cGMP Manufacturing for Cell & Gene Therapies
In May 2020 our cGMP manufacturing services for both cellular and gene production will be commissioned allowing for the fast and cost effective manufacture of clinical grade material for investigational trials. Our facility includes two Grade B clean rooms containing a total of five fully equipped laboratory benches.
We support pre competitive sponsored projects and fee-for-service proprietary projects and all IP remains the property of the project owners.
Grade B FDA Compliant Clean Room
The Center is equipped with automated cell manufacturing stations, QC and analytical test centers. The two controlled-access, ISO 7 GMP suites are designed to process multiple patient samples and have dedicated HVAC systems.
In addition, all equipment in each suite and cryo-storage lab is connected to UPS systems, a backup generator and a live monitoring system. The cell therapy suite has an FDA-compliant Manufacturing Execution System (MES) for tracking and documenting the processing of the cell therapy product.
Cell cultivation viral vector production capacity of 200L
Cell types: Stem cells, T-cells, NK cells, T-NK cells, HEK 293, antigen specific T-cells and others
Dedicated production suite for viral vector manufacturing
Production in single-use bioreactors with capabilities in suspension and adherent cell culture
Purification by chromatographic methods or by ultracentrifugation
Formulation and final purified bulk manufacture
QA and QC validated clinical production