SSPI Screening and Crystallization Services

SSPI workflows have been developed by combining fundamentals of crystallization and solid form science with years of experience and high throughput techniques. For more details on workflows, please contact us.

Services for Early Phase Pharmaceuticals

Polymorph Screening

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FAST-MORPHTM
Identifies the most stable and most viable polymorph for development as a drug candidate.

Salt Screening and Selection

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FAST-SALTTM
Rapidly identifies a viable salt with minimum number of experiments. This helps discovery scientists to produce a workable salt in precilinical phases where the lead candidate has not been selected.

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OPTIM-SALTTM
Identifies the most viable salt for development as a drug candidate. This in-depth workflow is specificto the molecular structure of the drug substance.

Crystal Formation

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CRYSTAL-ITTM
Finds a crystalline state for drug substances which are amorphous and difficult to crystallize.

Chiral Resolution

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RESOLTM
Chiral resolution through salt screening.

Crystallization Process Development

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CRYS-DEVTM
Crystallization process development which produces the right polymorph. Resolving crystallization challenges such as oiling out, stickiness, etc.

Services for Late Phase Pharmaceuticals

Polymorph Screening

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MAX-MORPHTM
Identifies maximum number of polymorphs including the most stable and most viable polymorph. Provides extended IP coverage for the drug candidate.

Co-Crystal Screening

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COFORM-IPTM
Discovers the co-crystals of a drug substance. This is a combination of molecular descriptor calculations and experimental work. The discovered co-crystals extend the IP protection of the drug substance and can result in higher bioavailability and improved properties for the API.

Crystallization Engineering

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CRYS-ENGTM
Engineers a process with controlled supersaturation that results in specific particle size distribution and morphology. Resolve drug product flowability issues by modifying drug substance physical properties. This workflow requires integrated PAT tools that monitors the supersaturation and particle size in real time and manipulates the rate of supersaturation release by changing the cooling rate or addition rate.

Equipment

The following equipment will be used to generate and characterize samples.

  • EasyMax 402

  • Multi-well crystallization blocks

  • X-ray Powder Diffractometer (XRPD)

  • Differential Scanning Calorimetry (DSC)

  • Thermal Gravimetric Analysis (TGA)

  • Polarized Microscope with Camera

  • Raman Microscope and FT-Raman Spectrometer

  • Dynamic Vapor Sorption (DVS)

  • Particle Size Analyzer

  • High Performance Liquid Chromatography (HPLC)

  • Liquid NMR

  • Solid State NMR

  • Scanning Electron Microscope (SEM)