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Manufacture Small Molecules, Formulation

From Brick Dust to Blockbuster

This article was published in our sister publication, The Small Molecule Manufacturer, which celebrates the field of small molecule drug development and manufacturing with interviews and articles focusing on success stories, equipment, and new processing techniques. Read more about The Small Molecule Manufacturer here.

The small molecule drug development landscape is changing. The number of complex, highly potent compounds taken to clinical trials and market is increasing, largely driven by biopharma oncology and immunology portfolios (1). Furthermore, smaller companies drive much of the innovation – not only in taking molecules to the clinic, but also to commercialization – although they usually lack the “bricks and mortar” necessary to bring a compound to market alone (2). Additionally because of the breakthrough designations, many molecules successful in the clinic follow accelerated timelines. This can put additional pressure on defining the supply chain to meet product timing. Finally, many new products, whether they are first-in-class or fast-followers, face uncertain market demand once approved, which leads to difficulties in forecasting market uptake and peak market demand.

Figure 3. Abiraterone acetate plotted on a solubility-lipophilicity guidance map.

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About the Author

David K. Lyon

Senior Research Fellow at Lonza, Bend, Oregon, USA

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