![]() ![]() The rapid growing number of autologous products that are entering the pipeline is evidence to the growth potential of this therapeutic approach. Why are autologous cell therapies relevant? Future Guide updates will address Allogeneic products and other platforms. In recognition of this, the new Guide focuses on autologous cell therapies while providing content that may be applicable to other types of ATMPs. The ISPE Guide: Advanced Therapy Medicinal Products (ATMPs) Autologous Cell Therapy acknowledges that the term ATMP is quite broad and that these are emerging therapies utilizing rapidly evolving technology and equipment. Although a variety of methods can be used to deliver the genetic materials into the target cells and tissues, modified viral vectors represent one of the more common delivery routes because of their transduction efficiency for therapeutic genes. Gene therapy active substance contains recombinant nucleic acid that will regulate, repair, replace, add, or delete a genetic sequence in the patient. The second, gene therapy products, refers to a rapidly growing field of medicine in which genes are introduced into the body to treat or prevent diseases. ![]() There are two categories of cell therapy products: Autologous: cells are derived from a single patient and returned to the same patient after in vitro manipulation and Allogeneic: cells are derived from multiple donors and the final cell therapy can be used to treat many different patients. The first, cell therapy products, are manipulated whole living cells, that are introduced into the patient and act at the cellular level to treat disease or injury. ![]() There are two primary focus areas for ATMPs. This is in contrast with traditional manufacturing processes for compounds that are synthetically derived (i.e., small molecule) or proteins or peptides expressed by cellular systems (i.e., large molecule biopharmaceuticals). ATMPs include cells, engineered tissues, or the manipulation of the patient’s genome. This is often referred to as personalized medicine by many. What are Advanced Therapy Medicinal Products (ATMPs)?ĪTMPs are based on genes, cells, or tissues delivered to patients to provide a therapeutic benefit based on a specific target of interest. ![]()
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