Cellular therapies ATMPs

somatic cell therapy

these contain cells or tissues that have been manipulated to change their biological characteristics. They can be used to cure, diagnose or prevent diseases

Gene therapy medicinal product

these contain genes that lead to a therapeutic effect. They work by inserting 'recombinant' genes into cells, 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

Tissue engineered medicinal products

these contain cells or tissues that have been modified so they can be used to repair, regenerate or replace tissue

Combined advanced-therapy medicines

these are medicines that contain one or more medical devices as an integral part of the medicine. An example of this is cells embedded in a biodegradable matrix or scaffold

What are ATMP

a cell therapy product is an ATMP when it is substantial manipulated or in case of non-homologous use.

What are non-substannital manipulations?

• cutting

• grinding

• shaping

• centrifugation

• soaking in antibiotic or antimicrobial solutions

• sterlization

• irradiation

• cell seperation, concetration or purification

• filtering

• lyophilization

• freezing

• cryopreservation

• vitrification