Cell and gene therapy manufacturing centre
BioCentriq is a clinical manufacturing facility for cell and gene therapies under development at the New Jersey Institute of Technology (NJIT) university in Newark, New Jersey, US, the first cell and gene therapy development and manufacturing centre established on a university campus in the country.
The manufacturing centre, also the first such facility in Newark, is being developed by the Biopharma Division of NJIT’s New Jersey Innovation Institute (NJII).
It is housed at NJIT’s Life Sciences and Engineering Center and comes after the opening of BioCentriq’s centre for process development at the Rutgers Medical School in Newark in 2019.
The cell and gene therapy process development and clinical manufacturing centre, BioCentriq, is scheduled to be operational in Summer 2020.
The advanced therapy development centre is located on the top level of the Life Sciences and Engineering Center. It complies with the standards of the US Food and Drug Administration (FDA).
The current good manufacturing practice (cGMP) facility of the process development and clinical manufacturing organisation (CDMO) will feature process development, automated stations for clinical manufacturing, analytical test centres and advanced quality systems.
Construction of the centre is in the final phase, while the qualification and validation process of the manufacturing processes, facility and equipment is underway.
It will include two controlled-access ISO 7 cGMP suites, with one each for the clinical production of cell therapy and gene therapy. A pilot plant dedicated to therapy process development is also being created to increase the production of cell and gene therapy products.
GMP suites will be installed with dedicated heating, ventilation, and air conditioning (HVAC) systems and have the capability to process multiple samples. The suites and the cryo-storage lab are supported by a live monitoring system, uninterruptible power supply (UPS) systems, and a back-up generator.
The suite designed for cell therapy will have a US Food and Drug Administration (FDA)-compliant manufacturing execution system (MES) to document and track the processing of products. Two Grade B cleanrooms will also be provided including five laboratory benches.
BioCentriq will also offer workforce-development programmes to improve skills of students and future workforce by partnering with leading pharmaceutical industries, training institutes, the US federal government, and funding agencies such as the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL).
The programme will aim to offer custom and general training to prepare the workforce with the skill set required for the manufacturing of biologics and cell therapy.
BioCentriq offers development and optimisation of cell and gene therapy products by involving a dedicated team of scientific experts in that particular field. Included factors in optimisation are vector selection, cell growth, and yield.
Types of cells covered are natural killer (NK) cells, T-cells, T-NK cells, stem cells, antigen-specific T-cells and HEK 293.
The facility can replicate the research and development processes with transformation and optimisation. It will be able to fast-track the production of clinical-grade material for investigational trials.
BioCentriq will be equipped with a dedicated single-use bioreactor production suite for viral vector manufacturing with a 200L production capacity.
It will feature suspension and adherent cell culture, formulation and final purified bulk production capabilities. Customers will be able to use purification services that will be provided through ultracentrifugation or chromatographic techniques.
Biopharma Division of NJII was formed in 2015 and includes BioCentriq and a programme for workforce development, as well as an incubator initiative known as BioFoundry.
The Biopharma Division is focused on helping the pharmaceutical industry overcome the challenges in the development of potential cell and gene therapies.
The incubator supports early-stage biotech companies in securing capital, mentor guidance, and resources required for their growth. BioFoundary has tie-ups with 33 universities in New Jersey, 3,000 connections and helped approximately 12 new start-ups.
NJII is a non-profit organisation that supports cell and gene therapy development and manufacturing through cooperation and transformation.
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