Forum on Regenerative Medicine - Focus Area: Manufacturing Regenerative Therapies
Regenerative medicine therapies rely on living cells and tissues, which are inherently variable, and this adds a fundamental complexity to the manufacturing and scale-up process that is not found in the manufacturing of most non-biologic products. The Forum has identified several areas of interest in the area of manufacturing and cell/tissue sourcing, including defining and measuring critical quality attributes for regenerative medicine products and materials, developing standards for clinical trials and manufacturing, and exploring the challenges of manufacturing “living” therapies. Forum members are interested in exploring the challenges in manufacturing and production of viral vectors, including logistical and scale-up challenges related to manufacturing and administering those therapies at the point of care. Below are the Forum resources that pertain to manufacturing regenerative therapies.
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