The Role Of Micronization In The Journey To Drug Product Development

By Salvatore Mercuri, Senior Process Development Scientist, Lonza

Whenever I think about particle engineering through micronization, it always strikes me that this part of the process is like finding a diamond and transforming it into a ring. The Discover group finds the diamond in the rough. In the Crystallization and Micronization steps, the diamond is cut and polished. Then the Formulators set the diamond into the ring.

Micronization is an incredibly important step of the process of transitioning a compound from that initial discovery into the clinic.

The key benefits of micronization:

• Firstly, improved bioavailability. Put simply, when a material is micronized, you are breaking it up into smaller pieces, effectively quadrupling its surface area. This allows the material to dissolve more quickly, enhancing the rate for solution, absorption, Cmax ,and improving overall exposure.
• The second benefit is to downstream processing. Material coming out of a crystallization rarely has a uniform particle size distribution. Micronization increases the material’s homogeneity before it moves on to the step where the drug product is made, leading to more uniform results.

Micronization is, essentially, the place where Drug Substance meets Drug Product.

At Lonza, we have the skills and expertise to cover the entire space. We can synthesise the API, we can conduct crystallization trials, and we can micronize the material. We can develop the formulation and deliver the supply to the clinic as well. We can even do this at a commercial scale.

Our Monteggio, Switzerland site offers world-class capabilities and enables a wide range of particle sizes and distributions to be created. We have the flexibility to meet every client's needs – and to fit every stage of the development journey, from clinical trials to commercialization.

For us, the whole journey always begins with a conversation. Whenever we start a new project with a client, we take the time to really get to know what their goals and needs are. People are at the heart of every business relationship, and that is why we are the perfect partner for everyone, from the smallest biotech company all the way through to the largest pharmaceutical businesses.

To learn more, please visit our website.