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Key Sessions

Thomas Kelly

Use of the Cyto-Mine for Rapid Generation of Clonal Cell Lines

Janssen R&D, Inc.

Conrad Vink

Rapid Generation of High Titre Stable Producer Cell Lines for Lentiviral Vector Manufacture


Apr 23
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08:15 - 09:00 45 mins
Registration and Morning Coffee
09:00 - 09:10 10 mins
Chairperson's Opening Remarks
09:10 - 09:50 40 mins
Cell Line Development and Engineering
Monoclonality Assessment of Existing Production Cell Lines
  • Martin Bertschinger - Deputy Director Cell Sciences, Glenmark Pharmaceuticals SA.

It is a regulatory requirement (ICH Q5D) that cells used for the production of therapeutic antibodies have to be clonal, i.e. derived from a single cell progenitor. The FDA has recently provided guidance on acceptable procedures for the generation of clonal cell populations (e.g. two subsequent rounds of limiting dilution). In case cell lines were generated using a process not fully compliant with the procedures suggested by the FDA, additional data need to be generated. Glenmark has developed a method using the statistical analysis of presence and absence of specific genetic features in a population of sub-clones to assess the monoclonality status of a cell population. The method can be applied to existing cell lines with unknown monoclonality status and may allow to avoid changing the production clone or adapting the control strategy (if no secondary population can be detected).

09:50 - 10:30 40 mins
Cell Line Development and Engineering
Use of the Cyto-Mine for Rapid Generation of Clonal Cell Lines
  • Thomas Kelly - Scientist, Janssen R&D, Inc.

The Cyto-Mine is a microfluidic instrument designed for encapsulating single-cells in picodroplets and FRET-based productivity screening in a single-use cartridge. We have tested this instrument and method with mAb and non-mAb projects and found it can generate cell lines with high productivity, high viability, and a high assurance of clonality after a single round of screening, all in shorter timelines.

10:30 - 11:00 30 mins
Cell Line Development and Engineering
HT-NIC, a Novel High-Throughput Nanowell-Based Image-Verified Cloning Platform for Fast Generation of Clonal Production Cell Lines with Integrated Monoclonality Proof
  • Volker Sandig - Chief Scientific Officer, ProBioGen GmbH

Along with productivity, PTMs, process robustness and expression stability proven clonality is key for pharmaceutical cell line development. Automated Lab Solutions (ALS) has developed a novel technique to reliably image individual cells and automatically select and isolate resulting colonies from liquid medium based on its automated cell picking platform ALS CellCelector. The approach provides unique in-process validation of clonality and allows parallel assessment of growth and productivity for thousands of colonies. We will demonstrate its performance within cell line development workflow with single cloning round.

11:00 - 11:30 30 mins
Cell Line Development and Engineering
Morning Coffee and Networking
11:30 - 12:10 40 mins
Cell Line Development and Engineering
NGS-Mediated Analysis of Cell Line Monoclonality
  • Nicolas Mermod - Director of Institute of Biotechnology, University of Lausanne

Cellular whole genome analysis by NGS can be used to assess the genomic integration locus of the transgenes, as well as the propagation of single-nucleotide variants that result from genome-wide mutations. This presentation will illustrate how this can be used to assess the monoclonal origin of CHO cell populations, and how this can reliably detect even minor population contaminants in non-clonal populations.

12:10 - 12:30 20 mins
Cell Line Development and Engineering
Shifting The CMC Outsourcing Paradigm For Small Biotechs In The Competitive Immuno-Oncology Field By Establishing Robust Cell Line Development Capabilities
  • Alessandro Mora - Senior Scientist, Cell Line Development, CMC, Jounce Therapeutics

Timely generation of good quality CHO cell lines that can be seamlessly transferred to a CDMO is a key activity during IND-enabling studies for an immuno-oncology candidate. In this talk, we describe the selection process for in-licensing a CLD technology, optimization of CLD platform, and development of cell lines for model molecules. The host cell line, vector configuration, medium and utilization of a scale-down model are all factors in expediting development timelines.

12:30 - 12:50 20 mins
Cell Line Development and Engineering
Philogen’s Platform for the Development of Immunocytokines
  • Mattia Matasci - Head Cell Line Development, Philochem AG, Philogen Group
  • The presentation will focus on Philogen’s strategies for the development and manufacturing of antibody-cytokine fusion proteins (immunocytokines)
  • Overview of immumocytokines engineering, quality evaluation and manufacturability assessment
  • Description of Philogen’s cell line development platform
  • Examples of immunocytokines under preclinical and clinical development
12:50 - 13:20 30 mins
Cell Line Development and Engineering
Dispensing a Single Cell per Well with High Viability and Image-Based Documentation
  • Jonas Schoendube - CEO, cytena GmbH

cytena’s single-cell printer uses an imaging system and object recognition algorithms to detect cells in a single-use dispenser cartridge. Droplets are produced similar to inkjet printing. Cells are classified in the nozzle and subsequently dispensed directly into well plates. Image sequences of the printing process enabling assurance of clonality. High viability has been observed for several cell lines (CHO: >85 %; HEK: >90 %; L292: >80 %) and furthermore customer data will be presented.

13:20 - 14:30 70 mins
Cell Line Development and Engineering
Lunch and Networking
14:30 - 14:50 20 mins
Cell Line Development and Engineering
Cell Line Development Strategies for Bispecifics
  • Claire Harris - Scientist, MedImmune
14:50 - 15:10 20 mins
Cell Line Development and Engineering
Cell Line Development for Expression of Bispecific DART® and Trispecific TRIDENT™ Molecules
  • Valentina Ciccarone - Principal Scientist, Cell Line Development, MacroGenics, Inc.

DART and TRIDENT molecules have been designed to achieve multiple mechanisms of action and clinical applications.  They are composed of two to four peptide chains which need to assemble correctly for functional activity. The appropriate expression of each component by the production cell line is important in achieving high expression levels and product quality in order to successfully manufacture the clinical product.  By incorporating molecule engineering strategies, optimizing vector selection, and cell line screening, we have been able to achieve correct molecule assembly, high expression levels, and biological activity of these complex, multi-chain molecules. 

15:10 - 15:50 40 mins
Cell Line Development and Engineering
Rapid Generation of High Titre Stable Producer Cell Lines for Lentiviral Vector Manufacture
  • Conrad Vink - Manager, Vector Development, Cell & Gene Therapy, GSK

Lentiviral vectors are showing success in the clinic but large scale manufacturing remains a significant bottleneck to delivering these vectors to patients. Current manufacturing approaches are largely based on transient transfection of plasmid DNA into adherent HEK293T cells. This approach is expensive and challenging to scale beyond 10s of litres of harvested medium. This talk will present GSK’s alternative approach to lentiviral vector manufacturing based on cell line development of high titre stable suspension clones.

15:50 - 16:20 30 mins
Afternoon Coffee Break
16:20 - 16:30 10 mins
End of Conference Day One