Page 12 - SAMRC Annual Report 2024-2025

• Immunogenicity testing of vaccine candidates the CSSFF-SAMRC Biomanufacturing Capacity
in mice (Wits and UCT), rabbits (UCT) and, Development Programme and infrastructure
where required non-human primates (SAMRC) development through the Support for Vaccine
– immunogenicity assays are conducted by UCT Research, Development, Pilot-Scale Production
and NICD/Wits and Regulation in South Africa Programme
funded through KfW in partnership with the
• Challenge studies in hamsters and mice for
COVID and TB vaccines, respectively (UCT) DSTI. Together, these investments are aimed at
ensuring future self-sustainability in responding to
• Preclinical toxicity testing in rodents (NWU) emerging health threats.
• Manufacturing process optimization and techno-
economic analysis (CEBER, UCT) Medical Device and
Diagnostics Ecosystem
• Process development, quality assurance and
manufacture for clinical trials (Afrigen) It has been long recognized that the medical devices
sector in South Africa has enormous potential
• Clinical trials (SAMRC)
for growth in terms of both the development
• Development of microbial strains for manufacture and commercialization of novel “home-grown”
of the enzymes required for mRNA production innovations and increasing the local manufacturing
(SU Biofoundry) base. Various sector reports over the years, including

• Scaling up of production of the enzymes (CSIR one compiled by the SAMRC’s innovation team,
and Fluorobiotech). have demonstrated this potential but also revealed
remaining gaps and challenges hampering growth of
In addition to supporting the above components of the sector. The SAMRC, through the Global Health
the vaccine development value chain, the SAMRC is Innovation Accelerator (GHIA) and the Medical
supporting human capacity development through Device and Diagnostic Innovation Cluster (MeDDIC)

MEDICAL DEVICES VALUE CHAIN

SMEs, Innovators, Universities & Science Councils

Concept Proof of Prototype Device Verification &
Ideation
Development Concept Development Validation

Depiction of the medical devices value chain and ecosystem in South Africa

10 SAMRC ANNUAL REPOR T 2024-25