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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Technology innovation through adaptive and customized cell culture automation

July 8, 2022

As biotherapeutics development using mammalian cell platforms continues to grow, continuous improvement and optimization of cell line development processes are crucial. Selexis’ cell line development platform requires routine passaging of hundreds of suspension-adapted cell lines. Traditionally, such cell passaging workflow is performed in Erlenmeyer flask and spin-tube, several times a week and requires high quality and process consistency, susceptible to human variability and errors. Yet, such capped labware remains difficult to automate culture formats.

In the context of increasing demand for biotherapeutics development and in an effort to improve cell culture processes, we have imagined and developed customized and flexible solutions for a fully automated seed train incubation and passaging process, without manual intervention and controlled by user-friendly and easily accessible process control software. At the limit between lab automation and industrial robotization, we have automated an existing shaker incubator, well-known in the biotechnology industry. The design of such customized equipment enables special labware handling and transportation from the incubator compartment towards a high-performance automated liquid handling instrument. For such an application, a special Erlenmeyer flask holder and customized decapping-recapping system were designed. This automated seed train passaging platform also involves best-in-class robotized arms, automated hotels, incubators, and centrifuge. As part of a comprehensive and innovative automation process, we have implemented last-generation PAT tools and technology enabling online cell counting.

All components and devices from different suppliers are functionally joined and integrated into a central control system enabling a flexible process scheduling to perform the tasks. Implementing such automated and customized cell culture processes will improve operational efficiency. Repetitive cell cultivation tasks will be completed faster while decreasing resources will still allow increasing throughput.

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