Exploring the Possibilities of iPSCs: Expert Interview on Advancements in Cell Therapy Research and Development
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Nicola Bevan knows a lot about complex cell models and what they need. As a manager in the BioAnalytics applications group at Sartorius, she leads a team focused on developing new applications for both traditional and emerging research areas. In our chat, she talks about iPSC-based cell therapies and the common challenges researchers encounter in their work.?
What’s the big deal with iPSCs?
Induced pluripotent stem cells, or iPSCs, have sparked a wave of breakthroughs in regenerative medicine and cell therapy. These cells can turn into any cell type in the human body, offering huge potential for treating a wide range of medical conditions without the ethical concerns tied to embryonic stem cells.?
One of the coolest things about iPSCs is that they can be reprogrammed from a patient's own cells. This is key to personalized cell therapy because it lowers the risk of the body rejecting the treatment. But while iPSCs have a lot of promise, they come with challenges. Growing these cells can be pricey, and keeping them in their pluripotent state requires very specific conditions.??
Check out our full interview with Nicola about using these cells in developing cell therapies.??
Question: Can you give a brief overview of the cell therapy development workflow???
Developing iPSCs is a complex, multi-step process. First, you need to isolate and grow the primary cell type. Then, the cells are reprogrammed to become pluripotent, and the best clones are picked. At this point, gene editing might be used to give the cells the right compatibility traits.?
Next, the cells go through more selection and expansion to create master and working cell banks, with constant checks to make sure they stay pluripotent.?
After that, you need to trigger differentiation, guiding the cells to become the specific type needed for therapy. This part takes time and involves a lot of technical steps and checks to make sure the cells have the right characteristics.??
The last step is to scale up the system to produce a sterile, functional product in enough quantities for clinical use
Question: What are the biggest roadblocks when it comes to developing iPSCs???
iPSCs need careful handling and constant monitoring to keep their pluripotency, viability, and consistency. Over time, they can change in both genotype and phenotype, even within cell lines from the same source. So, it's important to have ways to keep an eye on them and reduce variability in iPSC lines.??
As stem cells become more common in clinics and research, there's a big need for fast, reliable, and cost-effective methods to grow, characterize, and maintain these valuable cells.?
Question: What are some tips for successful iPSC-derived cell therapy process development??
It's crucial to keep tight control over the whole development process. This means thorough screening at every stage, tweaking each step to get a consistent and sterile final product, and setting up a scalable production line.?
Automating as many steps as possible is key to reducing variability and boosting production capacity. Quick optimization of the process with screening systems is essential, especially for scaling up. Plus, there needs to be a system for ongoing characterization of iPSCs and their derivatives throughout differentiation.?
Finally, tracking critical process parameters (CPPs) and critical quality attributes (CQAs) is vital for assessing your process's effectiveness and ensuring a smooth transition to larger-scale production.?
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Question: What tools and technologies do you use to overcome these challenges???
The best solutions should help you fine-tune differentiation protocols, speed up process development, and consistently produce high-quality outputs.?
In the research and development phase, the Incucyte? Live Cell Analysis and iQue? High-Throughput Screening (HTS) by Cytometry platforms are great for quickly and accurately characterizing cell phenotype and function, meeting industry standards. For quickly isolating single iPSC clones, the CellCelector platform is very versatile and reliable.?
High-quality cell culture products and lab essentials are key for successfully and sterily growing iPSCs. Our research-use-only (RUO) growth factors and cytokines support the proliferation and differentiation of iPSCs, while our GMP-grade growth factors and cytokines ensure a smooth transition from research and development to pre-clinical stages and GMP-compliant manufacturing.?
Fast and dependable microbial detection kits also play an important role in keeping contamination under control throughout the entire process.?
Question: If you could give one tip for simplifying the development of iPSC-derived cell therapies, what would it be???
If I were to offer a single piece of advice for streamlining the creation of iPSC-derived cell therapies, it would be to embrace automation. Automated systems can greatly reduce manual work, leading to products that are safer and more consistent.?
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Experimental Medicine , Faculty of Medicine, UBC, Vancouver | Medical Content Writing
3 个月"Which regulatory hurdles have you found most daunting in advancing cell therapy innovation within the R&D landscape?" https://lnkd.in/g5mtXxGe