ROCKVILLE, MD, March 14, 2024 – Today, the United States Agency for International Development (USAID) announced a partnership with a South African pharmaceutical company to transfer technology that will facilitate a more efficient and less expensive manufacturing process for a critical active pharmaceutical ingredient (API) used in the prevention and treatment of tuberculosis (TB). The USAID-funded Promoting the Quality of Medicines Plus (PQM+) program, implemented and led by USP, is helping to facilitate and support the transfer of novel technology to manufacture rifapentine API using continuous manufacturing. This represents the first-time continuous manufacturing is being used to produce API in South Africa.
“Rifapentine is a key drug in the prevention and treatment of TB,” Jude Nwokike, PQM+ program director and USP vice president, said. “This groundbreaking technology transfer will expand global access by optimizing the manufacturing process and reducing the production cost of rifapentine.”
PQM+ collaborated with Virginia Commonwealth University (VCU) to develop a new process to synthesize rifapentine API using continuous manufacturing. USAID has selected Chemical Process Technologies in South Africa to receive the technology. The new process reduces production costs related to expensive raw materials, high solvent consumption, and material waste due to process inefficiencies, while ensuring quality throughout the development process.
In addition, PQM+ will provide technical assistance to the South African Health Products Regulatory Authority (SAHPRA) to further strengthen its regulatory capacity for API review and inspection, particularly related to the oversight of pharmaceutical products developed using continuous manufacturing. If approved, this will mark the first quality-assured and commercially available source of API produced using continuous manufacturing in Africa.
The technology transfer seeks to help meet targets set by the global TB community to end TB as public health challenge by 2030. In September 2023, the United Nations held its second high-level meeting on TB, where Member States confirmed their commitment to the UN’s Sustainable Development Goals and the World Health Organization’s End TB Strategy, with targets of 45 million TB treatments and 45 million preventative treatments delivered by 2027. This technology transfer will support global efforts to increase API manufacturing and expand access to TB prevention and treatment.
USP Media Contact:
Nazila Fathi (she/her)
Email: nazila.fathi@usp.org
Phone: +1-301-816-8547
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About PQM+
The Promoting the Quality of Medicines Plus (PQM+) is a six-year cooperative agreement between the U.S. Agency for International Development (USAID) and the U.S. Pharmacopeial Convention (USP) to sustainably strengthen medical product quality assurance systems in low- and middle-income countries. PQM+ works to improve medical product quality through cross-sectoral and systems strengthening approaches and the application of international quality assurance standards across the pharmaceutical system.
About USP
USP is an independent, scientific, nonprofit organization focused on building trust in the supply of safe, quality medicines. We are working to strengthen the global supply chain so that the medicines people rely on are available when needed and work as expected. USP has 14 offices across 16 countries and has implemented global health programs in 90+ countries worldwide.