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Insightful, valuable, cell line development resources and commentary, including industry expert interviews, product brochures, case studies, application notes and more.
Higher Confidence of Clonality
February 2018: Here we review current cloning methods and levels of assurance and introduce our new VIPS single cell cloning system and its benefits.
Case Study Downloads
“Doubling the Speed of Cell Line Development in a Large Pharmaceutical Company”
Using Solentim’s VIPS technology, Janssen Pharmaceuticals has halved cell line development (CLD) workflow times whilst still meeting clonality requirements for regulators. Download the case study now to find out the many benefits of the VIPS System, including the combination with ATUM’s transposases, and to discover how this approach is revolutionising Janssen’s CLD workflow.
“Cutting Cell Line Development Timelines from 6 months to Less Than 13 weeks”
By transitioning to use a combination of Solentim’s VIPS and Cell Metric CLD products, as opposed to the previously used ClonePix (picking from semi-solid media) technology, Genmab significantly slashed workflow times. Learn more about the practical benefits that this has already delivered for the company and the motivations behind Genmab’s technology shift.
“Reducing the Timeline by 30% to Produce a Monoclonal Cell Line Expressing a Clinical Candidate Bi-Specific Antibody”
SystImmune’s chosen path forward to prove clonality was to introduce the Solentim Cell Metric CLD into their cell line development process. The Cell Metric can image the entire well and provide a sharp image of a single cell on Day 0 which is critical proof of a single cell and will allow for a single round of cloning.
Application Notes (downloads)
A thorough review of potential 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 here about how the Cell Metric could streamline your cell line development processes.
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.
The Cell Metric can greatly improve traditional practices of hybridoma colony identification and monitoring. Our imaging technology 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. Read more here.
Utilizing Cell Imaging Technology to Shorten Timelines and Reduce Development
Reducing cell line development timelines and resources is a key goal in the generation of bio-manufacturing cell lines. Download the Poster from SAFC
Proof that can travel – Documented clonality report for regulatory submission
Clonality is a key element of cell line development and is an important component of a regulatory submission.This poster shows an illustrative Clonality Report generated from raw data with a commercial CHO cell line, using Cell Metric CLD. Download the Poster from Solentim.
Assurance of Monoclonality of Recombinant CHO Cell Lines using High Resolution Imaging
This paper focuses on the main areas of investigation performed at FDM to integrate the Solentim Cell Metric into their CLD workflow; including the assessment of suitability of a range of 96 and 384 well microplates and animal component free medium types. Read more here.
Cell Metric CLD
Technology in action: Cell Metric CLD incubated plate loader and cassettes (courtesy of Horizon Discovery)
Regulatory Guidance on Clonality
Interviews with Former FDA CDER Reviewer, Dr Audrey Jia
For companies involved in cell line development for biotherapeutics, both interviews are valuable to watch
Episode 1: Regulatory Compliance and Best Practices in Cell Line Development
Episode 2: Importance and Utility of Dedicated Imaging in Cell Line Development
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