
9.00 – 9.10 Welcome from our CellWorld Chairperson and an Introduction
9.10 – 9.45 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
9.50 – 10.25 Smart Continuous GMP BioManufacturing

  • ‘Industrie 4.0’ describes the Fourth Industrial Revolution and becomes an additional success factor for the process industry.
  • Preparing for the future through Smart Technologies providing the BioPharma industry the benefits of Industrie 4.0’s Modular Automation, defined by organizations such as the NAMUR and German ZVEI.
  • Fast and cost efficient adaptation of production lines to changing processing requirements and volumes, as well as the reduced engineering and validation efforts for new facilities, allow for a shorter time to market and lower cost of goods for traditional and continuous GMP bioprocesses.

Barbara Paldus, CEO, Finesse

10.25 – 11.00 COFFEE BREAK
11.05 – 11.40 Effective Development and Manufacturing of Antibody Drug Conjugates

  • Developing a unique supporting infrastructure to meet biopharmaceutical industry standards for safe effective and reliable manufacturing
  • The challenges faced within scale up, safety issues, critical process parameters and technology transfer
  • Addressing the challenges to achieve a robust conjugation processes and ensure employee safety
  • Facility implications and design to handle larger (commercial) batches effectively

Dr. Berthold Bödeker, Chief Scientist, Bayer Healthcare

11.45 – 12.20 Future vision of bio-processing from an engineering perspective

  • Once a decision has been made to increase capacity, what should it cost?
  • Define your tolerance for lowest cost design and construction.
  • The speaker will provide an examination of the Conceptual Design process and Cost Evaluation of capacity, single-use vs. multi-use operations, redundancy, planned expansion and modularity.

Carrier Li, Director, Amgen

12.20 – 13.20 LUNCH, TECHNOLOGY SPOTLIGHT
Continuous Processing Cell Therapy
13.25 – 14.00
Continuous Processing for Pre-Clinical and Clinical Manufacturing: Two Year Review of Balancing Speed, Cost, and Quality

  • Recent efforts made to achieving optimal commercial continuous processing, resulting in ten-fold increases in productivity and lower costs than typical batch processes.
  • Early stage clinical manufacturing, however, has different needs than commercial manufacturing.
  • A launch capable, high productivity mammalian perfusion process appears to be easier to develop than fed batch systems with equivalent productivity.
  • High productivity mammalian perfusion process with a robust, effectively continuous platform downstream can allow the inexpensive production of regulatory toxicology material prior to candidate selection for multiple candidates, shortening the time to the IND by five to eight months.
  • The challenges associated with using continuous processing in early stage clinical supply will be discussed.

Jon Coffman, Global Head Innovation,Technology, Boehringer Ingelheim

13.25 – 14.00
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
  • Will 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
  • Overall goal is 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

14.05 – 14.40
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
    – Etc

Maaike Poppema, Product Development Engineer, Janssen

14.05 – 14.40
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, EVP R&D, Kite Pharma

14.45 – 15.20 The Value of Biobetters

  • There is an increasing interest in biosimilars and biobetters, with the total number of reported development candidates equalling the number of innovative development compounds.
  • Biobetters Vs. Biosimilars
  • Complexities of developing Biobetters compared with Biosimilars
  • Regulatory and scientific considerations
  • Market position and risk potentials

Dawid Suwała, Mammalian Cells Bioprocess Coordinator, Polpharma

15.20 – 15.50 COFFEE BREAK
15.55 – 16.30 Overcoming Barriers faced by the Vaccine R&D Sector in Developing Countries

  • Highlighting the key challenges and lessons learnt
  • Addressing regulatory bottlenecks in vaccine R&D and pathways to overcome these challenges
  • The key drivers and economics for securing R&D funding and how to maximise government incentives provided for R&D

Umesh Shaligram, Director, Research and Development, Serum Institute of India

16.35 – 17.10 Building an Integrated Continuous Manufacturing Platform

  • The objective of this presentation will be to provide invaluable insight into the design and development of a fully integrated platform manufacturing process operated in continuous mode.
  • Challenges of integrating discrete unit operations to create a compact continuous processing drug substance manufacturing solution will be reviewed.
  • Process design considerations and enabling technologies required to monitor, control and optimize the process will be discussed.

Jonathan Souquet, Head of Biotech Process Science Technology & Innovation, Merck

17.15 -17.55 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?
  • What happens to health insurance?
  • This panel discussion will address these crucial questions in achieving personalized medicine with experts from the state and businesses.
17.55 Chairperson’s Closing Remarks for Day One
18.05 CLOSE OF DAY ONE
18.30 COCKTAIL RECEPTION
19.00 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 Lawandy, Chairman, President & CEO, Spectra Systems

19.00 EVENING BANQUET

DAY 2

Time Wednesday 26th April
9.00 AM – 9.10 Welcome from our CellWorld Chairperson, a summary of Day One and an Introduction to Day Two
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
9.45 – 10.20 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

10.20 – 10.50 COFFEE BREAK
10.50 – 11.25 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
11.30 – 12.05 Biosimilars: Trends, Benefits and Challenges

  • Current global trends and Market position
  • Exploring opportunities for biosimilar development and commercialisation 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 in the US
  • What does the Future hold?

Emmanuelle Lepine, General Manager, Mabxience

12.10 – 12.45 A Retrospective on the last decade of single-use technologies

  • Single-use technologies have had a transformative impact on the development and production of biopharmaceuticals in the past 10 years.
  • We now have nearly a decade of combined industry experience covering the benefits of single-use vs. fixed stainless steel.
  • A look back at where we have been and where we are now, current market characteristics and trends to forecasts future developments.
  • Future use in downstream processing, commercial applications and early development activities.

David Valentine, Senior Principal Scientist, Lonza
12.45 – 13.45 Lunch and Closing Remarks By Chairperson
14.15 – 17.00 EXCLUSIVE GENENTECH SITE TOUR, SAN FRANCISCO, CALIFORNIA
17.00  Transport Back to Hotel and Summit Close

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