CrystalMax® Process Flow
Unique, high-throughput technology. Talented scientists may envision thousands of worthwhile crystallization experiments, but time and materials typically limit even the most productive worker to performing only a fraction of them. TransForm has developed proprietary technology and informatics to overcome these limitations. Our highly integrated and automated CrystalMax® system enables us to perform over 10,000 parallel crystallization experiments, on one or multiple Active Pharmaceuticals Ingredients (APIs), within 2 weeks, exploring a broad diversity of solvent combinations, process conditions and other variables, using just a few grams of material.
Informatics-driven. Sophisticated design of experiment software enables TransForm scientists to design unique crystallization experiments for each API based on chemical structure, quantity available, past experimental results, and goals of the project. Our informatics systems track every sample as it is dispensed, processed, and analyzed. We then expand on interesting leads to design and execute additional experiments as appropriate.
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Flexibility. Identifying crystalline forms is challenging. Our scientists employ many different process modes for inducing crystallization, including:
|Thermal crystallization||Thermal microscopy|
|Controlled evaporation||Sitting drop crystallization|
|Vapor infusion||Gel crystallization|
A further strength of our CrystalMax® platform is that, unlike conventional plate-based crystallization systems, in which all experiments must be harvested simultaneously, our unique system enables our scientists to remove and analyze individual samples containing solids at any time, while experiments that have not yet yielded crystals can be given more time or subjected to additional processing steps. This minimizes waste and enables us to work with smaller amounts of API, in a far more flexible manner, than commercially available systems. We can work with as little as 250µg per experiment.
Analysis. We employ the latest technologies to analyze and characterize the crystals that we discover, including high-throughput Raman spectroscopy, high-throughput PXRD, DSC, TGA and thermal microscopy. Where appropriate, we can also quickly rank all solid forms that we discover according to solubility, thermodynamic stability and/or hygroscopicity, in order to assist our partners in selecting the optimal form for development.
Broad applicability. Our advanced crystallization capabilities enable us to rapidly and comprehensively discover unusual solid forms that may be of commercial importance to the drug:
|Because they improve the performance of the drug (Case Study)|
|Because they enable a new manufacturing process or delivery system, or|
|Because they may be used to supplement (or circumvent) patents on a particular, preferred solid form of the drug.
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Ongoing improvement. At Transform, our scientists, engineers, and software designers communicate continuously to add new capabilities and increased flexibility to our CrystalMax® crystallization technologies and the informatics that power them.