The
European Medicines Agency has issued guidance on Advanced therapy medicinal
products. Advanced therapy medicinal products (ATMPs) are medicines for human
use that are based on genes, tissues or cells. They offer ground-breaking new
opportunities for the treatment of disease and injury.
ATMPs
can be classified into three main types:
gene
therapy medicines: these contain genes that lead to a therapeutic, prophylactic
or diagnostic effect. They work by inserting 'recombinant' genes into the body,
usually to treat a variety of diseases, including genetic disorders, cancer or
long-term diseases. A recombinant gene is a stretch of DNA that is created in
the laboratory, bringing together DNA from different sources; somatic-cell
therapy medicines: these contain cells or tissues that have been manipulated to
change their biological characteristics or cells or tissues not intended to be
used for the same essential functions in the body. They can be used to cure,
diagnose or prevent diseases; tissue-engineered medicines: these contain cells
or tissues that have been modified so they can be used to repair, regenerate or
replace human tissue.
In
addition, some ATMPs may contain one or more medical devices as an integral
part of the medicine, which are referred to as combined ATMPs. An example of
this is cells embedded in a biodegradable matrix or scaffold.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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