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Cell & Gene Therapy

Sourcing and qualification of raw materials for producing cell and gene therapies - WHITEPAPER


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There was a total of 906 regenerative medicine companies in operation globally, operating over 1000 active cell and gene therapy clinical trials in 2018. Broadly speaking there are two types of cell and gene therapy; those that use the patient’s own cells (autologous) and those that use a banked source of cells (allogeneic). Raw materials are required for both therapy types. Consideration of raw materials and supplier selection, material quality and safety assurance, current good manufacturing practice (CGMP), and other regulatory requirements are essential.

This whitepaper examines the key factors to consider while sourcing and qualifying raw materials for cell and gene therapies, such as:

  • The different types of raw materials

  • The impact of autologous vs allogeneic cells

  • Cell suppliers and sources

  • Considerations for growth media and vectors

  • Ensuring quality and safety

  • Comparability assays

  • Regulatory and CGMP considerations

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