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, cell, and tissues. ATMPs are at the cutting edge of innovation and provide new opportunities to tackle a range of diseases with limited or no therapeutic options.
ATMPs can be classified into four main groups
- Gene therapy medicines: these consists in genes that lead to a therapeutic, prophylactic or diagnostic effect by inserting recombinant genes into humans to treat a variety of diseases (e.g., genetic disorders, cancer or long.term diseases).
- Somatic Cell therapy medicines: these are based on the administration of manipulated cells or tissues into humans that can be used to cure, diagnose or prevent diseases.
- Tissue engineered products (TEP): contain/consist of engineered cells/tissues, which are administered to the human to regenerate, repair or replace a human tissue.
- Combined ATMPs: contain one or more medical devices as an integral part of the medicine. Check out medical devices.
Non-clinical safety assessment including e.g
- Biodistribution studies
- Tumorigenicity studies
- Immunogenicity studies
- Acute and repeated exposure, available with the range of dose routes in the relevant species.
Vivotecnia has a wealth of knowledge about preclinical studies with ATMPs.
The ATMPs require sequential testing involving long periods. Our highly experienced team will help you to design your studies according to regulatory requirements.
When translational research from bench to bedside is required, Vivotecnia is there to assist you.
The main European standard reference is the Directive 2001/83/EC and Regulation (EC) Nº.1394/2007 establishing the European committee for Advances therapies.
For further information about ATMP, check out these link: EMA
Please contact us to discuss your particular needs and goals.