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:

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

Claudio Pozzoli:Ž Challenges derive from increasing use of flow chemistry as an alternative production method with respect to the standard one based on batch. This technique, now well-studied and adopted also at the industrial level usually coupled with design of experiment and an online monitoring system, is too far away to be fully understood.

“A solid background of
standard process chemistry …
is nowadays not enough.”

Claudio Pozzoli,
R&D Director Chemical Division,
Cerbios

Chemical complexity of new molecules is increasing; quite often they are not solid, and their purification cannot be done anymore by crystallizations — once considered an art — but by using different types of chromatographic purifications.

Another fascinating challenge derives from the possibility to increase the bioavailability of compounds that are otherwise poorly water soluble, modifying their particle size by using engineering systems of particle-size reduction alternative to the standard one. An interesting way to obtain this effect is by using supercritical fluid, such as carbon dioxide.

The manufacturing of highly potent active pharmaceutical ingredients — HPAPIs — whose market is the fastest growing segment in the pharmaceutical industry, and more specifically of antibody drug conjugates — ADCs — surely an emerging class of compounds attracting a lot of interest and investments from chemical companies, represent great challenges for R&D chemists. The handling of molecules having an occupational exposure limit at or below 10 micrograms per cubic meter of air, their conjugation with monoclonal antibodies — mAb, the necessity to perform these reactions and purifications under glove boxes are all challenges and changes for R&D chemists.

Finally, HPAPIs, ADCs, industrial chromatographic purifications and particle-size engineering are just some of the challenges Cerbios is facing with its R&D department and chemists. This trend is surely true now and I am sure will be much truer in the future. For R&D chemists these challenges mean that a solid background of standard process chemistry, knowledge of good manufacturing practice, HSE, program management, etc., acquired over years of experience and absolutely necessary are nowadays not enough.