"Although these types of
treatments are at an
incipient stage, they are a
reality and have become
a key piece for the
present and future medicine,
a hopeful horizon
not only for patients
but also for their
caregivers, families and
society as a whole."

The Spanish Agency of Medicines and
Health Products (AEMPS) defines
advanced therapies medicines (ATMs)
as "medicines for human use
based on genes (gene therapy), cells
(cell therapy) or tissues (tissue engineering
) and include products of
autologous, allogeneic or xenogeneic origin".

The extraordinary potential of advanced
therapies lies in offering life-changing, durable
solutions to patients
with few or no therapeutic


A type of advanced therapy that uses cells for the treatment or prevention of pathologies. These are medicines composed of cells extracted from a donor or isolated from the patient. The cells can be manipulated ex vivo to increase their number or efficacy, or altered once they have been administered to the patient, allowing them to acquire functions other than their essential activities.

gene therapy

Therapeutic technique in which a functional gene is inserted into an individual's cells to modify a genetic defect responsible for a given pathology.

tissue therapy

Biotechnological technique that uses stem cells and biomaterials to originate in the laboratory artificial tissues and tissue substitutes with heterologous or autologous origin.

Challenges of the
advanced therapies

with designation

Advanced therapies with designation
orphan are treatments based on
complex and newly manufactured processes that are intended for the treatment of
rare diseases.
Thanks to the emergence of these treatments, patients with rare or infrequent diseases will see a promising change in their quality of life.


Clean rooms are facilities that must
comply with Good Manufacturing Practice (GMP) as
essential condition for the production of
medicines for human use
For the manufacture, application and use of advanced therapies, it is
necessary to use these facilities, equipped with the necessary equipment
and personnel specialized in the application of this type of
Thus, these establishments are specially designed and
validated for this purpose. The aim is to reduce as much as possible the possible
contamination of the environment. The quality management system of the rooms

  • The staff
  • Premises and equipment
  • The documentation system
  • Production processes
  • Quality control
  • Product recalls and product inspections