Enhanced cell line development workflows for successful IND submissions
As the FDA approves 100th monoclonal antibody product we are reminded that therapeutic antibodies have become the predominant class of new drugs developed in recent years. Targets include many cancers, autoimmune, metabolic and infectious diseases including COVID-19. Cell line development (CLD) using CHO type cells is a key step in the discovery and development of new biological medicines and therapies including monoclonal antibodies.
Within the CLD environment there is a widely accepted regulatory expectation to demonstrate that a Master Cell Bank (MCB) has been derived from a single cell to best manage the quality of the biotherapeutic produced.
For Assurance And For Accelerated Workflows
Solentim’s unrivalled VIPS™ and Cell Metric® instruments work to provide high efficiency single cell seeding and to capture evidence and provide assurance of clonality.
And now with ICON™, the new instrument for productivity assessment, they work to accelerate the discovery and development of new biological therapies, enhance productivity and deliver efficiency and speed with the highest level of confidence.
In Solentim's new ecosystem structure, VIPS, Cell Metric and ICON data can be managed and viewed centrally through STUDIUS™. Learn more in this new blog article.
The Antibody Society. Therapeutic monoclonal antibodies approved or in review in the EU or US. (date accessed); www.antibodysociety.org
We accelerate cell line workflow timelines from upstream development through scale-up to production of new biological therapies. From vector design and host cell selection prior to transfection, single-cell cloning and colony outgrowth right through to the establishment of the Master Cell Bank, Solentim technologies provide the evidence for credible IND submissions.
Delivering Assurance in the Cell Line Development Process
Unparalleled regulatory assurance - The clonality report automatically captures the CLD process, from single-cell to colony, within the context of a whole well image.
Faster project delivery - Smarter technologies ensure higher efficiencies for fewer plates per project.
Proven technologies - For over 10 years, we’ve developed and sold CLD technology to the leading biopharma companies worldwide, validated and backed by ISO 9001.
Fast customer site implementation - Most customers achieve full technology implementation within two-three months of installation.
Simple operation - Our instruments are designed for effective use by all team members, enabling workflows to be replicated across multiple sites.
Quality service - Our robust instruments and reagent products are supported at a global level.
Technologies for Cell Line Development
Stable pool creation Leap-In Transposase®
With demonstrated IND submission success, stable, multiple-copy vector integration in transcriptionally active areas. Substantial reduction in the number of wells needed to achieve the target number of high expressing clones.
VIPS for high efficiency single cell seeding and in-well verification by imaging
Very low-pressure seeding with high-efficiency plating leads to confidence in clonally-derived outgrowth. Cell imaging of the VIPS droplet in the dry well gives evidence of successful single-cell isolation.
Cell Metric for Day 0 single cell assurance and outgrowth imaging
Whole-well, high-contrast imaging of the media-filled well to confirm the presence of a single-cell at day 0. Daily imaging to follow outgrowth with data wrapped up in clonality report for confident IND submission.
ICON for characterization of high productivity clones in cell line development
Rapid assays for the three critical quality attributes of titer, cell number and cell viability enable rapid stratification of leading candidates. Winner of the SLAS New Product Award, ICON slashes timelines and enhances success through meaningful data.
STUDIUS for dynamic data sorting on the journey of each individual cell
High quality, well managed data drives good decision making in cell line development. STUDIUS gathers, analyses and stores data securely to accelerate workflows.
InstiGRO™ and InstiSHAKE™Cell Growth Supplements
InstiGRO CHO for higher chance of single cell recovery and faster, high-efficiency clonal outgrowth for compressed workflows. InstiSHAKE for increased growth rates and viability when expanding from static to fed-batch shaking culture.
More about the Cell Growth Supplements>
Leap-In Transposase® is a trademark of ATUM®
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Cell line development (CLD) for biologics
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