Pharmaceutical: Advancements Add To API Development

May 10, 2019
Using biocatalysis instead of traditional chemistry can dramatically simplify the operational aspects of the transformation process.

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.

Sponsored Recommendations

Keys to Improving Safety in Chemical Processes (PDF)

Many facilities handle dangerous processes and products on a daily basis. Keeping everything under control demands well-trained people working with the best equipment.

Comprehensive Compressed Air Assessments: The 5-Step Process

A comprehensive compressed air audit will identify energy savings in an air system. This paper defines the 5 steps necessary for an effective air audit.

Get Hands-On Training in Emerson's Interactive Plant Environment

Enhance the training experience and increase retention by training hands-on in Emerson's Interactive Plant Environment. Build skills here so you have them where and when it matters...

Managing and Reducing Methane Emission in Upstream Oil & Gas

Measurement Instrumentation for reducing emissions, improving efficiency and ensuring safety.