DSM promotes enzyme technology at CPhI as a solution to developing more sustainable formulations
The legacy of antibiotics is at 'serious risk' and the pharmaceutical industry must contribute to the solution by embracing sustainability, DSM Sinochem Pharmaceuticals (DSP) has warned. The company is a global player in enzymatically-produced green beta-lactam antibiotics. Karl Rotthier, DSP’s President, said the 'most important medicine known to mankind' faced a bleak future amid the rise of antimicrobial resistance, lowered production standards, and pollution by irresponsible low cost manufacturers.
Rotthier, addressing business leaders at the CPhI congress in Paris, France, said companies throughout the industry have a duty to work together to produce at the highest quality, meeting strictest standards and minimising their environmental impact. 'The solution can be summed up in one word: sustainability,' he said. 'Sustainable antibiotics are the only option for our future success – medically, economically, environmentally and ethically.'
Antibiotics are an essential medicine to mankind. 'Without antibiotics most of modern medicine becomes impossible,' said Rotthier. 'Transplant surgery is no longer possible, tuberculosis becomes incurable and pneumonia once again becomes life threatening, as would many other bacterial infections,' he added.
Sustainable antibiotics are the only option for our future success – medically, economically, environmentally and ethically
The greatest challenge is antimicrobial resistance, which is now estimated to contribute to more than 25,000 deaths every year and costs more than €1.5bn in healthcare expenses and productivity losses in Europe alone, according to The European Centre for Disease Prevention and Control. Rotthier emphasised that pharmaceutical firms could not defeat antimicrobial resistance alone, but it was crucial that the industry collectively adopted the highest production standards to prevent worsening the problem by, for example, active antibiotics being discharged into the environment.
He added: 'While we alone cannot change society, we can do our part and I deeply believe we must. Our contribution starts with a sustainable supply chain; raising the performance and compliance levels of manufacturing and production and a high quality product is essential.'
DSP is a 50/50 Joint Venture of Royal DSM, a global science-based company active in health, nutrition and materials, and Sinochem Group, a Fortune 500 enterprise. It is applying proprietary enzyme technology to pharmaceutical production.
At the CPhI show in Paris, DSP unveiled a new generation of 'eco-friendly' super-statins produced using a pioneering production method that maximises purity and cuts the environmental impact of making statins – currently the most prescribed drug class globally for high cholesterol and cardiovascular disease and one of the top-selling drugs worldwide.
DSP’s super-statins Atorvastatin and in the future Rosuvastatin are produced in-house using a unique proprietary and fully backward integrated process. At the core of this process is a highly efficient enzymatic step. This makes DSP's process not only greener, but also yields a purer API than chemically produced alternatives.
The joint venture of DSM and Sinochem will produce the super-statins Atorvastatin and Rosuvastatin using the same highly efficient and sustainable technology platform. It will also allow a FTO (Freedom to Operate) for Rosuvastatin upon patent expiry.
The super-statins are the latest addition to DSP’s portfolio of 'PureActives' – drugs made using enzymatic biotechnology. In the case of statins, the technology eliminates many harmful chemicals such as butyl-lithium and the dependency on a very limited number of ATS-8 intermediate suppliers. The technology leads to a carbon footprint 35% lower than traditional production methods, creating less waste and greater purity, which means less use of solvents. The company says superior quality also enhances the stability and allows formulators to dose more accurately.