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Making a Cell Therapy: Principles and Practice of Manufacturing

Cell therapies, such as CAR-T and stem cell therapies, are an exciting new class of therapeutics with the potential to revolutionize medicine. Learn the biology, engineering, and analytical chemistry behind how these amazing new products are manufactured.

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9 semanas estimadas
5–7 horas por semana
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Sobre este curso

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The success of CAR-T cell therapies, driven by their unprecedented efficacy and recent regulatory approvals, has kick-started a new wave of interest into cells as therapies. Yet manufacturing is the link between an exciting new development in the laboratory and a commercial therapy available to the patients who need it. This course will introduce learners to this new field through the following topics.

  • Cellular therapies are living products that are only effective when delivered alive. This course will introduce the basic cellular biology that controls cellular growth and metabolism.
  • The enhanced function of some cell therapies relies on our ability to genetically engineer the cells. This course will teach the current and emerging approaches that are used for genetic modification.
  • This course will teach how we isolate cells from patients or donors and then manipulate them, including helping those cells to grow and multiply outside of the body, to produce a living product at a therapeutically relevant dose.
  • We also need to have confidence that the product we have made is safe and effective and that the process we have used to make it did not encounter any unanticipated obstacles along the way. This course will teach some of the analytical methods used to do this and why these methods were chosen.
  • As these are often individualized therapies, how do you reproducibly manufacture a highly complex living therapy for all of the patients who may need it? This course will teach about the unique characteristics of cell therapies and how those characteristics drive manufacturing, delivery, and supply chain decisions.
  • Cell therapies are part of the larger pharmaceutical industry, which operates under regulatory oversight. This course will teach about how drugs are regulated and how those regulations are applied specifically to cellular therapies.

This course is intended to provide an overview of the key concepts needed to manufacture a cell therapy for learners interested in entering this exciting new field.

Please note : edX Inc. has recently entered into an agreement to transfer the edX platform to 2U, Inc., which will continue to run the platform thereafter. The sale will not affect your course enrollment, course fees or change your course experience for this offering. It is possible that the closing of the sale and the transfer of the edX platform may be effectuated sometime in the Fall while this course is running. Please be aware that there could be changes to the edX platform Privacy Policy or Terms of Service after the closing of the sale. However, 2U has committed to preserving robust privacy of individual data for all learners who use the platform. For more information see the edX Help Center.

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  • Idioma: English
  • Transcripción de video: English

Lo que aprenderás

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  • cell biology and immunology
  • cell therapy manufacturing practices
  • analytics for cell therapy
  • industrialization of cell therapies
  • regulatory requirements for cell therapies

Acerca de los instructores

¿Quién puede hacer este curso?

Lamentablemente, las personas residentes en uno o más de los siguientes países o regiones no podrán registrarse para este curso: Irán, Cuba y la región de Crimea en Ucrania. Si bien edX consiguió licencias de la Oficina de Control de Activos Extranjeros de los EE. UU. (U.S. Office of Foreign Assets Control, OFAC) para ofrecer nuestros cursos a personas en estos países y regiones, las licencias que hemos recibido no son lo suficientemente amplias como para permitirnos dictar este curso en todas las ubicaciones. edX lamenta profundamente que las sanciones estadounidenses impidan que ofrezcamos todos nuestros cursos a cualquier persona, sin importar dónde viva.

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