![]() To ensure the safety and efficacy of this product, the good manufacturing practice (GMP) facility should establish a well-designed quality assurance and quality control (QA/QC) programme. Manufacturing MyDerm ® requires multiple high-risk open manipulation steps, such as tissue processing, cell culture expansion, and skin construct formation. The aim of this paper is to discuss the general overview of the quality assurance and quality control implemented in the manufacturing of cell and tissue product, with emphasis on our experience in the manufacturing of MyDerm ®, an autologous bilayered human skin substitute. ![]() Such treatments include allogeneic and xenogeneic transplants and skin substitutes such as tissue-engineered skin, cultured cells, and stem cells. Treatments for skin injuries have recently advanced tremendously.
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