Argos Therapeutics Biomanufacturing Facility, Research Triangle Park, Durham, United States of America


Argos Therapeutics Biomanufacturing facility

Argos Therapeutics initiated the construction of a biomanufacturing facility at Research Triangle Park in Durham, North Carolina (NC), US, in October 2014. The facility will be used for manufacturing personalised immunotherapy product candidates that are used for the treatment of cancer, HIV and other serious illnesses. The facility is expected to be operational by the end of 2018.

The groundbreaking ceremony of the facility was attended by special guests, including Bill Bell, mayor of Durham, Bill Brian, Chairman Elect, Greater Durham Chamber of Commerce, and Michael Page, chairman, Durham County Commission.

Details of the biomanufacturing facility in Research Triangle Park

The new biomanufacturing facility will have a total floor space of 100,000ft². It will include sophisticated equipment for automated manufacturing of Arcelis-based products. It will initially produce Argos' lead oncology product candidate AGS-003, which is being evaluated in the ADAPT Phase III clinical trials for the treatment of metastatic renal cell carcinoma (mRCC).

"The facility is expected to be operational by the end of 2018."

The project has created 100 construction jobs, while an additional 230 jobs are will be created in future.

Arcelis technology platform in the Argos Therapeutics' biomanufacturing facility

The new facility will use Arcelis® technology platform for automated manufacturing of personalised immunotherapy product candidates. The technology captures altered and different antigens that are specific to each patient's disease. It can help to get rid of tumour- and disease-induced immunosuppression in cancer and HIV by extracting a durable memory T-cell response without using toxic adjuvants.

The process uses a small tumour or blood sample along with the patient's dendritic cells, which can be collected and optimised after a single leukapheresis procedure. It then uses RNA isolated from the patient´s disease sample to programme dendritic cells to target disease antigens. The antigen-loaded dendritic cells are formulated into the patient´s plasma and injected intradermally.

Contractors involved

The new biomanufacturing facility construction contract was awarded to Keith Corporation. Invetech was contracted to develop and supply manufacturing systems to support production needs for fully personalised immunotherapies in November 2014. The contractual scope includes offering services, technology and equipment to support the design, development, supply and maintenance of customised manufacturing systems.



Catalent Pharma Solutions opened a state-of-the-art bio-manufacturing centre of excellence in Madison, Wisconsin, US, in April 2013.


In January 2015, Saint-Gobain's Performance Plastics division was contracted to provide design, integrate and scale production of a range of disposables for use in the automated manufacturing of AGS-003.

Financing

The total estimated investment for the construction of the biomanufacturing facility is $57m. The state of North Carolina, Durham County, the City of Durham, and the North Carolina Biotechnology Center contributed a total of $9.5m incentives for the project.

The incentive package offered by North Carolina department of commerce is $7.1m, which includes a job development investment grant of $4.5m, education and on-the-job training assistance of $600,000, sales tax exemption on qualifying equipment of $1.8m, and a $200,000 Economic Development Award from the North Carolina Biotechnology Center.

The NC Commerce, the City of Durham and Durham County contributed the rest of the $2.35m incentives package, which includes a cash grant of $1.85m and $500,000 in on-the-job training assistance.

Marketing commentary

Argos Therapeutics is a biopharmaceutical company focused on the development of fully personalised immunotherapies based on Arcelis technology platform for treating cancer and infectious diseases. The most advanced product candidates of the company include AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC), and AGS-004 for the treatment of HIV.