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Customer Success Story: Why Clean Cells Chose VIPS PRO: The Need for Clonality & GMP Compatibility
We recently sat down with one of our valued customers, Dr Alexis Rossignol (Clean Cells), to discuss his experience with VIPS PRO, our cutting-edge technology designed to streamline and enhance the early stages of cell line development.
This interview provides insight into Clean Cells’ quest to automate and increase single-cell seeding while having undisputable proof of clonality even in GMP settings.
Dr Alexis shares candid insights into the challenges his CLD team faced before implementing our solution, the integration process, and the tangible benefits they now enjoy.
Clean Cells is a GMP Certified CRO of 140 staff members. We provide quality controls for biotherapeutics, mainly in the field of biosafety, identity, purity, and potency assays. We also offer the production and associated characterization of Master and Working Cell Banks or virus seed stocks, used as starting materials for the production of additional biologics such as viral vectors, therapeutic recombinant proteins, antibodies, or vaccines.
All QC testing provided by Clean Cells are available under GMP grade (covered by a GMP certificate emitted by the French sanitary authorities). Our analytical methods are developed and validated in order to meet regulatory requirements. All our starting material production activity is also performed under GMP conditions.
We offer a single-cell isolation service to our customers, but to be compliant with the Regulations, the proof of monoclonality must be irrefutable. Getting a system performing both single-cell seeding and whole well images was the most challenging.
Before incorporating VIPS PRO, we were performing manual limiting dilution, but the process was laborious. We also did not have an imager for whole well imaging. Instead, we manually monitored the seeded plates and recorded the growth results (on paper).
It is the only instrument, to our knowledge, that combines single-cell seeding and whole-well imaging to provide proof of monoclonality.
The STUDIUS™ software is very intuitive and user-friendly. The images are of very good quality with the different focus planes. Overall, using the VIPS PRO is very intuitive.
The Advanced Instruments team is very proactive, dynamic and open-minded. They are very receptive to our remarks and feedback on the instrument and the software.
The training provided by the Field Application Scientist (FAS) was clear and instructive. We feel 100% supported by Advanced Instruments.
The aim of Clean Cells is to consolidate its role as an expert in the quality control of biological products in Europe and North America and to support our partners in the successful development of therapeutic solutions. Our flexibility and agility mean we can offer suitable solutions (compendial and rapid testing) to guarantee the safety of biological products.
In addition to clonal selection, we are currently implementing and developing Next-Gen Sequencing services to address the identity and viral safety of biological products. We also want to offer analytical alternatives to speed up quality control release of ATMPs (mycoplasma detection, viral safety, etc.).
Our sales team and experts are available to discuss the needs of our partners. Don’t hesitate to contact François Pedelaborde (Head of Sales) fpedelaborde@clean-cells.com or get in touch with us using our contact form: https://clean-cells.com/contact-form/
Alexis Rossignol defended his Ph.D. in 2007 on the theme of anti-tumor immunology at the University of Poitiers. He then joined Hervé Watier’s team in Tours to develop in vitro cell-based assays exploring the functional activity of therapeutic antibodies. He joined Clean Cells in 2011 where he is in charge of the development and validation of potency assays measuring the biological activity of antibodies (potency assays). He is also an expert in cell biology methods and in the single cell isolation platform VIPS PRO at Clean Cells.
Alexis Rossignol Ph.D.
Analytical Development and Validation Project Manager at Clean Cells
