BioCentriq offers cGMP manufacturing services for both cellular and gene therapies. We provide fast and cost effective manufacturing 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.
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
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