Advanced manufacturing research supports automated production of critical API
Posted: 23 January 2026 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
Study highlights potential of novel system for continuous, automated production of albuterol sulfate, an API on the US FDA’s drug shortage list.
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Researchers have successfully synthesised Salbutamol (albuterol sulfate), a bronchodilator asthma drug active pharmaceutical ingredient (API) on the FDA’s drug shortage list, by utilising a novel advanced manufacturing technology system (AMT).
The automated production process described by Gregory et al. supports the growth of generic drug production, restructuring of the API supply chain, lower drug prices and helping to prevent drug shortages for key medicines.
The AMT system is currently being constructed and incorporates a series of commercial flow chemistry platforms, in-line process analytical technologies (PATs), and in-house solutions.
It integrates a new salicylaldehyde-based synthetic pathway to complete the synthesis of albuterol sulfate within continuous-flow prototype reactor systems.
The process proposed by Gregory et al. can generate +700 doses per hour at a 1.0 mL/min basis for use in a liquid dose albuterol sulfate drug formulation. It can reach an overall solution yield of 78.4 percent when operating at a 1.0 mL/min flow rate basis, with a final isolated yield of 60.2 percent.
Batch processing is the industry standard for the full life cycle API synthesis. However, its inefficiencies have resulted in supply chain delays and chronic drug shortages for critical life-saving drugs, including albuterol sulfate.
advanced manufacturing technologies have the potential to address [imitations of batch processing], offering benefits including reduced waste [and] real-time quality control”
Beneficially, advanced manufacturing technologies have the potential to address these limitations, offering benefits including reduced waste, less hands-on processing, real-time quality control, as well as lower manufacturing costs by incorporating process intensification.
Furthermore, the team hypothesised that adding an automated laboratory filter dryer could “enable 10-fold scale-up and seamless transition between synthesis and purification submodules”.
With the candidate AMT system ongoing construction, the researchers plan to integrate an end-to-end second modular system for encapsulation of the finished drug product.
This research was published in Industrial & Engineering Chemistry Research
Related topics
Active Pharmaceutical Ingredient (API), Drug Manufacturing, Industry Insight, Manufacturing, Production, Technology, Therapeutics
