Process simulation as a decision support tool for biopharmaceutical process development in a South African context
type: CreativeWork
description: In 2010 the incidence of neo-natal Group B Streptococcus (GBS) disease in South Africa was 3 per 1000 live births, more than twice the global average of 1.21 per 1000 live births. A recent life cycle impact assessment showed that a new vaccine against GBS disease in South Africa could have a potential value of $ 2 million - $ 4 million /kg (R 25 million - R 50 million /kg), as an attractive investment opportunity if a novel process can be successfully synthesised and licensed commercially. In the current global market new biopharmaceutical products require innovative and expedited development pathways. To achieve this, low-cost analytical tools with short turnaround times are needed to assist with process development decision making. Process simulation is one such tool which has been shown to be useful for evaluating process development decisions without the typically expensive investment required for experimental development of a new process. Three technology platforms (stainless steel, single-use, and a hybrid of both) were identified for use in a novel process to manufacture a GBS serotype III polysaccharide-protein conjugate antigen, for formulation into a vaccine against GBS disease. The three technology choices were compared and evaluated for the novel process at two fermentation scales of 20 L and 200 L, with cost of goods (COG) used as a comparison of economic performance for the six different scenarios. It was hypothesised that single use technology would yield the lower COG at both scales compared to stainless steel. Based on a literature survey, single use technology should require lower capital costs for pilot scale processes and should also have lower operating costs due to single use equipment not requiring sterilisation in place (SIP) and cleaning in place (CIP). It was further hypothesised that hybrid technology would yield the lowest COG by combining the best properties of stainless steel and single use technologies. A 3 x 2 factorial experiment des…
abstract: In 2010 the incidence of neo-natal Group B Streptococcus (GBS) disease in South Africa was 3 per 1000 live births, more than twice the global average of 1.21 per 1000 live births. A recent life cycle impact assessment showed that a new vaccine against GBS disease in South Africa could have a potential value of $ 2 million - $ 4 million /kg (R 25 million - R 50 million /kg), as an attractive investment opportunity if a novel process can be successfully synthesised and licensed commercially. In the current global market new biopharmaceutical products require innovative and expedited development pathways. To achieve this, low-cost analytical tools with short turnaround times are needed to assist with process development decision making. Process simulation is one such tool which has been shown to be useful for evaluating process development decisions without the typically expensive investment required for experimental development of a new process. Three technology platforms (stainless steel, single-use, and a hybrid of both) were identified for use in a novel process to manufacture a GBS serotype III polysaccharide-protein conjugate antigen, for formulation into a vaccine against GBS disease. The three technology choices were compared and evaluated for the novel process at two fermentation scales of 20 L and 200 L, with cost of goods (COG) used as a comparison of economic performance for the six different scenarios. It was hypothesised that single use technology would yield the lower COG at both scales compared to stainless steel. Based on a literature survey, single use technology should require lower capital costs for pilot scale processes and should also have lower operating costs due to single use equipment not requiring sterilisation in place (SIP) and cleaning in place (CIP). It was further hypothesised that hybrid technology would yield the lowest COG by combining the best properties of stainless steel and single use technologies. A 3 x 2 factorial experiment des…
author: Collair, Wesley
keywords: Bioprocess Engineering
date published: 2020
date modified: 2026-07-22T22:23:29Z
provider: University of Cape Town
publisher: Networked Digital Library of Theses and Dissertations
type: WebPage
source organization: Centre for Bioprocess Engineering Research

PropertyValue
property ID: Handle
value: http://hdl.handle.net/11427/32553