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Key Sessions

Jean-Marc Bielser

A Comparison of Different Clonal Phenotypes in Perfusion CHO Cell Culture

Merck KGaA

Pamela Pegman

A Single Cycle Cell Line Approach

Pfizer Inc

Apr 25
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08:50 - 09:00 10 mins
Chairperson's Opening Remarks
09:00 - 09:30 30 mins
Cell Line Development and Engineering
Cell Line Selection Challenges for a Perfusion Based Process: Case Study of a Non Antibody Molecule
  • Arna Andrews - Director, Cell Line Development, CSL Limited
more

This presentation will describe a case study which highlights the challenges with the screening and selection of cell lines destined for a perfusion process of a complex non antibody molecule.

These challenges include the lack of a representative small scale perfusion system for clone screening and the inability of standard shake flask stability studies to identify stability issues.

09:30 - 10:00 30 mins
Cell Line Development and Engineering
A Comparison of Different Clonal Phenotypes in Perfusion CHO Cell Culture
  • Jean-Marc Bielser - Scientist, Merck KGaA
more

Merck KGaA is following the global trend of continuous manufacturing. To support perfusion cell culture development, small-scale semi-continuous screening methods were developed. These methods were applied on a set of different clones and compared to real continuous conditions (lab-scale bioreactors). Growth and productivity performance were compared and helped to define a ranking strategy for screening application, specific to perfusion.

10:00 - 10:45 45 mins
Morning Coffee and Poster Tour 1
10:45 - 11:15 30 mins
Cell Line Development and Engineering
Data Driven CLD – Translation of Big Data Information to Enhance Cell Line Selection and Host Cell Engineering
  • Christine DeMaria - Director, Cell Line Development, Sanofi
more
11:15 - 11:45 30 mins
Cell Line Development and Engineering
Product Quality Control Strategy during Cell Line Development for Non-mAb Complex Modalities
  • Zhimei Du - Head / Senior Principal Scientist, Cell Line Development & Improvement, Merck & Co
more

New product-related impurities have been found to accompany non-mAb complex modalities, which usually don’t exist in standard mAb production. Many of these PQAs are related to protein folding and assembly efficiency inside the cell, which impact post-translational modifications directly or indirectly. Our presentation will illustrate the importance of selecting appropriate cell/upstream conditions through screening and/or engineering, as part of quality control strategy to obtain the desired recombinant protein PQA profile.

11:45 - 12:15 30 mins
Cell Line Development and Engineering
Spotlight Presentation: A Representative from Thermo Fisher Scientific
12:15 - 13:15 60 mins
Lunch in the Exhibition Hall and Live Labs
13:15 - 13:30 15 mins
Cell Line Development and Engineering
Whole Genome Sequencing to Study Genetic Changes in Stable CHO Cell Lines
  • Alexandre Regamey - Director, Molecular Biology, Selexis
more

CHO cells are the most frequently applied host-cell system for the industrial manufacturing of recombinant protein therapeutics. The rapid generation and identification of high-producing clones that do not lose their expression capability over time is a major focus of the industry. The use of cytogenetic analysis with next-generation sequencing (NGS) combined to the proprietary bioinformatic tool SUREscan™, allows us to analyze the whole genome of any generated cell line, improving monoclonality assessment and traceability of RCBs. We will show that our CHO-M cell line is chromosomally stable indicating that the SUREtechnology Platform™ generates RCBs with chromosomally stable lineages.

13:30 - 14:00 30 mins
Cell Line Development and Engineering
Fed-Batch Cell Culture in Ambr15 – Scalability & Applications
  • Jolanda Gerritsen - Expert Technology, CLD, Genmab B.V.
more
14:00 - 14:30 30 mins
Cell Line Development and Engineering
High Stringency Selection of High Producer CHO Cells Using a Metabolic Selection Marker
  • Mark Trautwein - Senior Scientist, Bayer AG - Pharmaceuticals Division
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The concept of high stringency selection of cells producing high amounts of a desired protein of interest is well known in the art and different solutions exist. However, many existing solutions exhibit different drawbacks e.g. need to engineer a host cell line or use of an antibiotic. The presentation will introduce a high stringency selection system using an endogenous metabolic selection marker without the need for cell line engineering.

14:30 - 15:00 30 mins
Cell Line Development and Engineering
Application of Automation for Cell Line Screening and Clone Selection
  • Jennitte Stevens - Director, Amgen
more
15:00 - 15:30 30 mins
Cell Line Development and Engineering
Spotlight Presentation: A Representative from Sartorius
15:30 - 16:15 45 mins
Afternoon Coffee and Poster Tour 2
16:15 - 16:45 30 mins
Cell Line Development and Engineering
A Single Cycle Cell Line Approach
  • Pamela Pegman - Sr Principal Scientist, Cell Line Development, Biotherapeutics Pharm. Sci, Pfizer Inc
more

The ability to generate cell lines capable of supporting both early and late stage clinical as well as commercial programs requires a holistic cross-functional approach to assessing cell line suitability. By leveraging an integrated manufacturability assessment and cell line and process development platforms we have proposed such an approach. This presentation will focus on the strategies required to enable single cycle cell line development.

16:45 - 17:15 30 mins
Cell Line Development and Engineering
Panel Discussion: Cell Line Manufacturability Assessment Strategies and Integration at the Interfaces
more
  • How to choose the best cell line for manufacturing in early screening?
  • Approaches to align workflows internally and improve the interface of USP and cell line development to select more adaptive clones
  • What type of cell line properties and performance criteria are required for bioprocessing?
  • Cell line and clone selection strategies for manufacturability
  • Integration of high throughput automation platforms to improve selection and screening
  • Evaluating how good small scale models are for modelling bioreactor conditions
  • Accurate clone screening and cell line selection using media formulations used in upstream processing
  • Methodologies for identifying product stability traits and product quality attributes for choosing cell line for manufacturing at early stages
17:15 - 17:20 5 mins
End of Cell Line Development and Engineering 2018