Despite tremendous challenges facing the pharmaceutical industry, it continues with its commitment to innovation and the discovery of novel drugs to address unmet medical needs. Indeed, medicinal chemists face a challenge of their own. Trying to survive in a changing environment where pharma is focusing on biologics drug candidates will require chemists to adapt.

CHEManager International asked R&D experts of chemical and pharmaceutical companies to elaborate on their research strategy and share their opinion with our readers. In detail, we interviewed professionals ranging from CEOs to heads of R&D and process development about:

The crucial success factors in chemical and pharmaceutical research.

Andreas Stolle:ΠFor a process development chemist in the pharmaceutical industry, speed and flexibility are of utmost importance when considering the supply of drug substance to clinical development. This not only requires experienced chemists but also the ability to combine chemistry and chemical engineering for manufacturing and scale-up.

“Speed and flexibility
are of utmost importance
when considering the supply
of drug substance to clinical development.”

Andreas Stolle,
Vice President,
API Process Development Services,
Patheon

Modern laboratory tools are designed to support this challenge with parallel experimentation and fast — preferably online — analytical methods. Seamless collaborations — internally and externally — with plant engineering, quality organizations and health-safety-environment departments are also essential.

The role of information technology tools in developing reaction routes and processes.

Andreas Stolle: Databases for literature, chemical reactions, retro syntheses and properties of chemicals are well-established in the industry. However, for the design of synthetic routes, we strongly believe that a brainstorming exercise of chemists and process engineers remains critical to quickly consider scalability and specific plant features and supply chains.

The usage of design of experiment — DOE — software is vital to simplify and accelerate modern process development, and create more knowledge about critical process parameters.

Challenges and changes affecting the work of R&D chemists in the future.

Andreas Stolle: ŽWith approximately 40% of newly developed APIs being classified as complex molecules, manufacturing is no longer a straightforward task. While timelines are expected to be even shorter, APIs now have a larger number of stereo centers, more labile functional groups, longer synthetic pathways and also require unusual reaction conditions.

As a result, conventional pharmaceutical manufacturing equipment may not always cope with this growing synthetic complexity. The task of the chemist goes beyond traditional chemistry and a synthetic route, and an innovative plant concept needs to be co-developed. Only this approach will allow a service provider to deliver high-quality material and a sustainable production concept, which allows for prolonged patent protection by the client.