Lonza expands solid-state characterisation services for polymorph and solid-state properties of APIs with the addition of X-ray powder diffraction to its portfolio.
Pharmaceutical and biotechnology manufacturing company Lonza has introduced X-ray powder diffraction (XRPD) into the portfolio of services offered by its Monteggio site, expanding its range of services to include additional information about polymorph and solid-state properties of active pharmaceutical ingredients (APIs).
Micronisation, the process of reducing the average diameter of a solid material’s particles, is a common technique used in the production of APIs and chemicals to increase their efficacy as particles with reduced diameters have higher dissolution rates. However, micronisation is an energetic process and may result in amorphous generation or polymorphic changes. Such changes can compromise the quality and stability of a product as it changes the physicochemical properties. Appropriate identification and characterisation of a materials solid state is crucial when minimizing stability-related challenges. XRPD offers a non-destructive method for the characterisation of crystalline materials.
The addition of XRPD to Lonza’s Monteggio (CH) site will enhance their comprehensive analytical capabilities with the generation of critical data for drug discovery development, and manufacturing. Associate Director, New Product Introduction and MSAT, Salvator Mercuri at 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 at Lonza Monteggio, stated: “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.”