Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer ground breaking new opportunities for the treatment of disease and injury. 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.
hiPSC cells are a source of potential cellular immunotherapies including TCR-T cells, CAR-T and NK/NKT cells. This allogenic approach bypasses the need for patient cells, offers significant reduction in per-patient costs and offers a route to enhanced standardization of practice.
In the commercial setting, hiPSC Master Cell Banks must be produced under cGMP conditions and utilise the practice of single cell cloning, familiar to other high value cell scenarios.
Current workflows are time consuming and present challenges to auditing and quality control. Post gene editing and nucleofection, a common workflow would utilise dilution cloning into 10cm Petri dishes followed by picking and multiple expansion steps. Projects can take between 60 and 90 days and ultimately do not produce quality evidence of clonality rather pointing towards statistical calculations.
The new workflow from Solentim utilises the high efficiency seeder VIPS™, Cell Metric® and the imaging ready MatriClone™. VIPS has been widely accepted in therapeutic antibody workflows enabling high seeding and outgrowth efficiencies and a ‘double lock’ of assurance. Cell Metric offers daily plate imaging. MatriClone is a soluble dispensing matrix which pre-mixed with media with the plate wells automatically filled by VIPS immediately after seeding.
This new workflow takes only 30 days and results in a Clonality Report for use as part of an IND.
VIPS and MatriClone Application Note
In this application notes, learn how VIPS + MatriClone workflow leads to a 4-5 fold improvement in the number of clonal colonies over existing methods.
Maintenance of pluripotency Application Note
In this application note, discover how the process of single cell seeding on the VIPS does not change the phenotype of the cells or cause any differentiation to occur.
Supporting Future Manufacturing of Stem Cell Therapies
Customers developing stem cell therapies need to procure from companies who can integrate into their future cGMP regulated environment.
- Clinical manufacturing-grade laminin matrix is now available, for use in combination with the VIPS and Cell Metric instrumentation (more information available on request). Establish cell therapy workflows during process development using MatriClone together with VIPS, and then progress onto clinical manufacturing using Clinical manufacturing-grade laminin matrix.
- 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.
- The Clonality Report documenting the history of the clone from the colony all the way back to the single cell is also a vital component of any future IND submission.
- 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.
"A New Platform for Clinical Gene Editing of iPSCs to Make Clonal Cell Banks"
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.