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Making a Cell Therapy

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.

What you'll learn

  • Cellular therapies are living products that are only effective when delivered alive. This course will introduce the
  • 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
  • .
  • 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
  • .
  • 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
  • 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
  • .
  • Cell therapies are part of the larger pharmaceutical industry, which operates under regulatory oversight. This course will teach about how drugs are regulated and
  • .
  • cell biology and immunology
  • cell therapy manufacturing practices
  • analytics for cell therapy
  • industrialization of cell therapies
  • regulatory requirements for cell therapies

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Rating Not enough ratings
Length 7 weeks
Effort 5 - 7 hours per week
Starts On Demand (Start anytime)
Cost $149
From Massachusetts Institute of Technology via edX
Instructors Krystyn Van Vliet, Paul W. Barone, Caleb Neufeld, Stacy L. Springs
Download Videos On all desktop and mobile devices
Language English
Subjects Science
Tags Biology & Life Sciences

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Careers

An overview of related careers and their average salaries in the US. Bars indicate income percentile.

Cell Culture Biologist $50k

drawer cell operator $60k

Cell tech. 3 $63k

Cell Site Technician 2 $63k

Biologist – GMP cell culture/cell banking $74k

Cell Biologist $81k

Laser Cell Leader $94k

Cell Planning Engineer $101k

Senior Clinical Therapies Specialist $105k

Cell Therapy R&D Leader $113k

cell tech Manager $113k

Product Cell Leader 2 $138k

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Rating Not enough ratings
Length 7 weeks
Effort 5 - 7 hours per week
Starts On Demand (Start anytime)
Cost $149
From Massachusetts Institute of Technology via edX
Instructors Krystyn Van Vliet, Paul W. Barone, Caleb Neufeld, Stacy L. Springs
Download Videos On all desktop and mobile devices
Language English
Subjects Science
Tags Biology & Life Sciences

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