This project is no longer accepting applications. Subscribe to our newsletter to be notified of new projects!
Exploring stem cell therapy with a focus on bioreactors and bioassays used for developing a scalable cell differentiation process.
Cell therapy refers to the transplantation of autologous or allogeneic cells into patients to treat diseases or repair damaged tissues. However, the gap between research-scale proof of concept and clinical patient doses is significant and multifaceted. This build project aims to explore key aspects of bridging the gap between R&D and clinical application in stem cell therapy, focusing on scalable/automated cell differentiation process development and cell-based analytical techniques.
You will delve into various types of bioreactors and close-system cell processing instruments, get exposed to different analytical techniques for cell phenotyping and drug efficacy assessment, and conduct an experimental proposal using the design of experiment (DoE) concept. The project will also introduce the drug commercialization process from the perspective of CMC (chemistry, manufacturing, controls) team. You will draft master batch records and raw material risk assessments, documents required for ensuring the drug consistent productivity and quality. This comprehensive project will equip you with practical skills in designing and scaling-up cell differentiation processes, applying advanced cell-based analytical techniques, and preparing documents related to therapeutics safety and regulatory compliance.
Provide an overview of the project and introduce cell therapy and its techniques and applications.
Introduce process of driving a drug product from research to market.
Understand the role and key aspects of process development in bringing a drug to market.
Dive into scalable cell differentiation process development and explore various types of bioreactors and cell-processing instruments.
Deepen understanding of different bioassays used for characterization of cell function and assessment of drug efficacy and safety.
Comprehend the principles and concepts of DoE and how to generate structured experimental designs.
Prepare the documentation required to bridge the gap between small-scale process development and large-scale production and regulatory compliance.
Integrate knowledge and skills in cell therapy and discuss learnings.
Get access to all of our Build projects, including this one, by creating your Build account!
Get started by submitting your application.
We'll notify you when projects reopen. In the meantime, you can explore our resources and learn more about our Fellows.