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GMP Research & Development Use in Healthcare

Gene, cell and immunotherapy

The course content is based on, and is a specialisation of, previous knowledge in biochemistry, cell and molecular biology from the undergraduate programme. The course is divided into three fields, cell-, gene- and immunotherapy. The course includes diverse subjects such as Good manufacturing practice (GMP), Advanced Therapy Medicinal Products (ATMP), both viral and non-viral gene therapy, gene editing, oligonucleotide- and mRNA treatments, genetically modified cells and antibodies that influence the immune system. Diagnostics methods connected to the treatments will also be discussed.

Course info

  • Type: University Course
  • Organization: Karolinska Institutet
  • Language: English
  • Place: Virtual
Course Information

Photo: Karolinska Institutet | Andreas Andersson

 

The aim of the course is that the student should obtain solid knowledge in immune, gene and cell therapy including diagnostics methods and treatments in both clinical routine and during development. The achieved level of knowledge should allow the student to participate in research projects in the area and the student should be able to give an account of what Good manufacturing practice (GMP) – certified activities are.

Knowledge and understanding

  • Explain the state of knowledge in gene, cell and immunotherapy, including gene editing with CRISPR, allogeneic stem cell transplantation, CAR T cell therapy, oligonucleotides, immunotherapies and clinical use of these.
  • Explain how immune, gene and cell therapies, such as CRISPR and CAR T cells, are produced and how they can cure monogenetic diseases and cancer.
  • Explain methods in GMP production, requirements to produce cell therapies and laws and rules regarding stem cell transplantation.
  • Compare the pros and cons of the different modalities of gene editing, allogeneic stem cell transplantation and oligonucleotides for the treatment of monogenetic diseases

Skills and abilities

  • Analyse GMP workflows and propose how they can be improved.

Values and perspectives

  • Demonstrate self-awareness and individual responsibility concerning knowledge development
  • Discuss limitations and ethical issues in the area such as potential risks and effects of CRISPR/Cas9 gene editing, nucleic acid therapies and cell therapies.
  • Reflect on the supply and demand of gene therapeutics drugs from a global perspective

Course code: 3BL009
Course format: University Level
Course duration: 7.5 ECTS