Biotherapeutics manufacturing facility relocation
Abzena is expanding its biotherapeutics manufacturing operations by relocating to a new leased facility in Lusk Boulevard, San Diego, US.
The facility will be used for the development and manufacturing of monoclonal antibodies (mAb) and other recombinant proteins for clinical trials. It will enable the company to meet a growing demand for biologics, antibody drug conjugates (ADC) and various complex small molecules.
Abzena relocated its biomanufacturing process and analytical development unit into the new facility in May 2018. Installation of new bioreactors and manufacturing units is currently ongoing and is expected to be completed by early-2019.
Abzena secured a lease for a 50,000ft² facility at Lusk Boulevard, San Diego, in December 2017.
With an estimated investment of $20m, the new facility will house large stirred tank bioreactors and biomanufacturing cleanrooms that will house a two-train current good manufacturing practice (cGMP) operation.
The GMP facility will be equipped with Sartorius’ 500l and 2,000l single-use bioreactors based on conventional stirred-tank design.
The facility will also feature a process development lab, which will enable faster scale-up in clinical manufacturing. The lab will be equipped with innovative technologies such as Sartorius Stedim’s Ambr® 250 bioreactor system.
Abzena will also add cell line development capacity and a chemistry laboratory space.
The new facility will be installed with self-contained Sartorius BIOSTAT® STR bioreactor range, which features integrated Flexsafe STR® single-use bags and upgraded software and hardware to ensure time and cost reduction of bioprocess scale-up.
The Flexsafe STR® bags are made up of proprietary, robust multi-layer S80 polyethylene film with state-of-the-art single-use sensors. The bags avoid cross-contamination and save time in set-up, validation, cleaning and sterilisation.
The bioreactor ensures efficient oxygen transfer, mixing, and carbon dioxide stripping, which enhances the performance of cell culture with reproducible high-density growth of various kinds of cell lines. The bioreactor is suitable for safe manufacturing of vaccines and recombinant proteins in the cGMP facility.
The Ambr@ 250 bioreactor system is a single-use, fully-automated system for process development. It has a broad range of application in process optimisation, cell culture, and microbial fermentation. The system contains impellers for stirring, pH and dissolved oxygen (DO) sensor and ports for connection with system’s liquid and gas lines.
Abzena awarded Sartorius Stedim Biotech a biomanufacturing equipment supply and services contract to supply bioprocess reactor equipment and process analytic software as well as to assist in the designing of the new facility in January 2018.
Abzena is involved in the development and manufacture of biopharmaceuticals, antibodies and other proteins. The company uses 10l to 500l single-use wave-based bioreactor systems for cGMP manufacturing.
Abzena has completed 320 projects and has 40 products in clinical trials. The company is also present in Bristol, Pennsylvania, and Cambridge, UK.
The company completed the installation of a 500l stirred tank bioreactor at the existing facility in San Diego in January 2018, which is sufficient to meet the current demand.
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