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Key Sessions

Martin Allen

Rapid Development of Cell Lines Suitable for Commercial Manufacturing

Pfizer

Nathan Lewis

KEYNOTE: Engineering Complex Traits in CHO Cells through Multiplex Genome Editing

University of California, San Diego

07:30 - 08:50 80 mins
Registration
08:50 - 09:00 10 mins
Chairperson's Opening Remarks
09:00 - 09:30 30 mins
Continuous Manufacturing Cell Line and Clone Selection Strategies
Adapting Cell Line and Clone Selection Methods and Workflows for Continuous Manufacturing
  • Christine DeMaria - Director, Cell Line Development, Sanofi
09:30 - 10:00 30 mins
Info
Accelerating Cell Line Development
Accelerating timelines close to the biological limit: A story about the value of implementing novel technologies
  • Thomas Jostock, PhD - Science and Technology Lead / Novartis Leading Scientist, Novartis Pharma AG

State of the art CHO platforms allow generation of high yielding production cell lines with short cycle times. Our technology development strategy combines efforts for further optimizing speed and yield of our CHO platform with continuous expansion of our technology toolbox to deal with challenging molecules and special requirements. By integrating vector and cell line technologies we are aiming for further reducing cycle times and screening efforts of cell line development. Some novel technologies that we have implemented to improve our platform and to expand our technology toolbox will be presented.

10:00 - 10:30 30 mins
Accelerating Cell Line Development
Spotlight Presentation
  • A Representative from Lonza - *, Lonza, Switzerland
10:30 - 11:30 60 mins
Accelerating Cell Line Development
Morning Coffee & Networking
11:30 - 12:00 30 mins
Accelerating Cell Line Development
Case Study from Amgen: Accelerating Cell Line Development
  • Christopher Tan - Scientist, Amgen
12:00 - 12:30 30 mins
Info
Accelerating Cell Line Development
The BEST of Both Worlds – Targeted Integration and Multiple Copies: How Can This Go Together For Improved Cell Line Development?
  • Anton Bauer - Senior Scientist, Medical University of Vienna

Targeted Hot Spot integration and multiplication of independent expression units – can this go together and even speed up cell line development? By targeting the Rosa26 Hot Spot in vitro we generated BAC-based expression vectors, which integrated in multiple copies into the CHO host cell chromatin and acted as independent expression units. This allowed us to adapt the selection process and developed long-term stable high-yield production cell lines at an unprecedented speed.

12:30 - 12:45 15 mins
Accelerating Cell Line Development
Spotlight Presentation
  • A representative from Valitacell - -, Valitacell
12:45 - 13:00 15 mins
Accelerating Cell Line Development
Spotlight Presentation
  • A Representative from Batavia Biosciences - -, Batavia Biosciences
13:00 - 13:30 30 mins
Accelerating Cell Line Development
Lunch In The Exhibition Hall
13:30 - 14:15 45 mins
Accelerating Cell Line Development
Live Labs
14:15 - 14:45 30 mins
Info
Accelerating Cell Line Development
End-to-end Workflow Platform to Speed Up Cell Line Development at Highest Quality Standards
  • Christoph Freiberg - Senior Scientific Consultant, Biologics, Genedata

We have developed an E2E platform that supports the entire bioprocess development workflow by automating cell line development and managing upstream process (USP), downstream process (DSP), analytical and formulation development. The system directly integrates with instruments and enables informed decision-making via its query and reporting infrastructure. We present efficiency and quality gains obtained using the cell line and upstream process development modules of the platform.

14:45 - 15:15 30 mins
Accelerating Cell Line Development
Reducing Cell Line Development Timelines and Increasing Speed to Clinic
  • Eva Rubio-Marrero - Scientist I, CLD, Drug Substance-Biologics, Celgene Corp
15:15 - 15:45 30 mins
Info
New Technologies for Faster and Easier Clone Production and Selection
Scalable, Helper Virus-Free AAV Production in Suspension
  • Silke Wissing - Vice President R&D, CEVEC

CEVEC has developed a helper virus-free suspension AAV production platform on the basis of the CAP-GT cells. These human suspension cell lines grow to high density in serum free conditions and allow reproducible and high titer production of viral vectors. CEVEC’s stable AAV packaging/producer cell lines enables a consistent quality production of AAV vectors that abolishes the need for transient transfection or helper-virus transduction.

15:45 - 16:15 30 mins
New Technologies for Faster and Easier Clone Production and Selection
Afternoon Coffee & Networking
16:15 - 16:45 30 mins
Info
New Technologies for Faster and Easier Clone Production and Selection
Making the Most Out of the Data Collected along the CLD Process
  • Anke Mayer-Bartschmid, - Cell and Protein Sciences, Pharmaceuticals Division, , Bayer Pharma

High titers and good product quality are the key features a final production cell line needs to have. Besides many other quality attributes a consistent track record and data integrity are essential to launch the cell line for production. Furthermore, the availability of screening data during cell line development allows for fast analysis and the selection of the best clones. We will present Bayer’s way for tracking and analysis of clone selection data.

16:45 - 17:15 30 mins
Info
New Technologies for Faster and Easier Clone Production and Selection
Rapid Development of Cell Lines Suitable for Commercial Manufacturing
  • Martin Allen - Senior Director, Cell Line Development, Pfizer

Cell line development to support early phase clinical programs is often performed on rapid timelines, recognizing that it may be necessary to develop a new cell line to support commercialization if the programs advances to that stage.  This presentation will focus on technologies and strategies that enable the most rapid development of an early phase cell line that is also suitable for commercial manufacturing (single cycle cell line development).            

17:15 - 17:45 30 mins
Info
New Technologies for Faster and Easier Clone Production and Selection
KEYNOTE: Engineering Complex Traits in CHO Cells through Multiplex Genome Editing
  • Nathan Lewis - Assistant Professor, University of California, San Diego

CHO remains the primary host cell for producing most biotherapeutics. However, there remain many traits that could be improved in the cells. Here, I will discuss recent work in our lab were we utilized systems biology approaches to identify genes to target for host cell engineering to improve cell line and bioprocess quality.

17:50 - 18:20 30 mins
Info
New Technologies for Faster and Easier Clone Production and Selection
Industry 4.0 in Aviation – Digitalization without beta versions
  • Sven Taubert - Head of Corporate Foresight & Market Intelligence, Lufthansa Technik AG

Topics like Digitalization and Industry 4.0 are currently on everyone's minds. New economy companies revolutionizing more and more classical business models. Aviation, like other safety sensitive industries, is working hard to keep up. Unlike services from the big role models out of e.g. Silicon Valley, aerospace products cannot and will not shipped in Beta status. This presentation will show examples how Lufthansa is addressing these challenges.

18:20 - 19:50 90 mins
End of Conference Day Two and Evening Party
07:30 - 08:50

Registration

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08:50 - 09:00

Chairperson's Opening Remarks

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Showing of Streams
Showing of Streams
Showing of Streams
18:20 - 19:50

End of Conference Day Two and Evening Party

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