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Related Concept Videos

Cell Lines01:16

Cell Lines

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A cell line is a population of cells grown in vitro that can be subcultured over several generations. Normal cells cease to divide after a certain number of cell divisions, a process known as replicative senescence. This number, called the Hayflick limit, was conceptualized by Leonard Hayflick in 1961 when he observed that fetal cells grown in culture could only divide 40-60 times. This limit is due to the shortening of the telomeres during each round of cell division, preventing cell division...
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Related Experiment Video

Updated: May 27, 2025

Freezing, Thawing, and Packaging Cells for Transport
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Fellowship training for cellular therapy laboratory directors.

Ashley A Krull1, Margaret A DiGuardo2, Michael C Deeds3

  • 1Division of Hematology, Wexner Medical Center, Ohio State University, Columbus, Ohio, United States.

Cytotherapy
|February 19, 2025
PubMed
Summary

Mayo Clinic

Keywords:
cellular therapyfellowshiplaboratory directortraining

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Area of Science:

  • Cellular Therapy Manufacturing
  • Biotechnology Leadership
  • Regulatory Science in CGT

Background:

  • Cell and gene therapy (CGT) manufacturing requires specialized leadership.
  • Existing training programs may not adequately prepare professionals for CGT laboratory directorship.

Purpose of the Study:

  • To describe the development and outcomes of Mayo Clinic's Cellular Therapy Fellowship (CTF) program.
  • To provide a model for training future leaders in CGT manufacturing and laboratory management.

Main Methods:

  • Integrated hands-on cleanroom manufacturing with didactic training in quality systems and regulatory science.
  • Structured rotations in manufacturing, quality assurance, and process development.
  • Supervised 'Acting Director' role for real-time decision-making.

Main Results:

  • Trained fellows from diverse backgrounds (PhD, MD) in CGT manufacturing platforms (e.g., CAR-T, MSCs).
  • Graduates demonstrated expertise in cGMP manufacturing, quality, and regulatory affairs.
  • Program fostered translational research, leading to publications and regulatory submissions.

Conclusions:

  • The CTF program effectively prepares individuals for leadership roles in CGT manufacturing.
  • This fellowship model can be adopted by other institutions to cultivate CGT leaders.
  • Successful training is crucial for advancing cell and gene therapy development and accessibility.