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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 - 08:20 50 mins
Registration
08:20 - 08:30 10 mins
Chairperson's Opening Remarks
  • Miriam Monge - Director of Marketing Integrated Bioprocess Solutions, Sartorius Stedim FMT S.A.S
08:30 - 09:00 30 mins
Continuous Manufacturing Cell Line and Clone Selection Strategies
Moving Cells with Light: Feasibility Studies for Using the BLI Beacon in CLD Workflows
  • Christine DeMaria - Director, Cell Line Development, Sanofi
09:00 - 09:30 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.

09:30 - 10:00 30 mins
Accelerating Cell Line Development
Spotlight Presentation
  • A Representative from Lonza - *, Lonza, Switzerland
10:00 - 11:00 60 mins
Accelerating Cell Line Development
Morning Coffee & Networking
11:00 - 11:30 30 mins
Accelerating Cell Line Development
Case Study from Amgen: Accelerating Cell Line Development
  • Christopher Tan - Scientist, Amgen
11:30 - 12:00 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.

12:00 - 12:15 15 mins
Info
Accelerating Cell Line Development
Novel Analytical Solutions for Cell Line Development
  • Hannah Byrne - Product Manager, Valitacell

Advances in Cell Line Development Technologies centre on improvements in protein expression technologies and new clone sorting, screening and imaging techniques. Valitacell is offering the biopharmaceutical industry novel methods to transform the complex manufacturing process that produces bio-therapeutic drugs by making it faster than it is today. We aim to fill the gap in the drug manufacturing process, using our fully automatable Quantum fluorescence polarisation technology platform, and our novel ChemStress technology, and, provide answers to key questions as early as possible in order to promote the chance of identifying high producing, stable cell clones in a reduced time-frame.

12:15 - 12:30 15 mins
Accelerating Cell Line Development
Plasmid technology for increased product yields in CHO cells
  • Sagrario Arias Rivas - Program Manager & Scientific Liaison, Batavia Biosciences
12:30 - 13:00 30 mins
Accelerating Cell Line Development
Lunch In The Exhibition Hall
13:00 - 13:45 45 mins
Accelerating Cell Line Development
Live Labs
13:45 - 14:15 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.

14:15 - 14:45 30 mins
Info
Accelerating Cell Line Development
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).            

14:45 - 15:15 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.

15:15 - 15:45 30 mins
New Technologies for Faster and Easier Clone Production and Selection
Afternoon Coffee & Networking
15:45 - 16:15 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.

16:15 - 16:45 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.

16:50 - 17:20 30 mins
Info
New Technologies for Faster and Easier Clone Production and Selection
Enhanced biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing
  • Jean-Marc Cappia - Group Vice President Marketing & Product Management, Sartorius Stedim Biotech

Key objectives:

The presentation provides an overview of the challenges associated with the increasing adoption of single-use systems (SUS) in vaccines manufacturing and outlines a supply chain and quality strategy where raw material specifications and end to end process controls achieve more consistent biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing.

Bas du formulaire


Abstract

Vaccines manufacturing processes are diverse and complex and require strong commitment to quality for every raw materials and process equipment. With single becoming mainstream technology in commercial manufacture of modern vaccines, there is an increasing reliance on supplier quality and growing regulatory and industry requirement for more transparency on supplier’s quality system and supply chain. Single use suppliers are expected to better characterize their materials and processes, control the variability, understand the impact on vaccine quality and continuously improve their quality systems.

The presentation introduces an integrated supply chain and quality by design strategy whereby SUS integrators partner with polymer and film suppliers to combine material science, film extrusion and bag making expertise. These collaborations help optimize the resins and films and provide better knowledge, specifications and controls of the entire manufacturing process. This in turns allows an in depth characterization and control of extractable substances and particles profiles.

The presentation outlines how establishing resin specifications, film extrusion design spaces and quality agreements can significantly reduce raw material variability, provide consistent biocompatibility and improve product robustness and integrity. End to end process control also enhances assurance of supply and change control.



Audience take-home messages:

  • Resin specification and film design space reduce material variability and improve product quality
  • Control of raw materials and processes enhances single use product biocompatibility & integrity
  • End to end process control also improves assurance of supply and change control for single use products
17:20 - 17:50 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.

17:50 - 19:20 90 mins
End of Conference Day Two and Evening Party
07:30 - 08:20

Registration

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08:20 - 08:30
Info

Chairperson's Opening Remarks

  • Miriam Monge - Director of Marketing Integrated Bioprocess Solutions, Sartorius Stedim FMT S.A.S
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Showing of Streams
Showing of Streams
Showing of Streams
17:50 - 19:20

End of Conference Day Two and Evening Party

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