The analytical technique will provide additional information about product quality and stability
Lonza, a global manufacturing partner to the pharma, biotech and nutrition industries, has expanded the range of particle engineering services offered by its Monteggio (CH) site through the introduction of X-ray powder diffraction (XRPD).
This rapid analytical technique provides additional information about the polymorph and solid-state properties of active pharmaceutical ingredients (APIs).
Micronisation via jet milling is a well-established technique to control the particle size of APIs and enhance their processing, bioavailability and dissolution rates.
However, as micronisation is an energetic process and yields very fine particles, the process may also result in amorphous generation and/or polymorphic changes.
These changes can compromise the quality and stability of the product owing to the change in its physicochemical properties. Understanding the solid state of materials and identification and characterisation by appropriate analytical means are crucial in minimising stability related challenges.
The expert team at the Monteggio (CH) site uses a range of analytical techniques to investigate the solid state of crystalline materials. The addition of XRPD complements Lonza’s comprehensive analytical toolbox, allowing the generation of critical data across drug discovery, development and manufacturing. The XRPD instrument began operations in Q2 2022.
Salvatore Mercuri, Associate Director, New Product Introduction and MSAT, Lonza Monteggio, commented: “The implementation of XRPD provides additional analytical information, highlighting differences in the solid state of materials before and after micronisation, and determining whether additional processing is needed."
"The XRPD improves our ability to detect solid state changes induced by the micronisation process early in development and allows the problem to be properly addressed before the process is defined. This will ensure that our processes continue to obtain stable products suitable for further processing and formulation.”
Dirk Knapp, Site Head, Lonza Monteggio, added: “We continue to focus on improving our analytical toolbox to offer a full picture of the quality and stability of crystalline products. The expansion of our analytical capabilities in Monteggio creates a comprehensive offering that brings a multidisciplinary approach to API development and manufacturing.”