Adaptation of the pore diffusion model to describe multi-addition batch uptake high-throughput screening experiments

Optimization‐based framework for resin selection strategies in biopharmaceutical purification process development

“…In the early stages of purification process development, different types of resins need to be tested at small scale (1.5–5000 µL) under various operating conditions, including different pH values, salt concentrations, and flow rates, to establish the resin most suited for process application at large scale . Platforms that have a capacity for high‐throughput screening (HTS) are commonly used to identify the most promising candidates for further investigation, in terms of key criteria of large scale purification, like yield, purity, and productivity . In HTS, the combination of robotic methods, parallel processing, and the miniaturization of bioprocess unit operations allows for a large number of potential process parameters to be examined within a short time, and also results in the generation of large amounts of data for evaluation.…”

“…1 Platforms that have a capacity for highthroughput screening (HTS) are commonly used to identify the most promising candidates for further investigation, in terms of key criteria of large scale purification, like yield, purity, and productivity. [2][3][4][5][6][7][8][9][10][11][12] In HTS, the combination of robotic methods, parallel processing, and the miniaturization of bioprocess unit operations allows for a large number of potential process parameters to be examined within a short time, and also results in the generation of large amounts of data for evaluation. To deal with the substantial volume of data generated from such microscale HTS experiments, rapid analysis using a systematic methodology to focus on the conditions that result in optimal overall process performance can become therefore critical.…”

High throughput chromatography strategies for potential use in the formal process characterization of a monoclonal antibody

“…The correlations are also less appropriate for systems with high concentrations of impurities with competing adsorption strength to the product, such as charge variants or aggregate levels, where the reduced separation of the single theoretical plate batch system is more pronounced (Fornstedt and Guiochon, ; Garke et al, ). The second batch strategy takes a more fundamental approach through the measurement of thermodynamic and transport parameters such as static capacity, partitioning coefficient, and product‐impurity selectivity (Kelley et al, ; Lacki, ; Traylor et al, ). This strategy is more appropriate for the measurement of conditions with interacting solutes, and performance correlations are somewhat independent of the experimental measurement system.…”