Solid Form Services

The selection of a lead solid form of an API is a critical step in early pharmaceutical development. Determining the most suitable chemical and physical form impacts a range of critical parameters including manufacturability, stability and bioavailability. The selection of a lead solid involves the screening and characterization of chemical forms (free form, salts, hydrates, solvates and cocrystals) and polymorphs and/or amophous forms  Every molecule is different with varying propensity for polymorphism and the formation of hydrates and solvates. Additionally, the physicochemical properties of the molecule and the target product profile will determine the need for screening salts, cocrystals or bioavailability-enhanced formulations. These properties will also determine solubility, dissolution rate and/or manufacturability of any solid form.

Our solid form services are designed for flexibility, and can be readily accessed alone or part of an integrated drug substance and/or drug product development program. These services can be rapidly advanced into crystallization development studies, leveraging Lonza’s extensive infrastructure and expertise in advanced chemical synthesis. Solid form screening and identification are also a core component of our SimpliFiH® Solutions first-in-human services, consisting of integrated and phase-appropriate development of API and drug product and designed for accelerated timelines.

Defined work with customizationLonza solid form services are built on a foundation of API characterization, materials science and problem statement analyses core to our API development and bioavailability-enhancement service portfolios. In-house equipment and expertise is in place to rapidly understand the solid form landscape of your molecule. Example screens typically performed by our Solid Form Services team include:

• Characterization
• Primary polymorph screen
• Stable form screen
• Stable form developability assessment
• Primary salt screen
• ASAP and traditional stability
• Enantiomeric screening
• Single crystal XRD
• Secondary salt screen
• Salt developability assessment
• Cocrystal screen
• Secondary polymorph screen
• Preformulation screen
• Hydrate mapping
• PXRD method development
• Amorphous solid dispersions