IMPLEMENTATION OF INTERNAL CONTROLS AND THE SUSTAINABILITY OF SMEs IN HARARE IN ZIMBABWE

Inspired by the assertion that preventative measures can prevent the failure of business enterprises, this paper sought to determine the types of internal controls and the degree to which SMEs implemented them in the central business district of Harare in Zimbabwe. By completing semi-structured questionnaires, the 135 respondents generated the quantitative data, which was analysed utilising Version 25 of the Statistical Package for the Social Sciences (SPSS) software. The results revealed that the conventional internal controls which are customary in larger business enterprises were either absent or not adequately implemented in the SMEs. A cross-gender comparison suggested that female-led SMEs were more likely to implement internal control systems than their male counterparts. By empirically justifying the need for internal control systems in SMEs, this paper contributes to both theory and practice, by reaffirming the effectiveness of internal controls and emphasising how their effective implementation can increase the sustainability of this business cohort

A quantitative, multi-national and multi-stakeholder assessment of barriers to the adoption of cell therapies

Cellular therapies, such as stem cell based treatments, have been widely researched and numerous products and treatments have been developed. Despite this, there has been relatively limited use of these technologies in the healthcare sector. This study sought to investigate the perceived barriers to this more widespread adoption. An anonymous online questionnaire was developed, based on the findings of a pilot study. This was distributed to an audience of clinicians, researchers, and commercial experts in 13 countries. The results were analysed for all respondents, and also sub-grouped by geographical region, and by profession of respondents. The results of the study showed that the most significant barrier was manufacturing, with other factors such as efficacy, regulation, and cost-effectiveness being identified by the different groups. This study further demonstrates the need for these important issues to be addressed during the development of cellular therapies to enable more widespread adoption of these treatments.JS is funded by an MRC UK Studentship

Bioprocessing automation in cell therapy manufacturing: Outcomes of special interest group automation workshop

Phacilitate held a Special Interest Group workshop event in Edinburgh, UK, in May 2017. The event brought together leading stakeholders in the cell therapy bioprocessing field to identify present and future challenges and propose potential solutions to automation in cell therapy bioprocessing. Here, we review and summarize discussions from the event. Deep biological understanding of a product, its mechanism of action and indication pathogenesis underpin many factors relating to bioprocessing and automation. To fully exploit the opportunities of bioprocess automation, therapeutics developers must closely consider whether an automation strategy is applicable, how to design an ‘automatable’ bioprocess and how to implement process modifications with minimal disruption. Major decisions around bioprocess automation strategy should involve all relevant stakeholders; communication between technical and business strategy decision-makers is of particular importance. Developers should leverage automation to implement in-process testing, in turn applicable to process optimization, quality assurance (QA)/ quality control (QC), batch failure control, adaptive manufacturing and regulatory demands, but a lack of precedent and technical opportunities can complicate such efforts. Sparse standardization across product characterization, hardware components and software platforms is perceived to complicate efforts to implement automation. The use of advanced algorithmic approaches such as machine learning may have application to bioprocess and supply chain optimization. Automation can substantially de-risk the wider supply chain, including tracking and traceability, cryopreservation and thawing and logistics. The regulatory implications of automation are currently unclear because few hardware options exist and novel solutions require case-by-case validation, but automation can present attractive regulatory incentives

Scalable purification of viral vectors for gene therapy: An appraisal of downstream processing approaches

Process concerns associated with viral-vectors gene delivery currently focus on effective purification, as described by these authors from the Centre for the Advancement of Sustainable Medical Innovation and Sartorius Stedim Biotech. For research into cell-delivered gene therapy platforms to continue toward development, process characterization and development work are still in need of refinement

Scalable purification of viral vectors for gene therapy: An appraisal of downstream processing approaches

Process concerns associated with viral-vectors gene delivery currently focus on effective purification, as described by these authors from the Centre for the Advancement of Sustainable Medical Innovation and Sartorius Stedim Biotech. For research into cell-delivered gene therapy platforms to continue toward development, process characterization and development work are still in need of refinement