Together, our world-class strengths in hazardous chemistry, large-scale manufacturing, and the application of diazomethane allow us to uncover new opportunities for our customers that enhance manufacturing efficiency and success while continuing to place safety first.
Diazomethane manufacturing at Sterling
Diazomethane holds significant potential for API development and manufacturing as it provides key advantages like versatility and efficiency. Diazomethane’s extremely hazardous and sensitive nature has prevented it from reaching widespread use in large-scale pharmaceutical manufacturing.
At Sterling, we have dedicated years of work to developing an approach that enables us to successfully harness diazomethane in API manufacturing in a safe and scalable way. We utilise a process for diazomethane development and generation that balances safety and cost-effectiveness. Our diazomethane precursor is significantly less hazardous than common alternatives, and can be stored under ambient temperature and pressure for more than six months. Today, we are one of only a handful of western cGMP manufacturers utilising diazomethane in API manufacturing. Our expertise and state-of-the-art equipment allow us to safely carry out diazomethane reactions at the 100 kilogram scale. ... Read more
Following are some of the things that enable us to safely apply diazomethane:
- Strength in hazardous chemistry: We combine our process engineering, chemistry expertise, and hazard evaluation experience to ensure the safety of diazomethane chemistry.
- Specialised equipment: We utilise state-of-the-art equipment designed specifically for enhancing our diazomethane understanding and capabilities.
- Robust data: Our hazard evaluation work has enabled us to generate a highly accurate and up-to-date diazomethane data set and profile.
- Unique expertise: Sterling is one of only a few western cGMP manufacturers leveraging diazomethane in API manufacturing.Read less
Key Benefits
When safely applied, diazomethane can deliver significant benefits in pharmaceutical manufacturing.
These include:
Versatility:
As a mild compound, diazomethane does not require harsh conditions and offers versatility in manufacturing.
Efficiency:
Diazomethane’s inherent versatility has the potential to enhance the efficiency of process development and optimisation.
Enhancing safety:
Continuous generation and immediate consumption allow generation to be carefully matched to the kinetics of the substrate and ultimately keep inventory low.
A robust approach to hazard evaluation
Our work in diazomethane is supported by our comprehensive and proven hazard evaluation methodology and long track record of handling hazardous chemistry. We apply more than 50 years’ experience working with hazardous processes and compounds to ensure the proper controls are in place for every project, prioritising safety while maximising efficiency and scalability.
“While diazomethane is extremely hazardous and challenging to handle safely, it provides significant advantages in API development and manufacturing. We apply our hazardous chemistry and hazard evaluation experience to utilise diazomethane in our customers’ projects, enabling them to realise its benefits while ensuring the utmost safety.
” Ben Moffatt | Hazard Evaluation Scientist
