Solid state chemistry plays a major role in successfully developing a compound into a drug product. The physical and mechanical properties are important in selecting the most appropriate stable form with sufficient solubility. The occurrence of crystallization from a crude reaction mixture is the first step towards obtaining a pure drug substance.
For process chemists crystallization is an essential tool for isolation and purification of the compound in a robust and reproducible way. In addition, the crystallization conditions impact the crystal form or polymorph, particle habit, and its characteristics like stability and bio-availability. Optimized pharmaceutically-acceptable crystallization conditions are established by varying cooling profile and slurry conditions, by adding anti-solvent, or by applying seeding to obtain the preferred form, if needed.
The Alcami Advantage
- Controlled conditions will result in the same quality material each time. The crystallization of the desired, suitable polymorphic form allows consistent purity, stability, and diverse screenings will provide insight to those conditions to obtain that preferred form.
- Crystallization is one of the tools that supports control of the particle shape and size which determines a product’s dissolution rate, bioavailability, and how it can be formulated.
- Each crystalline form Alcami finds can be patented. You can protect not only the compound, but also each new crystalline form and its unique properties.
Alcami has its own Center of Excellence (CoE) for solid state chemistry and crystallization, which is located in its Weert, Netherlands research facilities. The CoE provides multiple services to support the selection of the preferred developable form of the compound, including crystallization, analytics, form selection screening, process design of experiment (DoE), particle habit engineering, and pre-formulation. By employing a strong collaborative approach between client, process engineer, and Alcami’s CoE, the most optimal compound form is selected for meeting a customer’s unique needs and timelines.
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Edwin Aret holds a PhD in solid state chemistry from Radboud University Nijmegen, the Netherlands. He has nearly 20 years of experience supporting every facet of the pharmaceutical development cycle, from discovery to commercialization, covering small molecules, drug substance, and drug product. Edwin’s in-depth expertise includes crystallization, form selection, stability studies, solubility determination, bioavailability, and crystal habit optimization. Edwin is currently the principal scientist for solid state chemistry at Alcami.
Bianca van Bree
Bianca van Bree earned her PhD in biomedical sciences from Maastricht University, the Netherlands. She has over six years of experience in the pharmaceutical development industry. She started her career as a molecular biology research and development scientist, and advanced into project management. Her expertise is in managing pharmaceutical ingredients and biomedical device projects from research phase to early phase clinical trials. Bianca joined Alcami in 2018 as a project manager.