The Need for Improved Single Cell Cloning of hiPSCs
Human induced pluripotent stem cells (hiPSCs) have practically unlimited proliferation potential and a capability to differentiate into any cell type in the human body. Such is their power, hiPSCs have become a major focus in nearly all disease areas and a vehicle for future therapeutic especially when combined with gene editing technologies.
Current workflows including colony picking, FACS and limiting dilution and use matrices which required plate-coating. These approaches are frequently time-consuming and demonstrate low efficiency often with uncontrolled levels of reproducibility and single cell assurance.
VIPS™ has been widely accepted for workflows using CHO and HEK cell lines as a high efficiency single cell cloning platform and provider of high-quality evidence of clonality.
Due to their inherent nature, iPSC single cell cloning presents challenges to the stem cell community leading many to use time consuming manual seeding methods and inconsistent coating-plating plates protocols.
Solentim has introduced a novel and robust workflow for the single cell cloning of hiPSCs using the VIPS in combination with a new soluble dispensing matrix called MatriClone™.
VIPS offers high efficiency seeding of high viability cells and dispenses MatriClone as part of the seeding process. MatriClone is a defined animal component-free matrix and facilitates cell attachment and growth without the need for pre-coating culture plates. MatriClone’s optical qualities is perfectly suited to enable VIPS to capture high quality evidence of clonality.
Enhanced Outgrowth and Cloning Efficiencies
There is a widely accepted regulatory expectation to use single cell cloning within hiPSC workflows.
VIPS is uniquely capable of performing the functions of high efficiency single cell seeding, capture of single cell evidence immediately post seeding and daily whole well imaging to record evidence of clonal outgrowth.
This data is packaged in a clonality report ready for inclusion in a Regulatory package.
The new VIPS + MatriClone workflow crucially maintains pluripotency across multiple passages and shows a 4-5 fold improvement over existing methods.
This new method is fast and easy to use.
Dispensing consumables are supplied sterile and can be assigned to individual projects inviting solutions in the areas of cellular reprogramming, gene-editing and allogenic production.
Supporting Future Manufacturing of Stem Cell Therapies
It is essential for all customers who are developing stem cell therapies that they can procure from companies who can supply products that fully integrate into their cGMP regulated environment.
Solentim is committed to supporting our customers compliance to the recognised world-class, global standards of cGMP with the implementation of GAMP-5, FDA 21 CFR part 11 and Eudralex Volume 4 Annex 11 requirements. Solentim has policies in place that comply with these standards.
"Establishing New Standards in Efficient Single Cell Cloning of hiPSCs"
EverCell Bio is a single-source provider of customized services for the application of stem cell technology in cell therapy. EverCell offers human cell-modelling capabilities, such as donor cell line establishment, reprogramming, gene-editing and differentiation. When the decision was made to improve its iPSC workflows, EverCell chose Solentim’s Verified In-Situ Plate Seeding (VIPS™) solution for its single cell cloning capacity, image-based evidence of clonality and ‘double lock’ for regulatory submission. Philip Manos, President at EverCell, spoke to Emma Pickup, from Sciad Communications to explain why.