The local and international field of plant-based therapeutics and diagnostics is rapidly gaining significant momentum. Due to strong strategic collaborations, South African life science researchers and innovators are claiming their rightful seat in this space. 
This is evidenced by strong local and international progress:
- Approval of local manufacture of COVID-19 test kits produced by CapeBio and the CSIR in 2021.
- Local investments from private industry, Tautomer and 3Sixty Biopharmaceuticals, and public funding of CSIR research on plant-based therapeutics.
- AzarGen Biotechnologies being granted a formal meeting with the US Food and Drug Administration (FDA) and has received important guidance for manufacturing, pre-clinical and clinical development of their plant-made therapeutic.
- Continued development of a variety of plant-based therapeutics and diagnostics by a number of local research and development entities, including a COVID-19 virus-like particle (VLP) vaccine under development.
- Medicago Canada and GSK plc (formerly GlaxoSmithKline) announcing approval by Health Canada of COVIFENZ, for their plant-based COVID-19 vaccine in February 2022.
Based on these developments, the African Centre for Gene Technologies (ACGT), The Council for Scientific and Industrial Research (CSIR), AzarGen Biotechnologies and the South African Health Products Regulatory Authority (SAHPRA) co-hosted an alignment workshop titled Plant-based Clinical Drug Development in South Africa: Regulatory stakeholder workshop and site visit on plant-produced health products at CSIR’s main campus in Brummeria, Pretoria. The event included presentations of the research undertaken by CSIR, AzarGen and their collaborators over the past decade; followed by highly constructive discussions between researchers and regulators on how SAHPRA approaches applications received from the research, development and innovation community, with special emphasis on biological therapeutics using a plant-based bio-manufacturing platform. The day was concluded with CSIR colleagues showcasing their research facilities, inclusive of multiple expression systems; as well as equipment for manufacturing biological products at various scales.
Important recurring topics emerged:
- The local biopharmaceutical manufacturing opportunity is attractive, necessary and viable, especially with regards to elevated investment aspirations into Africa, well-established medical infrastructure and regulatory oversight.
- Production of biopharmaceuticals for low and middle income countries (LMIC) at affordable cost is paramount.
- Although SAHPRA has a wide range of specific guidelines for a wide range products, there are general similarities in the assessment of safety, efficacy and quality of each product regardless of how the product was made.
- Correct use of terminology of therapeutics based on originators (e.g. ‘follow-on’ or ‘stand-alone’).
- The advantages of each local facility to have dedicated personnel to deal with regulatory matters.
- The necessity for local facilities adhering to, or being upgraded to, current Good Manufacturing Practice (cGMP) regulations.
- The need to develop deeper local expertise in cGMP manufacturing processes and quality.
- The need to gain multiple perspectives from various players in the drug development value chain as well as to work in collaboration with the required health professionals (e.g. clinical pharmacists).
- SAHPRA are aligned to US FDA and European Medicines Agency (EMA) regulations.
- The need to engage regulators early in the process and inform them of new approaches and technologies used in the biopharmaceutical R&D process.
The ACGT wishes to thank all stakeholders for information sharing and highly constructive discussions to start aligning research initiatives and aspirations to regulatory considerations, enabling a world-class biomanufacturing and drug development capability.