Navigating the Solid-Form Landscape: From High-Throughput Screening to Robust Crystallization Processes

Selecting the right solid form and developing a robust crystallization process are critical steps in pharmaceutical development. This webinar explores how high-throughput solid-form screening and data-driven process development can be combined to efficiently navigate complex crystallization landscapes and identify conditions that deliver the desired solid form, purity, and product quality.

High-throughput screening enables a broad experimental space to be explored using relatively small amounts of material. Depending on the development question, this may include polymorph, salt and cocrystal screening, as well as systematic evaluation of crystallization solvents and process conditions. The resulting knowledge supports solid-form selection and provides a strong foundation for subsequent crystallization process development.

Once a suitable solid form has been selected, experimental strategies can be further used to develop a robust crystallization process that controls the solid form outcome and realizes impurity rejection. Statistical approaches such as Design of Experiments (DoE) can be used at this stage to efficiently investigate interactions between parameters and define an appropriate operating space.

This webinar illustrates this integrated approach using the purification of oxcarbazepine from the structurally related impurity carbamazepine as a case study. High-throughput experimentation is used to efficiently investigate crystallization conditions, followed by more focused experimentation to understand the key parameters governing purification performance. A DoE approach demonstrates how experimental data can subsequently be translated into process understanding and used to identify optimal operating conditions.
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Key Topics:‍

• Solid-form selection: Building understanding of the solid-state landscape to select the most appropriate form for development.
• High-throughput screening: Rapidly exploring solvents, crystallization conditions, solid forms and purification opportunities using limited material.
• Crystallization process development: Translating screening results into robust and scalable crystallization strategies.
• Purification through crystallization: Understanding how crystallization conditions influence the rejection of structurally related impurities.
• Data-driven process understanding: Using focused experimentation, including DoE where appropriate, to identify critical parameters and define suitable operating conditions.
• Case study: Purification of oxcarbazepine from carbamazepine as an example of moving from screening to targeted process optimization.

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