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SARS-COV-2 diagnostic PCR test kit

CSIR and CapeBio lead development of local SARS-COV-2 diagnostic PCR test kit
 

An overburdened demand, coupled with a worldwide shortage of rapid Covid-19 test kits, prompted the CSIR and CapeBio to demonstrate their expertise in biomanufacturing as a solution to provide the country, and the region, with a locally developed PCR test kit for Covid-19.

In early 2020, the CSIR, in collaboration with CapeBio, demonstrated the efficiency of the biomanufacturing process for two enzymes, which were combined to formulate a locally produced one-step Covid-19 diagnostic assay.

The diagnostic assay has been validated in a clinical setting and proven to have the capability to detect coronavirus 2 (SARS CoV-2)-specific genetic biomarkers. Furthermore, the single-step format of the diagnostic assay reduces the turnaround time of tests and assists in managing and monitoring the spread of SARS CoV-2.

Additionally, external evaluation by the National Health Laboratory Service was passed, and the South African Health Products Regulatory Authority subsequently licensed Cape Bio to manufacture the diagnostic kit at their facility in Centurion.

This significant milestone, which took place in under a year, resulted in the kit hitting the local market in August 2021. According to CapeBio CEO, Daniel Ndima, at full operational capacity, the company is able to produce up to 5 000 kits a day, with each kit providing 1 000 tests.

This is a clear demonstration that the CSIR, through its industrialisation strategy and commitment to assisting new and emerging small, medium and micro enterprises, is touching lives through innovative biomanufacturing processes.

The research and development funded by the South African Medical Research Council and the Technology Innovation Agency enables a faster response in terms of active case identification, quarantine and contact tracing. Additionally, the localisation of the production of these reagents continues to increase accessibility to locally produced diagnostic kits – a very significant milestone that will reduce the country’s reliance on international suppliers.

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CSIR and CapeBio lead development of local SAR-COV-2 diagnostic PCR test kit
 

An overburdened demand, coupled with a worldwide shortage of rapid Covid-19 test kits, prompted the CSIR and CapeBio to demonstrate their expertise in biomanufacturing as a solution to provide the country, and the region, with a locally developed PCR test kit for Covid-19.

In early 2020, the CSIR, in collaboration with CapeBio, demonstrated the efficiency of the biomanufacturing process for two enzymes, which were combined to formulate a locally produced one-step Covid-19 diagnostic assay.

The diagnostic assay has been validated in a clinical setting and proven to have the capability to detect coronavirus 2 (SARS CoV-2)-specific genetic biomarkers. Furthermore, the single-step format of the diagnostic assay reduces the turnaround time of tests and assists in managing and monitoring the spread of SARS CoV-2.

Additionally, external evaluation by the National Health Laboratory Service was passed, and the South African Health Products Regulatory Authority subsequently licensed Cape Bio to manufacture the diagnostic kit at their facility in Centurion.

This significant milestone, which took place in under a year, resulted in the kit hitting the local market in August 2021. According to CapeBio CEO, Daniel Ndima, at full operational capacity, the company is able to produce up to 5 000 kits a day, with each kit providing 1 000 tests.

This is a clear demonstration that the CSIR, through its industrialisation strategy and commitment to assisting new and emerging small, medium and micro enterprises, is touching lives through innovative biomanufacturing processes.

The research and development funded by the South African Medical Research Council and the Technology Innovation Agency enables a faster response in terms of active case identification, quarantine and contact tracing. Additionally, the localisation of the production of these reagents continues to increase accessibility to locally produced diagnostic kits – a very significant milestone that will reduce the country’s reliance on international suppliers.

 

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Kwezi’s main research interests are in the combined fields of applied biochemistry and enzymology, structural biology and in recombinant production of enzymes for industrial applications, including reagent enzymes for use as molecular biology tools. Kwezi’s research interests also include the production of vaccines, antibodies and biosimilars through the use of plant-based expression systems.

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FAQ

Q. How does the CSIR protect intellectual property (IP) in a collaborative project or partnership?
 

A. The CSIR is guided by the Intellectual Property Rights (IPR) from Publicly Financed Research and Development Act, 2008 (Act 51 of 2008).                               

A private entity or organisation can co-own IP that falls under the IPR Act if there has been a contribution of resources by the private entity or organisation, and:

  • It includes background IP;
  • There is joint IP creatorship;
  • Appropriate arrangements are made for benefit-sharing with IP creators at the institution; and
  • An agreement for commercialisation of the IP is concluded.
     

Note that all four of these requirements must be met.
 

Q. What support structures are available at the CSIR for entities that or individuals who want to collaborate on projects?
 

A. The CSIR offers technical incubation through its industry-facing facilities, which provide small, medium and micro enterprises and industry partners with access to specialised facilities and skills as part of the Industry Innovation Partnership Fund, supported by the Department of Science and Innovation. A request for participation call is usually sent out on a periodic basis and successful applicants have access to large-scale prototyping and pre-commercial manufacturing infrastructure, equipment, expertise and access to business and technical networks.

Research, development and innovation activities range from laboratory-scale validation to technology prototyping and pilot manufacture. For more information on various industry-facing programmes at the CSIR, visit the following link: Industry Innovation Support | CSIR
 

Q. What process does the CSIR follow if an individual or potential industry partner wants to express interest in obtaining a licence for a technology developed by the CSIR?
 

A. A company that or entrepreneur who is interested in licensing a CSIR technology should contact the CSIR Business Development and Commercialisation Office or the relevant commercialisation manager in the business cluster of interest. Contact details can be found here.
The potential licensee will then be provided with information about the technology, where necessary, under a non-disclosure agreement. The potential licensee will then be required to submit a business plan outlining the commercialisation strategy and the company’s resources to accomplish that plan. Once it has been established that a licensing agreement could be mutually beneficial to the parties, licence negotiations will begin in earnest – the first milestone being a non-binding term sheet.

A further evaluation period may be required by one or both parties. This includes due diligence of the potential licensee by the CSIR and evaluation of the technology by the potential licensee for a set period to determine its viability and value to the company.

The CSIR may charge a fee for granting the company the right to exercise its option to license the technology after expiry of the option period.
 

Q. What was the biggest hurdle in fast-tracking the Covid-19 diagnostic kits project?
 

A. Rapidly developing and demonstrating a manufacturing process, including the formulation of reagents in a format that meets the standards of a medical device is a challenging task. The major hurdles were the short timeframe within which the kit had to be delivered; and importing critical raw materials in the middle of a global pandemic, which saw imports and exports negatively impacted. This was further exacerbated by the restrictions that were in place.

Q. What does the South African Health Products Regulatory Authority certification mean for CapeBio? 
 

A. The licence granted to CapeBio gives the company permission to manufacture the kit as a medical device in its facility.

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