In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|October 29, 2014
Argos Therapeutics Breaks Ground on Biomanufacturing Facility
Author(s)BioPharm International Editors
The new Argos biomanufacturing facility in North Carolina will include automated production using the company's Arcelis technology.
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Argos Therapeutics, a biopharmaceutical company focused on personalized immunotherapies, broke ground on a new 100,000-square-foot biomanufacturing facility in the Research Triangle Park area in North Carolina. The facility is expected to open in the first quarter of 2016.
The facility will support automated production of the company's Arcelis-based personalized immunotherapy product candidates for the treatment of cancer and infectious disease. The Arcelis process uses a small tumor or blood sample along with the patient’s own dendritic cells, which are collected and optimized following a single leukapheresis procedure. The process uses RNA isolated from the patient´s disease sample to program dendritic cells to target disease antigens. The company's lead oncology product candidate, AGS-003, is currently being evaluated in a Phase III clinical trial for the treatment of metastatic renal cell carcinoma.
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