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Key Sessions

Valentina Ciccarone

Cell Line Development Strategies for Bispecific and Multi-Specific Proteins

MacroGenics, Inc.

Mark (Mao Xiang) Chen

High Titre Stable Suspension Lentiviral Vector Producer Cell Lines Using Bacterial Artificial Chromosome (BAC)

GlaxoSmithKline R&D

08:30 - 09:10 40 mins
Registration Opens
09:10 - 09:20 10 mins
Chairperson's Opening Remarks
09:20 - 09:50 30 mins
Cell Line Development for Novel Modalities and Difficult to Express Proteins
Overcoming the Challenges of Cell Line Development and Engineering for Difficult to Express Proteins
  • Martin Gamer - Associate Director, Early Stage Bioprocess Development, Boehringer Ingelheim Pharma GmbH & Co. KG
09:50 - 10:20 30 mins
Cell Line Development for Novel Modalities and Difficult to Express Proteins
Cell Line Development Strategies for Bispecific and Multi-Specific Proteins
  • Valentina Ciccarone - Principal Scientist, Cell Line Development, MacroGenics, Inc.
10:20 - 10:50 30 mins
Cell Line Development for Novel Modalities and Difficult to Express Proteins
Spotlight Presentation
  • A Representative from ALS, ALS
10:50 - 11:30 40 mins
Cell Line Development for Novel Modalities and Difficult to Express Proteins
Morning Coffee Break
11:30 - 12:00 30 mins
Info
Cell Line Development for Novel Modalities and Difficult to Express Proteins
Highlights from the process development of GBR 310, Glenmark’s biosimilar for Xolair
  • Martin Bertschinger - Deputy Director Cell Sciences, Glenmark Pharmaceuticals SA.

Glenmark’s biosimilar of Xolair (omalizumab), GBR 310, is currently under clinical evaluation. The development of a process for manufacturing of a biosimilar molecule is highly challenging, as critical quality attributes are influenced by multiple factors (in particular by the cell line development process and the upstream process). For the development of GBR 310, Glenmark has developed a strategy that allowed the manufacturing of omalizumab matching a quality target profile pre-defined by the Innovator molecule Xolair.

12:00 - 12:30 30 mins
Info
Cell Line Development for Novel Modalities and Difficult to Express Proteins
High Titre Stable Suspension Lentiviral Vector Producer Cell Lines Using Bacterial Artificial Chromosome (BAC)
  • Mark (Mao Xiang) Chen - Manager, Cell Line Development, Cell and Gene Therapy CMC,, GlaxoSmithKline R&D

Lentiviral vectors are showing success as delivery vehicles for gene therapy, however, suppling sufficient quantities of clinical grade vectors remains challenging. To overcome some of the limitations of current 4 plasmids transient transfections GSK has established a technology to produce stable lentiviral vector producer cell lines from a single large BAC construct, and manufacture in suspension culture in large bioreactors.

12:30 - 13:00 30 mins
Info
Cell Line Development for Novel Modalities and Difficult to Express Proteins
Rapid HeLa based Producer Cell Line Development for Scalable rAAV Production
  • Aubrey R Tiernan - Senior Scientist, Head of Cell Line Development, Ultragenyx Pharmaceuticals, Inc

One challenge for cell line development in industry is to generate highly productive stable cell lines within the shortest time frame possible.  This presentation will cover lessons learned over three years in establishing a robust, high throughput HeLa suspension screening platform to generate stable monoclonal producer cell lines suitable for Phase III clinical trial/commercial rAAV production.

13:00 - 13:30 30 mins
Assuring and Proving Monoclonality
Novel Approaches and Technology Implementation to Demonstrate Assurance of Clonality
  • A Representative from Cytena - -, Cytena
13:30 - 14:45 75 mins
Assuring and Proving Monoclonality
Lunch
14:45 - 15:15 30 mins
Info
Assuring and Proving Monoclonality
Accelerating Cell Line Development using Transposase-Mediated Integration and Verified In-Situ Plate Seeding
  • Angela Tuckowski - Associate Scientist, Janssen R&D Cell & Developability Sciences Group

The Janssen R&D Cell Line Development group has partnered with ATUM to evaluate their transposase-mediated integration system, which allows us to generate higher producing transfection pools and limit the need for downstream screening.  We have also partnered with Solentim to evaluate their Verified In-Situ Plate Seeding (VIPS) system, which allows us to seed and image single cells in microtiter plates to assure monoclonality in a single imaging step. These additions have resulted in a more efficient and accelerated cell line development process.

15:15 - 15:45 30 mins
Info
Assuring and Proving Monoclonality
Cytena Single Cell Printer: Getting from Implementation to Robust Cloning Process
  • Kerensa Klottrup-Rees - Scientist II, Cell Culture and Fermentation Sciences, MedImmune

Integrating a new technology is never a simple switch, it impacts the whole workflow. Here we share how we took on the process of optimising many aspects around the introduction of the Cytena Single Cell Printer for single cell cloning to ensure we were able to robustly deliver cell lines for a range of molecules from the portfolio.

15:45 - 16:15 30 mins
Info
Evaluating and Predicting Cell Line Stability
Panel Discussion: Strategies to Evaluate and Improve Cell Line Stability
  • What things affect cell line and clone stability?
  • How to use information on genome stability to produce more stable cell lines?
  • Strategies to evaluate long term cell line stability
  • Development of predictive models for cell line stability assessment in early stage development
  • New technologies to predict clone stability
16:15 - 17:45 90 mins
Evaluating and Predicting Cell Line Stability
Opening of Exhibition Hall & Networking Drinks
08:30 - 09:10

Registration Opens

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09:10 - 09:20

Chairperson's Opening Remarks

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