Comprehensive screening services
To support API solid state research & development (SSRD) programs, Eurofins CDMO offers a comprehensive array of screening services. We apply High-Throughput Screening Technology (HTST) for expeditious discovery of new polymorphs, pharmaceutical salts, solvates, co-crystals, particle size engineering and development or automated crystallization scale-up development.
Polymorph Screening
Salt or Co-Salt Screening
Solubility & Dissolution Services
Polymorph screening
Comprehensive polymorphism studies are IP enabling and also crucial for NDA filling. Through Eurofins CDMO’s polymorph screening services, we investigate isolation and crystallization of the API in a number of solvents with different properties and under a variety of conditions to identify and characterize new solid forms (polymorph, hydrate, solvate) and to understand the relationship between them. Our routine polymorph screening employs several crystallization techniques including:
- Slurry
- Cooling
- Anti-solvent addition
- Evaporation
- Grinding
Our flexible screening designs can be tailored to the Client’s needs based on which phase of the development they are focused on and what are their concerns and limitations. Utilizing High-Throughput Screening (HTS) technologies is cost effective. Our routine screening requires minimum amount of API while performing a large number of crystallization experiments (384 experiments per run) resulting a significant reduction in cost.
Salt or Co-Crystal Screening
Salt and co-crystal screening are reliable solutions in modern drug development to address challenges such as low solubility, chemical instability and high hygroscopicity in APIs. Utilizing High-Throughput Screening (HTS) technologies, we investigate formation of salts/co-crystals with pharmaceutically acceptable salt and co-formers in different solvent mixtures. This screening approach provides us with a quick identification of lead candidates which then will be prepared for complete characterization.
Solubility and Intrinsic Dissolution Screening
Starting materials, intermediates and API’s solubility are essential information required to optimize different steps of a manufacturing process. Utilizing high-throughput robotic technology and in-house analytical capabilities, our fast and accurate solubility screenings occur in a large number of solvents while using minimum quantity of material and solvents. Solubility and dissolution are also key parameters that control rate and extent of drug absorption and its bioavailability. Our miniaturized disk IDR apparatus from Pion can produce highly reproducible intrinsic dissolution results using in situ fiber optic UV measurements. Through the solubility and intrinsic dissolution studies, potential bioavailability challenges of a compound can be identified far earlier during the development of new chemical entities, which could help our clients to reach their critical decision point faster.
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