生物制药
重新使用
单克隆抗体
色谱法
产量(工程)
化学
产品(数学)
制造工艺
工艺工程
最终产品
计算机科学
质量(理念)
抗体
数学
材料科学
生物技术
废物管理
工程类
生物
复合材料
市场经济
几何学
经济
免疫学
哲学
认识论
作者
Nivetita Ravi,Javier Pascual Huerta,Gisela Ferreira
摘要
Abstract In good manufacturing practice (GMP) facilities in the biopharmaceutical industry, chromatography resins are largely underutilized during purification of single drug products during clinical production. Chromatography resins are dedicated to a specific product and disposed of, after only a fraction of their lifetime due to concerns of potential product carryover from one program to another. In this study, we follow a resin lifetime methodology typically used for commercial submissions and apply it to determine the feasibility of purifying different products on a Protein A MabSelect PrismA™ resin. Three distinct monoclonal antibodies were used as model molecules. Column performance was monitored through chromatogram profiles, yield, clearance capability of selected media components, pressure and product quality. A protein carryover study was designed to demonstrate that the column cleaning procedures reduced protein carryover to safe cleanliness levels regardless of multiple product contact cycles and the order in which the mAbs are captured. Data show that up to 90 total cycles (30 cycles per antibody), there was negligible protein carryover and impact on process performance. Product quality was consistent, with the only meaningful trends found for the leached Protein A ligand, without affecting the conclusion of the study. While the study was restricted to three antibodies, the proof of concept for resin reuse was demonstrated.
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