Cost competitiveness is the key element in the market strategy of local pharmaceuticals company CPT Pharma (CPT standing for Chemical Process Technologies). The company opened its R50-million generic active pharmaceutical ingredients (APIs) pilot plant in Pretoria in early November. This is a joint project with the Industrial Development Corporation and the Technology Innovation Agency, and enjoys the support of the departments of Science and Technology and Trade and Industry, and the National Department of Health.
APIs are crucial components in the manufacture of pharmaceuticals. One or more APIs, combined with nonactive ingredients, are used to make pharmaceuticals. Hitherto, all APIs used by local pharmaceuticals companies have been imported into the country, mainly from India and China.
“To produce different chemicals, you need different technologies. So we identified the APIs we wanted to produce, and looked at the technologies used to produce them. It all depends on the chemistry of the molecule concerned. If we can’t find a better way of producing it, we won’t produce it,” explains CPT Pharma MD Dr Hannes Malan. “To be competitive, we identify the cost drivers in the synthesis of every molecule. That cost driver could be a specific intermediate product or raw material, or it could be a process step with a low yield. Once we’ve identified the cost driver, we look at alternative technologies. These can include a different raw material (so changing the synthesis route altogether), or sometimes it can be process optimisation (which involves repeating the process over and over again until we understand exactly what is happening in that process). For every molecule, we’ve got a costing model. And every change we make, we update the costing and see how we are progressing in developing a cost-competitive alternative route.”
For the immediate future, the company will use its pilot plant to produce two APIs, used in the treatment of tuberculosis. Within the next 12 months, these will be augmented with two more APIs, used in the treatment of endoparasites (intestinal parasites) in both humans and animals. These APIs will all be produced in test batches, varying in size between 5 kg and 15 kg, depending on the chemical involved. These test batches will then be used for stability tests for each of these APIs. There will also be enough material produced to supply to potential customers to use to make the actual pharmaceuticals, which, in turn, would also be subject to stability tests.
The company is currently developing another five APIs in its laboratory. They should be ready to be taken to the pilot plant when production of the test batches of the first four APIs has been completed.
Prior to starting commercial production, CPT Pharma has to be registered by its customers as a supplier. Also, its plant has to be certified by the South African Health Products Regulatory Authority (which was established in June, replacing the Medicines Control Council). The company is, as far as possible, trying to run these two processes in parallel in order to save time.
“We hope to start with the design of a commercial plant in 12 to 18 months,” reports Malan. “We have some space on our property to build a commercial plant for the first four APIs. Also, for some of the chemicals, we’re looking at the reactors in the pilot plant, which are big enough to produce commercial batches. But we can only do that once we’re certified.”