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Quality Management can be more difficult than with traditional biopharmaceuticals, because of the nature of cell and gene therapies.

The goal of quality management is to make sure that any cell or gene therapy given to a patient is safe, effective, and meets a set of quality standards.

Cell and gene therapies, in comparison to traditional medicines, are more likely to be produced in small batches, especially in the case of autologous therapies, in which the patient’s own cells are transformed and then injected back into the same patient. Quality Management is difficult due to the limited amount of precious material accessible for analytical testing. Multiple batches of material can be processed at the same time, allowing for parallel testing of a large number of samples.

In this video whitepaper, we will discuss the following topics

  • How quality management in cell & gene therapy is complicated
  • What issue quality leaders need to tackle that are pertinent to cell & gene therapy
  • Key focus areas that will require prioritization and investment
  • And more