Crystallization Development From Screening to Kilogram Supply Brochure

A crystallization process for a non-specified pharmaceutical drug substanceAs the bulk properties of a drug substance can have enormous impact on the downstream processing properties (filterability, dryability, flowability) or formulation (bulk density, impurities), the development of a robust and scalable crystallization process is an essential step in drug development.A crystallization process is also the most frequently used technique for purifying solid drug substances. Irrespective of whether the chemical or chiral purity needs to be enhanced, a specially designed crystallization process is the best choice for processing.Solvias offers a seamless approach to design and optimize a robust and scalable crystallization process together with kilogram supply of API under GMP, if required.Crystallization DevelopmentFrom Screening to Kilogram SupplyPolymorphism InvestigationForm Selection& Process DesignCrystallizationProcessOptimizationMultigram to Kilogram Supply(GMP/non-GMP)Amazing where you can goSolvias AGRömerpark 24303 KaiseraugstSwitzerland Tel. +41 61 845 60 00 Fax +41 61 845 69 00info@solvias.comwww.solvias.comPolymorphism Investigation• Determination of relevant polymorphic forms• Evaluation of polymorphic transformations• Identification of thermodynamic most stable form• Identification of hydrates and solvatesForm Selection & Process Design• Determination of temperature-dependent solubility of relevant polymorphs• Identification of metastable zone width• Evaluation of different crystallization techniques (cooling, seeding, addition of antisolvent, pH shift, salt formation, azeotropic distillation)• Variation of solvent systems (solvent quality, solvent class)• Determination of proper stirring time and speed• Assessment of changes in substrate concentration• Process development in terms of crystal design (size, shape)• Comprehensive analytical testing (HPLC, headspace GC, X-ray powder diffraction, particle size distribution, microscopy, etc.)Crystallization Process Optimization• Systematic variation of relevant process parameters (cooling profile, stirring profile, seeding process, spiking with impurities, water activity)• Optimization of process and bulk properties (space volume yield, batch cycle time, compression of final product, filterability)Multigram to Kilogram Supply• Proof of concept on 250g scale• Delivery of seeding crystals from gram to kilogram scale • Crystallization on kilogram scale under GMP or non-GMP• GMP release testing• Shipment of final product to customer• Technical transfer of crystallization processOur ContributionThe unique combination of Solvias expertise in solid-state chemistry, crystallization process development and kilolab production under GMP and non-GMP, supplemented with state-of-the-art instrumentation, enables us to tackle the majority of all drug development candidates. Your Process• Faster• More efficient• Safer• More cost-effective