Design & Simulation / Powder & Solids

Pharmaceutical: Advancements Add To API Development

Using biocatalysis instead of traditional chemistry can dramatically simplify the operational aspects of the transformation process.

By Tonia Becker, Sr. Consultant, Synthetic Biology, Life Sciences and Chemicals, Haig Barrett

Until recently, pharmaceutical active product ingredient (API) developers were limited to selecting from a roster of chemical catalysts to perform the transformations needed for drug manufacturing. However, given that there are a multitude of bases for developers’ API route decisions — including patient safety, transformation efficiency, development speed, cost, process robustness, product quality, environmental impact, process portability and manufacturing worker safety — the more options we have to achieve these goals, the better.

Additionally, API development organizations must create increasingly complex molecules for an expanding roster of novel therapeutics within shortening development timelines. New pressures and requirements call for new options. Thankfully, the industry does have a more modern catalytic option with an expanding application base: enzyme-based biocatalysts. So how did we get here?

By the late 1880s, scientists were able to systematically vary the structure of chemical substances, along with their emerging pharmacological knowledge, which enabled them to create the building blocks for today’s pharmaceutical industry. Over the decades, chemists have become quite good at using various chemical catalysts, typically metal-based, to create drug products. Although these catalysts are adequate, they do have their drawbacks, such as a higher risk of product impurities, generation of hazardous waste, less efficient processes, and new regulatory pressures.

Read the rest of this article from our sister publication Pharma Manufacturing.

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