Advanced Therapy Medicinal Products
Therapies and medicines, including regenerative medicine and more personalized treatments, are undergoing a rapid expansion. Advanced therapy medicinal products (ATMPs) are medicines for human use based on genes, cells and tissues. ATMPs are at the cutting edge of innovation and provide new opportunities to tackle a range of diseases presently with limited or no therapeutic options.
ATMPs can be classified into four main groups:
- Gene therapy medicines: these consist of genes that result in a therapeutic, prophylactic or diagnostic effect after inserting recombinant genes into humans to treat a variety of diseases (e.g. genetic disorders, cancer or long-term illnesses).
- Somatic cell therapy medicines: these are based on the administration of manipulated cells or tissues to humans, which serve to cure, diagnose or prevent diseases.
- Tissue engineered products (TEP): contain or consist of engineered cells or tissues, which are administered to humans to regenerate, repair or replace human tissue.
- Combined ATMPs: contain one or more medical devices as an integral part of the medicine. Check this link to learn more about medical devices.
Nonclinical safety assessment studies including:
- Acute and repeated exposure, available with a selection of dose routes in the relevant species.
When bench-to-bedside translational research is required, Vivotecnia is ready and willing to assist you.
For further information about ATMPs, check out this link: EMA