GMP Production Facility
GMP Production Facility
The GMP production facility provides the production of ATMPs according to GMP (for ATMP) guidelines and under our GMP manufacturer license.
The future state-of the–art Cleanroom Facility will consist of 6 cleanrooms and will be well equipped with a large variety of validated equipment. This provides sufficient capacity for projects to move towards clinical application without delay. Because of the flexibility in design, the facility is able to harbor new equipment as well.
Our team of technicians will be trained to produce the new ATMPs. The GMP production staff will be trained to facilitate production and perform batch review.
Storage of final products can be provided accordingly to the product specifications.
Certification and batch release will be performed by a QP from the quality department of the Pharmacy of the UMC Utrecht.
Product portfolio
- Process and aseptic validation runs of new productions coming from the GMP sim.
- GMP production of ATMPs including monitoring and QC analysis of final products.
- Certification of batch release of ATMP s in accordance with GMP and IMPD for clinical application (QP of hospital pharmacy).
- Reception, storage and transport of ATMPs.
- Preparing ATMPs for administration.
- Reception, processing, storage and transport of cellular starting materials, raw materials, disposables etc.
- Production of semi-manufactured products (i.e. growth factors).
