Project

Good Manufacturing Practices (GMP) Cell and Gene Therapy Facility for manufacturing first-in-human (FIH) investigational Advanced Therapy Medicinal Products (iaTMP)

Code
I013224N
Duration
01 May 2024 → 30 April 2025
Funding
Research Foundation - Flanders (FWO)
Promotor-spokesperson
Research disciplines
  • Medical and health sciences
    • Other medical and health sciences not elsewhere classified
Keywords
mRNA/LNP vaccines Good Manifacturing Practices (GMP) Facility Advanced Therapy Medicinal Products
 
Project description

A novel facility for Cell and Gene Therapy (CGT) will be built at the Ghent University Hospital (UZ
Gent) to replace the present facility, which has become too limited in capacity, and which in the
coming years will not be up to current best practices and regulations.
In recent years, dozens of novel therapies consisting of living cells and/or nucleic acids have become
available. With these therapies several incurable cancers can now be treated successfully and genetic
diseases such as hemophilia can now be cured, often with a single injection. With the requested GMP
facility, Ghent University (UGent) intends to facilitate the research on novel CGTs for researchers
across Flanders, and internationally. Several of these novel therapies are personalized approaches,
based on the patient’s own cells. As a result, no relevant animal models are available and
fundamental knowledge can therefore only be acquired by conducting first-in-human tests. Within
the requested GMP facility, investigational CGT products will be manufactured in an ultra-sterile
environment and using ultrapure materials. This facility will speed up the development of novel
therapies in Flanders, fortifying the position of Flanders as a biopharmaceutical hotspot.
This facility allows medical researchers to build-up fundamental knowledge in this new and exciting
field of medicine, leading to novel treatments and start-up companies.