This center, launched by Atlanpole Biotherapy cluster, will be dedicated to good manufacturing practices (GMP) in the field of life sciences.
It will mainly welcome players or future players of the biopharma and pharma industries but also those from food and cosmetics industries.
The project now associates three main partners:
Oniris,
Nantes University, the Atlanpole Biotherapies cluster and several of its stakeholders such as
Vivalis,
Clean Cells or
UTCG. Each partner brings its expertise in a service training or basic education, its industrial network and its expertise in GMP.
Depending on trainees’ origins, the institute will offer:
- Workshops to update knowledge in manufacturing and quality technologies, processes and regulations for :
- manufacturing and quality insurance managers
- people involved in manufacturing and quality support functions
- A variety of 2-5 day-long modules :
a. cGMP transversal module
b. Methods validation
c. cGMP applied to cell therapy/tissue engineering
d. cGMP applied to gene therapy
e. cGMP applied to upstream processing
f. cGMP applied to downstream processing
g. cGMP applied to vaccines…
- for people connected to the manufacturing processes that need to refresh its GMP reference table
- for incomers, to be aware of the GMP reference table
- for pharma or biotech students
- Customized modules
- for people that need retraining courses
- for people that need to improve specific behaviours…
The heart of the training offering relies on these modules envisioned in a practical and industrial approach of quality management from reception of raw materials to finished product release. According to this concept, modules will be delivered by industrial experts of different bioprocesses, in a GMP-like facility equipped with bioreactors, chromatography systems etc...