Module 9 2024

03/09/2024

What is an ATMP and How it is Defined?

Contain or consist of Autologous, allogeneic, or xenogenic cells or viruses Recombinant nucleic acid

ATMPs requirements Different functional and biological properties in processed cells More than minimally manipulated cells or tissues Produced in GMP and under a routine basis

Other than transplantation products

The Organisation for Professionals in Regulatory Affairs

13

Minimal and Non-Minimal Manipulations

Minimal manipulations

Non minimal manipulations

Extended cell culture Genetic modification Differentiation / activation with growth factors Enzymatic digestion of tissue

Cryopreservation, Filtration,

Sterilization Separation, Concentration Purification Centrifugation, Filtering Radiolabelling of leukocytes

The Organisation for Professionals in Regulatory Affairs

14

7