Webinars

Streamlined Development for Efficient Production of Bispecific Molecules Using an Integrated Platform Process

June 2022

Séverine Fagète, PhD, Vice President Cell Line Services

There is a global need for high quality, effective off-the-shelf therapies that can be used immediately, while concurrently avoiding supply chain issues and mitigating process complexities. Bispecific antibodies (bsAbs) are constructed to help meet this need due to their ability to bind to two or more different epitopes, thereby allowing them to perform multiple discrete mechanisms of action.

This webinar will demonstrate a breakthrough platform approach that encompasses the efficient production of bispecific molecules in an integrated, streamlined way, from CLD (cell line development) to cGMP manufacturing. The leverageable integrated workflow from Selexis and KBI Biopharma generates high quality clinical bulk drug substances under accelerated timelines.

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Keywords: #difficulttoexpress #biotherapeutics#GMP#CLD#bispecifics#onestopshop#CDMO

Exploring the limits of conventional small scale CHO fed batch for accelerated on-demand monoclonal antibody production

May 2022

Séverine Fagète, PhD, Vice President Cell Line Services

In the field of therapeutic antibody production, diversification of fed-batch strategies is flourishing in response to the market demand. All manufacturing approaches tend to follow the generally accepted dogma of increasing titer since it directly increases manufacturing output. While titer is influenced by the biomass (expressed as IVCD), the culture time and the cell specific productivity (qP), we changed independently each of these parameters to tune our process strategy towards adapted solutions to individual manufacturing needs. To do so, we worked separately on the increase of the IVCD as high seeding fed-batch capacity. Yet, as intensified fed-batch may not always be possible due to limited facility operational mode, we also separately increased the qP with the addition of specific media additives. Both strategies improved titer by 100% in 14 days relative to the standard fed-batch process with moderate and acceptable changes in product quality attributes. Since intensified fed-batch could rival the cell-specific productivity of a conventional fed-batch, we developed novel hybrid strategies to either allow for acceptable seeding densities without compromising productivity, or alternatively, to push the productivity the furthest in order to reduce timelines.

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Keywords: #titers #proteins#CLD#CHO#antibody#BPIEurope

SUREtechnology Platform to Overcome Phenotypic and Genetic Changes in CHO Cells

January 2022

Pierre-Alain Girod, PhD, Chief Science Officer

CHO cell volumetric productivity has significantly increased in the past two decades. However, turning these cells into high-producing factories has created an overall metabolic burden. In response to transgene expression pressure, CHO cells undergo phenotypic and genetic changes for continuous improvement. Selexis’ SUREtechnology Platform™ provides a solution for overcoming the challenges of high productivity tied to metabolic adaptability.

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Keywords: #suretechnology#cho

Comprehensive Cell Line Characterization and Genotypic Stability

May 2021

Emmanuel S-Siegert, PhD, Head of Discovery and Products

Sequencing of genomes has become an essential tool to study human/viral/microbial and cell-line diversity. CHO cell-line development benefits from these multi-modal sequencing advancements. We will present our solutions that assess comprehensively the genotypic stability of clones, the location and architecture of transgene integration and additionally the quality and risk associated with a clone selection.

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Keywords: #WGS#NGS#Bioinformatics

Selexis SUREtechnology Modular Approach for Expression of Diverse Array of Biomolecules

May 2021

Pierre-Alain Girod, PhD, Chief Science Officer

Technology platforms are integral to the design, development and commercialization of recombinant biotherapeutics. We developed a versatile platform - SUREtechnology – that facilitates the effective combination of polypeptides. It provides convenience to produce complex protein scaffolds including antibodies, bispecifics, viruses, Fc-fusions, cytokines, and vaccine antigens. By enabling a robust expression of transgenes and enhanced throughput it enables the combination with metabolism interfering proteins to ease the expression of difficult-to-express scaffolds.

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Keywords: #SUREtechnology #antibody#antibodyexpression#difficultoexpress

Harnessing Whole Genome Sequencing and FISH Analysis for Authentication of Monoclonality of CHO Cell Lines

January 2021

Pierre-Olivier Duroy, PhD, Director Emerging Technologies

Establishing monoclonality of research cell banks (RCB) and master cell banks (MCB) is critical for successful and cost-effective biologic manufacturing campaigns and regulatory filings. Using whole genome sequencing (WGS) and proprietary bioinformatics tools, Selexis is able to establish monoclonality through an unbiased approach that identifies and validates integration sites, establishes clonality using integration sites as markers and provide transgene sequence, copy number and integrity.

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Keywords: #WGS#NGS#Bioinformatics#FISH

Next-generation cell line development platform for advanced bispecific antibodies expression

June 2020

Séverine Fagète, PhD, Vice President Cell Line Services

Complex human diseases are being addressed with increasingly complex biomolecules such as bispecific antibodies, triabodies, Fc-fusions, cytokines and vaccine antigens. Cell line development (CLD) is the first critical path for manufacturing these novel therapeutics. The pressures on the Chinese hamster ovary (CHO) cell to produce these complex scaffolds led Selexis to develop modular approach to its technology platform. The SUREtechnology Platform (SUREtech) consists of modules that address a range of issues such as translation and secretion bottlenecks, lead candidate selection, quality assessment and, last but not least, unbiased clonality assurance using next-generation sequencing. SUREtech is based on codon optimized genes surrounded by epigenetic regulatory elements. By enabling a robust expression of transgenes, SUREtech enhances the expression of difficult-to-express scaffolds. At Selexis, we believe in the promise of these newer biologics and have committed significant resources to ensure our technologies can meet the new expression challenges that these non-natural proteins present. Because each drug is unique, we will present various case studies illustrating the benefit of a modular approach to generating high-yield production cell lines.

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Keywords: #CLD#Geneva#antibody#antibodyexpression #celllinedevelopment