Cell and tissue-based therapies are manufactured in a laboratory setting for the subsequent implantation into human subjects, as such the highest regulatory scrutiny is in place to ensure patient safety and compliance with the law. Cell and tissue-based therapies are subject to Good Manufacturing Practice (GMP) and must be manufactured in GMP facilities. GMPs ensure that the final product is safe and of consistent quality by applying standards to design, monitoring and control of the manufacturing facility.
The FDA has specific guidance for the manufacturing of human cells, tissues and cellular and tissue-based therapies which should follow Good Tissue Practice (GTP). GTPs not only ensure top-quality and consistent products, but guarantee the safety of these biological compounds by preventing the introduction, spread and transmission of communicable disease. [7]
7. FDA. Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/current-good-tissue-practice-cgtp-and-additional-requirements-manufacturers-human-cells-tissues-and