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Platform Overview

The Ncardia iPSC Platform utilizes human iPSC to manufacture differentiated cells at scale and employ targeted assays to characterize and test from identity to functionality.

The Platform is employed in Drug Discovery and Cell Therapy. In both segments we start with human iPSC to manufacture the cell of interest. In Drug Discovery, we develop assays to compound effects compatible with high-throughput screening technologies. This includes target discovery & validation, primary or secondary screening, Hit-to-Lead optimization and pre-clinical development.

For Cell Therapy projects, the Platform is equally suited to yield the required functionality, potency and safety data. Each project is led by the appropriate scientific domain experts in cardiovascular, neuroscience and immunology, as well as process development and manufacturing scientists.

iPSC Sourcing & Reprogramming

Ncardia assists clients in securing iPSC lines from healthy and patient donors. Integrated into the Platform is access to a menu of sourcing options including access to Ncardia’s in-house, qualified healthy and disease hiPSC lines or sourcing of healthy and disease hiPSC lines through established relationships with leading medical centers and consortiums. Appropriate ethical approvals, consents, and contracts are in place such that hiPSC lines from a wide variety of genetic diseases can be acquired on demand.

Sourcing of patient-derived material is then followed by in-house reprogramming when requested.

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Differentiation to Cell Model

Direction of iPSC differentiation into nearly any cell type in the human body is now possible. Stem cell characteristics and differentiation are influenced by the culture conditions, as defined by the medium composition, physiochemical environment, physical forces, cell-cell and cell-matrix interactions, and others.

Building on our track record of differentiating and commercializing more than 10 different cell types, we routinely expand our reach into additional lineages through internal innovations and in the service of client projects. We develop differentiation protocols by design or utilizing Ncardia IP assets to generate requested cell types. Differentiated cells are fully characterized for lineage marker expression by RNA and protein analysis. We specialize in building processes from laboratory protocols into differentiation procedures that are robust and ready to scale. This includes reducing handling steps, establishing xeno-free conditions and closing processes when needed.

Process Development & Scale-Up

Cell models originating from early research protocols can struggle to reach the larger quantities and stricter quality required for commercial application or pre-clinical studies and high-throughput screens. Transfer of manufacturing protocols from developmental phase to large-scale production often requires optimization to reach the required quantity and quality. We have successfully transitioned processes in culture plates or flasks by scaling out the number of culture vessels. Stirred-tank bioreactors have also been utilized to scale up yields in excess of 20 billion cells per batch for certain cell models. Cultivation in bioreactors includes process monitoring and control, including pH, temperature, and DO, among other parameters, optimized and monitored in real time.

Assay Development, Disease Modeling & Screening

We bring together proven cell models and expertise in cardiovascular, neurological and immune cell biology with all key technologies in disease modeling and drug testing to develop and implement assays for Drug Discovery and Cell Therapy. Our Platform is routinely utilized in projects to validate a target through phenotype rescue. phenotypic screening to identify a molecule that reverses a disease phenotype, and establishing SAR to measure potency and safety of compounds. In terms of disease modeling, we utilize a variety of in-house disease modeling capabilities including chemical induction of disease phenotypes and physiologically relevant co-cultures to mimic human biology, for instance co-culture of microglia or with neurons. These capabilities are supported by a large panel of assay technologies, including high content screening, metabolism, calcium transients, gene expression, and electrophysiology.

The Ncardia iPSC Platform for Drug Discovery and Cell Therapy

Building better cell models and assays at scale to make the implementation of stem cell technology in Drug Discovery and Cell Therapy possible.

 

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