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Dealing with Challenging APIs
Pharmaceutical Technology chats about the increasing prevalence of challenging APIs in the development pipeline and the hurdles facing formulators and manufacturers as a result of this trend with Jens Schmidt from Lonza.
Chronic illnesses and an aging global population are increasing the demand for innovative pharmaceutical products to help alleviate symptoms, prevent illness, or even provide a cure. As a result, pharmaceutical companies are investigating more complex and challenging APIs to seek out the most effective treatments for patients; however, these ingredients pose a number of development hurdles.
According to Jens Schmidt, associate director MSAT at Lonza, there are a few factors driving the trend of increasingly complex and challenging APIs entering the development pipeline. One clear driver has been the industry’s improved understanding of biological pathways, which has led to the investigation of more intricate molecular structures to target such pathways, he explains. Additionally, the desire to achieve very high selectivity while minimizing side effects, the use of multi-target drugs, and overcoming pathogen resistance are also contributing to the rising prevalence of more complex molecules being developed, Schmidt adds.
When formulating more challenging APIs, more advanced techniques and specialized solutions are required to overcome issues such as poor solubility and bioavailability, Schmidt continues. “There can be pure manufacturing challenges like flow properties. [which] are typically not so great compared to standard or smaller molecules,” he says. “So, process development is getting even more important. It's important for a smaller molecule as well, but it's more even more important for the larger molecule [drugs].”
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About the speaker
Jens Schmidt is the Associate Director of Manufacturing, Science, and Technology (MSAT) at Lonza. In this role, he leads a team of MSAT scientists and serves as the technology lead for high-throughput experimentation focused on small molecules.
Before joining Lonza in 2017, Jens gained valuable experience as a research associate at the University of Oxford and the California Institute of Technology (Caltech). He is an organic chemist by training and holds a Master of Science in Chemistry from the University of Leipzig and a PhD from the University of Hamburg.
