Department of Chemical Engineering

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https://scholar.sun.ac.za/handle/10019.1/321
Department Process Engineering now has a new name, and will be known from March 2023, as Department of Chemical Engineering.

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Browsing Department of Chemical Engineering by browse.metadata.advisor "Bubb, Martin"

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    Optimisation of ultrafiltration for human serum albumin at NBI
    (Stellenbosch : Stellenbosch University, 2016-03) Bhiman, Bradley; Gorgens, Johann F.; Bubb, Martin; Stellenbosch University. Faculty of Engineering. Dept. of Process Engineering.
    ENGLISH ABSTRACT: National Bioproducts Institute (NBI) is a key plasma fractionator within the Southern African countries. Human serum albumin (HSA), is the most abundant plasma protein in human blood and has significant physiological and therapeutic benefits. The global demand for HSA is steadily increasing and this has compelled plasma fractionators to optimize the key processes that are used to manufacture this plasma derived medicinal product (PDMP). A key process in the manufacture of HSA is the use of ultrafiltration (UF), a key membrane separation technology, to remove unwanted salts and solvents from the dissolved active pharmaceutical ingredient (API). UF of protein solutions consists of several key steps including first concentration step, diafiltration steps one to five and second concentration step. Ultrafiltration performance is limited by inherent process characteristics such as concentration polarization (CP) and membrane fouling (MF). During this study, the key factors that influence the UF of HSA namely protein concentration, ethanol concentration, temperature and ionic strength, were optimized within pre-defined ranges to evaluate their impact on permeate flux and membrane performance. Permeate flux is a key determinant of process time, which directly impacts annual production capacity with a particular UF unit (C200 UF rig). A key objective of this study was to maximize production capacity through optimization of the key factors above, using the C200 UF rig. The results of this study show that protein concentration is the key factor that influenced the various steps of UF of HSA and overall production capacity. The optimum protein concentration range for maximum productivity was 60.00g/L to 100.00g/L. The optimum protein concentration for UF of HSA was approximately 100.00g/L, determined using the gel concentration model. Ionic strength diafiltration diluent (1M – 3M) reduced permeate flux during UF of HSA. Ethanol (<10% v/v) also had a reducing effect on, permeate flux during UF of HSA, with the optimum range specified between 0% (v/v) to 7.75% (v/v). Optimum permeate flux is achieved at a temperature of 25°C for UF of HSA. The optimum protein concentration for UF is within the protein concentration range for optimum productivity. Further, the proposed increase in protein concentration during UF results in a greater than 30% increase when compared to the current batch size.