FRAUNHOFER - FRAUNHOFER Society - Fraunhofer Institute for Systems and Innovation Research ISI / Fraunhofer Institute for Cell Therapy and Immunology IZI

Fraunhofer ISI: FraunhoferInstitute for Systems and Innovation Research
The Fraunhofer Institute for Systems and Innovation Research ISI is part of the Fraunhofer Society for the promotion of Applied Research e.V., Europe’s largest application-oriented research organization. The Fraunhofer ISI Business Unit Innovations in the Health System assesses health innovations (i.e. innovative healthcare technologies and services) in terms of their potential contribution towards meeting biggest societal goals and challenges by including the contradictory interests of all involved players groups in this process.

Fraunhofer IZI: Fraunhofer Institute for Cell Therapy and Immunology
The Fraunhofer Institute for Cell Therapy and Immunology IZI investigates and develops solutions to specific problems at the interfaces of medicine, life sciences and engineering. One of the institute‘s main tasks is to conduct contract research for companies, hospitals, diagnostic laboratories and research institutes operating in the field of biotechnology, pharmaceuticals and medical engineering. The Fraunhofer IZI develops, optimizes and validates methods, materials and products within the business fields cell and gene therapy, drugs and vaccines, molecular diagnostics and immunodiagnostics, as well as extracorporeal therapies. Its areas of competence lie in cell biology, immunology, drug biochemistry, bioanalytics and bioproduction as well as process development and automation. Research in these areas is centered around developments in immuno-oncology and infectious disease pathology. The institute works in close cooperation with hospital institutions and performs quality tests besides manufacturing investigational medicinal products in line with GMP requirements. Furthermore, it supports partners in developing processes for the pharmaceutical production of ATMPs and biologicals, for example by helping them to obtain manufacturing licenses.

Role within JOIN4ATMP

The Fraunhofer ISI Business Unit Innovations in the Health System is involved in different Tasks within Work Package5 “Increasing ATMP regulatory awareness in producers and ATMP acceptance in patients and healthcare professionals” and will contribute to the achievement of this WP’s main objectives:

Improve awareness and knowledge of the regulatory processes among academic and SME ATMP developers and manufacturers;
Introduce improved information exchange to raise ATMP acceptance EU-wide and support equitable ATMP access;
Involve end-users in the ATMP development process to raise ATMP awareness, acceptance and legitimacy in the lay public.

Fraunhofer IZI will support the activities of Work package 2 "Road to standardised Good Manufacturing Practice ATMP production across the EU", by participating in a wide scope of activities:

Map ATMP manufacture regulatory criteria in different EU member states
Map ATMP manufacture organisational and infrastructural requirements
Chart guidelines for monographs for pharmaceutical-grade raw materials
Design criteria for a dynamic regulatory framework relying on new technological platforms
Design a blueprint for an EU-wide GMP unit coordination platform.
Design a set of recommendations and an adaptable regulatory framework applicable across the EU

Main contact(s)

Dr. Piret Fischer (Fraunhofer ISI)

Project partner

Dr. Ulrich, Blache (Fraunhofer IZI)

Team Lead