Chemical Process Technologies (CPT): Giant Leap for Local Manufacturing as CPT Celebrates Milestone

In June 2018, Dr Hannes Malan – Managing Director of South Africa’s Chemical Process Technologies (CPT) – told Enterprise Africa that the company was formulating a plan to expand into the manufacture of medicines for human use. Founded in 2001, already an expert in the manufacture and production of active pharmaceutical ingredients (APIs) for use in the animal health and research industries among others, the company established CPT Pharma with support from the Industrial Development Corporation (IDC) and the Technology Innovation Agency (TIA), an entity of the Department of Science and Innovation. The goal for CPT Pharma has always been to react to the opportunity of import replacement of APIs.  

APIs are the component in a medicine which provide the medical benefit. For many years, South Africa has been a mass importer of API’s with as much as 90% of APIs used in 2018 coming from foreign markets (mainly China and India). APIs make up 50-60% of the total manufacturing cost, so producing API’s in South Africa provides major benefits.

 In 2015, CPT Pharma broke ground on a pilot plant to prove that APIs could be successfully produced locally on a commercial scale. Construction of the pilot plant was completed in 2017 and CPT Pharma has since received Good Manufacturing Practice (GMP) approval by the South African Health Products Regulatory Authority (SAHPRA) for the manufacturing of four APIs.

 “CPT Pharma was identified as an ideal partner for TIA’s intentions to support development and commercialisation of technologies to enable local API manufacturing. The success to date has also positioned the company as a key partner in ongoing collaboration initiatives within the National System of Innovation to stimulate the local pharmaceutical industry,” says Dr Vuyisile Phehane, Executive: Bio-economy at TIA.

 FULLY LICENCED

 In August, CPT announced that it had achieved a major milestone when it was granted a licence by the SAHPRA to manufacture APIs for human medicine.

 “We are honoured as a company at being able to take the lead in advancing the South African pharmaceutical industry through obtaining this licence. While we appreciate the milestone, we acknowledge that there’s still a lot of work to be done in this space,” says Dr Malan.

 Initially, the company will focus on proofing the in-house developed technology for four APIs before expanding the plant to semi-commercial production capacity. Two of the APIs are used in the treatment of tuberculosis, and one is used for the treatment of epilepsy as well as neuropathic pain.

 Financial Director, Anton Steyl tells Enterprise Africa that obtaining this licence is an impressive coup for the business, and will help catapult it to the top of the health manufacturing industry on the continent.

 “Our audit and receipt of the license makes us one of only two companies on the continent that can manufacture active pharmaceutical ingredients for medicines. This means we have the go ahead to register the drug master files.

 “Two years ago, we had opened the plant after construction. From then until now, we have been commissioning and installing all of the equipment and making sure everything works.

It’s been a long journey to get here but we finally have the licence and we are very happy,” he says.

 The next stage in the company’s development involves partnering closely with customers to ensure products are of the highest standard and perfect for their intended markets.

 “We now need to undertake stability tests and prove that the products we are making are within the required qualities before we hand over to our customers who will also perform stability tests and incorporate into their drug master file before we can start full production. We are still around two years away from full production but the biggest hurdle of gaining the license is now out of the way,” says Steyl.

 JUMPING HOOPS

 CPT will continue its work with animal health products and, currently exporting various products to more than 15 countries across five continents, the hope is that the CPT reputation of reliability and world-class quality will spread. With minimal interruption over the past two years, the company has performed exceptionally well during the build up to audit and has successfully overcome all hurdles.

 “One of the things we found while working through the process was the massive amount of documentation requirement – I think we underestimated that,” admits Steyl. “The processes that you need to have in place are tremendous.

 “We’ve been able to solve all of the challenges we’ve faced, and we continue to learn as we go. The next and more commercial phase of the plant will hopefully go even better and quicker.”

 Understandably, the Covid-19 pandemic has thrust a spotlight on those in the pharmaceutical manufacturing industry. With demand for inoculations far outstripping supply, the large multinationals involved in the development of novel vaccines have been redirecting all resources to research and development, and involving smaller local players in supply of existing, ongoing demands in the market is vital.

 “The decision in 2012 by CPT to get involved in the local manufacturing of APIs has been validated by the onset of the Covid pandemic which emphasised the dependence of the world on geographically concentrated pharmaceutical manufacturers in the East. Having our facility GMP approved is a major achievement for the company and confirmation that we are well on our way to achieving what we set out to do in 2012,” says Dr Malan.

 “Local production of APIs not only shortens the supply chain for local pharmaceutical companies but also provides more sustainable access to medicines since it eases the industry’s reliance on imports for critical products. Moreover, it opens up a whole new sector for employment growth and skills development in the country,” adds Nelis Geyer, Acting Head of Industry Planning and Project Development at the IDC.

 Dr Gerrit van der Klashorst, Director of Business Development at CPT, is also keen on developing a local industry: “We believe there is a major opportunity to establish a local API manufacturing industry in South Africa. We import more than R20 billion worth of APIs and need to start by replacing imports with locally produced material. The manufacturing technology must be world competitive and requires contemporary and locally developed solutions,” he says.

 COVID RESILIENT

 Like all companies, CPT has had to adjust during the pandemic. New working patterns and a quickly changing environment has meant the business had to be nimble.

 “During the harsh lockdown, CPT Pharma was offline and then we spent a considerable amount of time and energy getting our processes Covid resilient and thinking about how we would deal with outbreaks,” details Steyl. “We adjusted how we do things to take the virus into account. CPT is in the food supply industry and was classified as an essential service and we had all personnel that were not physically required on the premises working from home. We worked out a different shift system for those that had to be in the factory to optimise working safely and healthily.”

 Fortunately, the company has weathered the Covid storm well and has not been forced to close or reduce output. Also, the agricultural industry in which CPT supplies has been largely uninterrupted and enquiries have continued to roll in.

 “The agricultural industry in South Africa has been doing very well this year so there has been no shortage of orders. The only way we were negatively affected was during the period where India was in lockdown and getting raw materials became more difficult,” says Steyl.

 He is confident that going forward, the business can continue to solve problems and remain relevant while others continue to deal with medium-term fall out.

 “Business has been impacted around the world. It has accelerated the movement towards flexibility around working from home for employees that can do their duties in that manner. I don’t think working from home will be a permanent fixture but there will be a hybrid model going froward. At the end of the day, businesses are quite resilient but there are those that will not make it and that will leave spaces for new businesses to grow into. Each business has a function and if your function has not disappeared then the demand will remain. Businesses that can best satisfy that demand will thrive. We are seeing very strong orders coming in and that gives us confidence.”

 At HQ in Waltloo, Pretoria, CPT is buoyant following its licence win – a perfect antidote after months of general business negativity. There is no doubt that this innovative organisation is one to watch and will continue to be a shining light for South Africa.

 “We have a very strong and very experienced management team with input at non-executive directorship level from the IDC for CPT Pharma. We have executed well over the past two years and now is a very exciting time for the company,” concludes Steyl.