By VIO Chemicals
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VIO Chemicals reveals how to get best from process R&D
Zurich, Switzerland: – Swiss pharmaceutical ingredient developer and manufacturer VIO Chemicals says optimizing process R&D is becoming increasingly crucial in the industry’s battle to reduce time, costs and risk.
In an article ‘Under Pressure’ in the latest edition of the European Pharmaceutical Manufacturer magazine EPM, two VIO Chemical experts explain how to get the greatest benefits from process R&D.
VIO Chemicals’ marketing communication and scientific affairs experts, Maria Andrielou and Thanos Andreou, say pharmaceutical process research and development (R&D) has become ever more indispensable in the development of personalized medicines and innovative treatments that deal effectively with diseases.
“To make treatments widely available and accessible to patients, the pressure to demonstrate improved outcomes at lower costs is getting higher,” say the authors. This is particularly true when Europe faces increasing competition from emerging economies, such as Brazil and China1.
FOOTNOTE:1The Pharmaceutical Industry in Figures. Key Data 2017. By the European Federation of Pharmaceutical Industries and Associations (EFPIA). Sourced by the EFPIA website www.efpia.eu.
Contract research and development organisations (CDMOs) can play a critical role in helping drug makers develop competitive processes that avoid patent infringement risks and minimize time-to-market.
Process R&D can do this by devising new concepts, employing novel methodologies and using upcoming technologies that can reduce total chemical steps, ensure product quality and safety, guarantee consistent yields and delivery timelines, as well as reduce waste.
Advantage by design
Manufacturing process R&D must address a long list of interconnected requirements. These include optimal route of synthesis (ROS) selection, availability of starting materials, prior art and the intellectual property landscape, quality criteria and regulatory hurdles, chemical safety concerns, toxicity and environmental sustainability, to name only a few2.
FOOTNOTE:2Route Design in the 21st Century: The ICSYNTH Software Tool as an Idea Generator for Synthesis Prediction. Org. Process Res. Dev. 2015, 19 357-368.
“Designing competitive and IP-free ROSs as a way of controlling costs of materials and manufacturing is an endeavor of creativity and inventiveness. Meticulous work and smart allocation of resources is further required in order to demonstrate and sustain the competitive advantage, avoid patent infringement risks and still be in line with product launch timelines,” they argue.
Proper selection of raw materials can have a major impact on the overall cost of the chemical process development. “Whether it is about making drastic improvements in the properties of existing substances or developing new synthetic ones, optimal selection, sourcing, quality control and effective management of raw materials can lead to shorter, greener and scalable processes,” say the authors.
They also highlight the importance of designing seamless and sustainable manufacturing processes that can deliver “enormous benefits” in resource efficiency, product quality and competitiveness. “Improved manufacturing processes can ensure process repeatability and scalability3, as well as generating less waste and enhancing sustainability. This can be done with more efficient chemical pathways and/or catalysts, advanced process control strategies and the implementation of new reaction and separation technologies and concepts,” Andrielou and Andreou write.
FOOTNOTE:3Strategic Innovation and Research Agenda by the European Technology Platform for Sustainable Chemistry. Sourced by the SusChem website www.suschem.org.
Geography does matter
Finally, they identify the importance of geographic advantage, with many CDMOs shifting R&D units to smaller cities where “operational and workforce costs are lower, and where academic communities and high scientific output can offer fresh perspectives, stimulate new thinking and bring them closer to cutting-edge R&D solutions,” the experts conclude.
About VIO Chemicals
VIO Chemicals is a Swiss chemical company with core competencies in custom design, development and production of specialty chemicals, intermediates and Active Pharmaceutical Ingredients (APIs). Its products are used by diverse global end markets, including the world’s leading chemical, pharmaceutical, cosmetic and nutraceutical companies. VIO Chemicals R&D is dedicated to the development of cost competitive, high-quality and highly marketable products, while providing complete quality, regulatory and intellectual property support. The company is committed to the principles of sustainable use of chemistry and to its social and ethical responsibilities in all its operations. VIO Chemicals has its headquarters in Zurich. It operates in 3 countries and has sales agents in Europe, Asia and the Americas. For more information, go to www.viochemicals.com.