Under pressure — how to get the best out of process R&D

Process R&D is vital in the development of pharmaceuticals and therapies yet more and more companies are being put under pressure to reduce time, costs and risk associated with process R&D to make treatments widely available and accessible to patients. In this article, Maria Andrielou, marketing & communication, and Thanos Andreou, scientific affairs, at VIO Chemicals, give their views on how to get the best out of process R&D.

Pharmaceutical process research and development (R&D) is indispensable in the development of personalised medicines and innovative treatments that deal effectively with diseases. In order to make treatments widely available and accessible to patients, the pressure to demonstrate improved outcomes at lower costs is getting higher. This is particularly true when Europe faces increasing competition from emerging economies, such as Brazil and China.1

This is where contract research and development organisations (CDMOs) can play a critical role in helping drug makers develop competitive processes without patent infringement risks and short time-to-market. But first things first…

Process R&D

Process R&D in the pharmaceutical industry has a long list of criteria that must be considered. These include optimal route of synthesis 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 few.2

Optimal process R&D is critical as it can save significant expenses for the pharmaceutical industry. How? 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.

Prior art route of synthesis (ROS)

Designing competitive and IP-free ROSs as a way of controlling costs of materials and manufacturing is an endeavour of creativity and inventiveness. It takes meticulous work and resources to demonstrate and sustain the competitive advantage, avoid patent infringement risks and still be in line with product launch timelines.

Raw materials

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.

Lean manufacturing processes

Designing seamless and sustainable manufacturing processes can deliver enormous benefits in terms of resource efficiency, product quality and competitiveness. Improved manufacturing processes can ensure process repeatability and scalability,3as well as generate less waste and enhance 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.

Geography does matter

Many CDMOs are shifting their 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.

References:

  1. The 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
  2. Route Design in the 21stCentury: The ICSYNTH Software Tool as an Idea Generator for Synthesis Prediction, Org. Process Res. Dev., 2015;19:357–368.
  3. Strategic Innovation and Research Agenda by the European Technology Platform for Sustainable Chemistry. Sourced by the SusChem website www.suschem.org