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Insightful, valuable, and detailed application notes from Solentim. Learn how our biopharmaceutical instruments have been used by customers for single cell seeding, clone screening and improved outgrowth and produce stable cell lines.
Development of a highly efficient, documented workflow for making clonal cell banks of gene-edited iPSCs
In this latest application note of the iPSC series, we have demonstrated the workflow for a single gene edit, including confirmation of correct sequence and maintenance of pluripotency prior to banking. As part of this process we also documented clonal origin which would be able to support an IND application.
Methodologies, utilised in CLD, include viable cell counting, confluency, single cell seeding, plate transfer and consolidation, titer assays and microscopy. It is central to this narrative that data from all these aspects are joined together in a single story of a cell’s journey through this process.
VIPS (Verified In-Situ Plate Seeding) is the high efficiency single cell seeder designed to accelerate single-cell cloning workflows. Over the last year we have incorporated a number of updates to VIPS to improve the efficiency of single-cell seeding.
From cell seeding through assurance to clone selection, quality data wrapped up in a single data management system
Decision making at each step in a CLD process requires information derived from different technologies, traditionally disparate. Understanding and managing the quality of this data and following the data about each cell’s journey through the project is challenging.
Emergent cell therapy companies have an eye on the future production of clinical treatments. Whatever the timescale, the question of when and how to implement practices that will be scalable to cGMP (current Good Manufacturing Practice) often arise.
Scientists and Quality Managers working in the clinical manufacturing of therapeutics will be familiar with the Part 11 regulations. These describe the requirements for computer systems and digital signatures within cGMP regulated pharmaceutical environments.
Confluency, the percent area of a microplate well visually covered by cells, is used in cell biology as a trigger for key events including initiation of cell-based assays, transfection and passaging.
Standardizing the process for viable, high efficiency single cell cloning of hiPSCs whilst maintaining stem cell pluripotency.
Optimising seeding efficiency and colony outgrowth of iPSCs with the VIPS and a new soluble matrix called MatriClone™.
Development of commercial manufacturing cell lines by screening less than 200 clones using a combination of ATUM's Leap-In transposases with the VIPS and Cell Metric from Solentim.
A thorough review of potential clone screening workflow approaches to cloning method qualification and quality control using the fluorescence Cell Metric application.
The Cell Metric imaging platform enables clone outgrowth to be monitored using confluence after single cell seeding, as well as monitoring colony formation as part of a clone screening and selection process, thereby optimising workflows. Read more about how the Cell Metric could streamline your cell line development processes.
The Cell Metric can greatly improve traditional practices of hybridoma colony identification and monitoring. Our cell imaging system enhances the discovery of new hybridoma clones whose novel sequences can be used as precursors to antibodies in stable cell line development or for diagnostic antibodies.
Using the Cell Metric® imaging platform, the clonal origin of colonies can be established during cell line development, providing a clear image of the cell and its subsequent growth for documentation. Find out more about how the Cell Metric can help you meet regulatory requirements.
In this presentation to BPI 2019, Celonic detail significantly improved timelines for CLD using a reduced number of cell plates, which enables delivery of more projects per year with assured clonality.