Advanced Therapies Unit
Presentation
The Advanced Therapies Unit of Sant Pau Research Institute supports the development and manufacturing of personalized biological medicines in the Sant Pau environment. With a high-precision and quality infrastructure, it drives new gene, cell and regenerative medicine therapies. It also facilitates the conduct of clinical trials and promotes technology transfer so that advances reach patients in the form of innovative personalized medicine treatments.
The main objectives of the unit are:
Development of New Therapies: research and develop new gene, cell and regenerative medicine therapies that can offer new solutions for diseases that currently have no effective treatment.
Conducting clinical trials: having the facilities and personnel to carry out clinical trials of these new developments, guaranteeing the efficacy and safety of advanced therapies in patients.
Technology Transfer: Promote collaboration with biotechnology and pharmaceutical companies to ensure that scientific discoveries are translated into products available on the market.
Who we are
Functions
- Manufacturing of Advanced Therapy Medicinal Products for clinical use in compliance with Good Manufacturing Practices (EudraLex Volume 4. Part IV).
- Scale-up and validation of the manufacturing process of clinically relevant investigational products for authorization application (from bench to clinic).
- Development and writing of CTD module 3 for new products with complete preclinical regulatory authorization.
- Contract manufacturing of Advanced Therapy Medicinal Products for authorized clinical trials.
- Production of viral vectors dedicated to the manufacturing of Advanced Therapy Medicinal Products.
Equipment
- 1x GMP-compliant facility (Grade D and C areas).
- 1x Restricted Access Barrier System (RABS).
- 1x Laminar flow cabinet Bio II/A.
- 4x Airborne particle counters.
- 2x CliniMACS Prodigy.
- 2x Microbial air samplers.
- 2x Tube sealers.
- 2x Tube welders.
- 1x Cell counter.
- 1x Flow cytometer MACSQuant Analyzer 10.
- 1x Refrigerated centrifuge.
- 1x Inverted microscope.