PARTNERING TO MAKE HEALTHCARE AFFORDABLE IN SOUTH AFRICA
PILOT PLANT FACILITY WILL REDUCE THE COSTS OF PHARMACEUTICALS AND HEALTHCARE
A pilot plant facility located in Waltloo, Pretoria, could be what South Africa needs to save on the billions of rands it currently spends importing active pharmaceutical ingredients (APIs) for medicines. The cost of medical products and pharmaceuticals are contributing to the high cost of healthcare in South Africa. The country spends around R15 billion a year on imported APIs. The pilot facility, Chemical Process Technologies (CPT) Pharma, is the development vehicle established through a partnership between CPT, the Department of Science and Technology, the Industrial Development Corporation (IDC) and the Technology Innovation Agency (TIA). It was launched in November 2017 to manufacture generic APIs for the Southern African pharmaceutical industry. CPT is currently conducting pre-feasibility and feasibility studies on the development of a commercial pharmaceutical plant, which will initially manufacture two TB drugs and two animal health medicines. The prefeasibility study includes the construction of a pilot plant compliant with current Good Manufacturing Practice to scale up the production process, and the manufacture of batches for stability testing, as required for regulatory registration purposes. “The success of this pilot plant will mark a significant step in the national priorities to enable local manufacturing and job creation, while providing much needed competitively priced medication,” says Hilton Lazarus, Head of the Basic and Speciality Chemicals business unit at the IDC. Dr Gerrit van der Klashorst of CPT Pharma regards the pilot plant as an important step towards developing a full-scale commercial manufacturing plant, which will be adjacent to the pilot plant. At the launch last year he said, “Importantly, the pilot facility can fast-track the in-licensing of technologies (particularly antiretroviral APIs) that require an existing Current Good Manufacturing Practices facility before a licence agreement can be negotiated.”
The CPT group has also developed strategic relationships with the Council of Scientific and Industrial Research and several universities in the country, harnessing their capabilities in the design of new and competitive synthesis technologies for APIs. These technological networks are extremely important to add to CPT Pharma’s existing technology development capacity. Barlow Manilal, CEO of TIA, is of the opinion that the CPT Pharma project contributes to the national Bio-economy Strategy by supporting research, development and innovation in local pharmaceutical manufacturing. He believes that this is critical for enhancing South Africa’s competitiveness in the global pharmaceutical industry. The pilot facility is in the process of obtaining certification from the Medicines Control Council (MCC). The manufacture of batches of four shortlisted APIs for stability testing is expected to commence shortly. It is expected that the commercial plant will be expanded as more APIs
are registered by the MCC and accepted by clients. The CPT Pharma board plans to make the plant available for external users to assess the scale-up of their API synthesis technology, to manufacture clinical trial material, to transfer technology, and to manufacture small volumes of APIs on a commercial basis. While the platform will initially focus on chemical APIs, it could later be expanded to include biologics and biosimilars. CPT Pharma aims to play a pivotal role in the establishment of an API manufacturing industry in South Africa.
CONTACT DETAILS:
ADDRESS: Department of Science and Technology
CSIR Campus, Building no. 53 (South Gate Entrance), Meiring Naude Road, Brummeria, Pretoria
POSTAL ADDRESS: Private Bag X894, Pretoria 0001, Gauteng TEL: +27 12 843 6300