Dealing with Challenging APIs

News
Video

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].”

Click above to watch the full interview

About the speaker

Jens Schmidt is the Associate Director of Manufacturing, Science, and Technology (MSAT) at Lonza.

Jens Schmidt is the Associate Director of Manufacturing, Science, and Technology (MSAT) at Lonza.

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.

Recent Videos
Roger Viney from ICE Pharma discusses the quality and compliance issues surrounding the use of animal-derived ingredients in the bio/pharma industry.
Tore Bergsteiner from MAIN5 discusses the most pertinent and impactful bio/pharma industry trends from 2024.
Simon Wright from Almac Pharma Services chats about shifting demand for commercial manufacturing services and how service providers are adapting to meet demand.
Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Miguel Forte from ISCT and Kiji Therapeutics chats about expectations for 2025 and the future technology agenda for industry.
Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.