02210nas a2200265   4500008004100000022001400041245011100055210006900166260000800235300001400243490000700257520132700264653001501591653003001606653002601636653001401662653001501676100002601691700002001717700002501737700001801762700001901780700001701799856012801816       2022                        eng d  a0268-257500aMechanistic modeling of continuous capture step purification of biosimilar monoclonal antibody therapeutic0 aMechanistic modeling of continuous capture step purification of   cSEP  a2404-24190 v973 a<p>
	{BACKGROUND Continuous multicolumn Protein A chromatography offers various advantages for capture stage purification of monoclonal antibody therapeutics, like higher productivity and resin capacity utilization, lower buffer consumption, small footprint, etc. Due to the complexity of the continuous process, experimental optimization is time-consuming and cost-intensive. This investigation proposes a hybrid process development approach integrating experimental and mechanistic modeling for time- and cost-effective development and optimization of continuous Protein A affinity chromatography. RESULTS Productivity and capacity utilization of the continuous CaptureSMB process under varying operating conditions were predicted using the Chromatography Analysis and Design Toolkit (CADET) framework and validated with experimental results. Effects of critical process parameters like feed concentration (c(0)), loading breakthrough (s) and residence time (RT) on productivity and capacity utilization were evaluated. Model predictions were validated using the experimental results proving the reliability and feasibility of the modeling approach. At 15.00 +/- 0.20 mg mL(-1) feed model mAb concentration, the model-based approach predicted the best performance giving 27.56 g L-1 h(-1) productivity (RT = 2 min</p>
10aCaptureSMB10acontinuous chromatography10aMathematical modeling10aProtein A10asimulation1 aDeulgaonkar, Prashant1 aBhambure, Rahul1 aPrasad, Bhaskarjyoti1 aMishra, Ashok1 aTiwari, Sanjay1 aMody, Rustom  uhttps://library.ncl.res.in/content/mechanistic-modeling-continuous-capture-step-purification-biosimilar-monoclonal-antibody