title: Quality control system to support comparability assessment for the Renal Bio-Replacement therapy system.
abstract: Cell therapies offer great promise for treating serious and life-threatening diseases, as cells provide the dynamic, interactive therapy that responds to the patient's condition. The spectrum of cell therapies is very broad, but each requires characterization during product development. During the development of a cell therapy, changes are made to improve product quality, purity, yield, and consistency, as well as to meet other production requirements. Multiple factors have to be considered when changes are made. A well thought-out design of comparability protocols has to reflect the international consensus set forth by the International Conference on Harmonization (ICH) and Food and Drug Administration (FDA). Comparability studies, due to their importance for the entire product development, constitute an additional challenge for the Quality System, which supports manufacturing. A comparability study was conducted to support the transfer of a cell-based technology, the Renal Bio-Replacement (RBR) system, from an academic laboratory to a contract manufacturing facility. The quality control programme supporting the RBR, and issues encountered in the comparability of the RBR therapy system, are discussed in this article.
authors.affiliation: Nephros Therapeutics Inc, Lincoln, RI 028484, USA. zpitkin@nephrostherapeutics.com
authors.forename: Z
authors.initials: Z
authors.lastname: Pitkin
mesh_terms: D064987:Cell- and Tissue-Based Therapy / Q000379:methods / Q000592:standards; D006801:Humans; D011786:Quality Control; D017582:Renal Replacement Therapy / Q000379:methods / Q000592:standards