Scientific Poster

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Rapid assessment of Aggregation of Biologics in Different Matrices and from Upstream and Downstream Development Process Stages

July 20, 2022

Assessing and controlling aggregation of biologics is vital to ensure the safety and efficacy of a biopharmaceutical product. In addition, aggregation has been recognized as a major issue for modern therapeutic modalities such as bispecific antibodies and Fc fusion proteins. Therefore, checking for aggregation propensity is an essential part of developability assessments throughout the development cycle, starting from in silico approaches in the protein design phase to experimental confirmation and analysis in the discovery and upstream and downstream development stages.

In these stages, hundreds of samples need to be analyzed. These numbers pose a big challenge for current analytical approaches (mainly size exclusion chromatography, SEC), which are slow and require sample purification. We have addressed this bottleneck by developing a high throughput aggregation screening assay that allows the assessment of aggregation of molecules containing the antibody Fc domain in different sample matrices and cell culture supernatants. This is the first assay capable of screening hundreds of samples within two hours and without purification of samples. We are presenting different data sets from forced aggregation studies and data from Biopharma development partners.

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Keywords: research cell bank Recombinant protein production next-generation sequencing genomic analysis
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Whole Genome Sequencing to Survey Genetic Changes in Stable CHO Cell Lines

May 14, 2017

Chinese hamster ovary (CHO) cells represent the most frequently applied host cell system for industrial manufacturing of recombinant protein therapeutics. Generating and identifying high producing clones in a fast and efficient way such that they do not lose their expression capability over time has been a major focus of the industry.

Using cytogentic analysis combined with next-generation sequencing technology and proprietary bioinformatic tools called SUREscan, provide us with a unique ability to quickly analyze the whole genome of any generated cell line. Our data show that phenotypic changes in growth behavior and metabolism typically cuased by cellular stress such as adaptation to a different media are associated with a rise in single nucleotide polymorphisms (SNPs). However, karyotype analysis of a large number of research cell banks (RCBs) revealed our CHO lineage is chromosomally  stable indicating that the critical stages of a call line production platform do not induce chromosomalchanges. This contrasts with previous studies that have sown large chromosomal rearrangements in CHO cell lines.

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Keywords: research cell bank CHO Chinese hamster ovary next-generation sequencing SUREscan recombinant protein whole genome sequencing single nucleotide polymorphisms chromosomal rearrangements
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SELEXIS SUREscan: De-risking Cell Bank Generation with Comprehensive Genomic Analysis

September 29, 2015

Recombinant therapeutic protein production processes must guarantee a sufficiently small variability in the product quality. To keep this variability low, it is critical to run the process in a totally reproducible way. This requires controlling all cultivation parameters. The use of new analyzers, generating new data sets, besides cultivation parameters (e.g. viable cell density, metabolite concentrations) is a desirable way to innovate bioprocesses. The advent of Next-generation Sequencing (NGS) has led to the ability of using genome information to find reasons for variability. Research Cell Banks (RCBs) are not necessarily cell populations with identical genomes or single integration sites even though they arise from a single isolated cell. These mixed populations can lead to unacceptable manufacturing variability. Selexis’ SUREscan™, consisting of the detailed CHO-M genomic map and proprietary bioinformatics tools, decreases manufacturing risks by ensuring transgene integrity in RCBs and by surveying for the emergence of deleterious mutations either in the transgene sequence or in genes that are important for cell survival at a yet unknown resolution.

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Keywords: research cell bank Recombinant protein production next-generation sequencing genomic analysis