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Expert Insights: Large-scale manufacture of iPSC models

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By Mariana Argenziano, PhD

Making iPSC models available at large scale for drug discovery

Tessa de KorteMariana Argenziano, PhD
Senior Scientist Stem Cell Biology
Expert Profile

Mariana Argenziano holds a PhD in molecular biology from the University of San Martin (Buenos Aires) and has worked at several universities in the US for more than seven years. Throughout her experience in academical research, she gained great knowledge and expertise in the differentiation of iPSCs into cardiac and neuronal cell types, disease modeling and biobank building. In 2022, Mariana joined Ncardia as senior scientist in stem cell biology and is daily working on establishing new iPSC manufacturing procedures and scale-up to make them available for drug discovery.

Insights

Mariana describes how scaling up the manufacturing of induced pluripotent stem cells (iPSCs) is essential to make iPSC-derived models applicable for drug discovery. iPSC technology provides an unlimited source of cells that can be cryopreserved and used at different times, over a long period. However, the technical knowledge and capabilities required to produce large-enough amounts of cells, in a consistent manner, are significant.

“One of the reasons why I joined Ncardia is because of the incredible scientific and technical knowledge the company has accumulated for their iPSC manufacturing service over the years. I like keeping a transparent and fluid communication with clients, to understand their particular requirements, and seeing how they trust us to design the procedure that will lead to their ideal end-product in the shortest possible timeframe.”

Dr. Argenziano and the scientific team at Ncardia are often designing and optimizing new procedures with the end-goal of scaling up in mind, which gives them the experience to implement risk-mitigation strategies from the beginning. The team facilitates smooth transition between platforms and fast decision-making with pre-defined go/no-go criteria, to establish a highly efficient process. In addition, the incorporation of high-quality company standards ensures the manufacturing of robust and reproducible iPSC-derived models across time.

“Our clients in drug discovery are looking for high consistency in their screenings. If they come back to us, for example, a couple of years later, the model must meet the exact same criteria. A similar thing happens for regenerative medicine, where we deliver a huge number of cells every month, while keeping the same cellular profile and population characteristics.”

One of the biggest strengths of Ncardia, as Mariana explained, is that the company combines an excellent manufacturing service with high-quality efficacy and safety in vitro testing of new therapeutic modalities. The manufactured iPSC-derived models can immediately be used for a wide range of assays, such us functional, viability, metabolic or biomarker expression, at high-throughput. This enables therapeutic developers in early and preclinical drug discovery to get to crucial decision points faster and with higher confidence.

“Manufacturing and discovery services require flexibility to make data-driven decisions. The scientific teams at Ncardia are in constant communication and are located in the same facility. For instance, if the discovery team requires a higher number of cells, we can immediately adjust, and vice versa, with minimal impact in the overall timeline. This is a great advantage for our clients whose deadlines are usually tight.”

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