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

Dr. Jörg Mohr: It is essential to already identify cost drivers in the bidding process and to envision optimized processes without having developed them in the lab yet. Our process development concept is based on three main pillars. We use design of experiments — DOE — to optimize reaction conditions. Second, our automated mini-plant equipment resembles the plant-scale equipment as closely as possible to shorten development time. Third, we operate a well-equipped process technology lab to closely monitor reaction kinetics and to investigate process safety conditions.

“Speed, technology and knowledge
of complex chemistry are becoming
more important as competitive differentiators.”

Dr. Jörg Mohr,
Head of Process Development & Analytics,
Saltigo

Quality by Design — QbD — and process analytical technology — PAT — play an important role in our compliance system. At-line and online analytics, in particular, are becoming more and more popular, and classical in-process controls are being replaced by PAT. We believe the combination of online/at-line analytics with release procedures is a future trend. QbD, a well-established methodology in the pharmaceuticals industry, is gaining importance in other industries as well.

In addition to established programs, we are carefully observing which new software developments are available to the industry. For example, we tested ChemPlanner and found it to be helpful when the objective is to generate new synthesis ideas. However, that is only a sideline of our activity because Saltigo, whose essential activity is process development, generally has to use manufacturing processes — technical packages — specified by its customers.

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

Dr. Jörg Mohr:Ž We see that the types of compounds being developed are becoming more complex and the total number getting to market is diminishing; therefore speed, technology and knowledge of complex chemistry are becoming more important as competitive differentiators.

Our team’s know-how makes a major contribution to minimizing scale-up risk, for example. An inherent problem in scaling up a project from the laboratory scale to production is physical in nature. While a mixing process on the laboratory scale frequently takes only a few seconds, the length of time it takes in the reactor is significantly longer and cannot simply be extrapolated to the larger production quantity. The same goes for the effects on process safety. Therefore, we are using a modeling tool for optimizing and predicting the performance of batch process unit operations and a process modeling software  for distillation modeling — not least to ensure safe operation.