OVERVIEW

Catalent Benefits      Catalent Capabilities

Each solid-state form of an API has unique physicochemical properties that can have a profound impact on bioavailability, stability, and manufacturability. By discovering and characterizing their diversity of solid-state forms, it becomes possible to select an optimal form that displays an appropriate balance of properties that is critical for successful preclinical evaluation and product development, as well as robust manufacturing processes.

Identification of the optimal solid-state form for development relies on several factors:

• A clear understanding of the target attributes of the API and drug product
• Design and execution of an appropriate screen to produce solid-state forms of importance
• Detailed evaluation of relevant solid-state forms
• Assessment of the risk-benefit profile of the candidate solid-state forms against the target attributes.

Catalent has recently introduced OptiForm® API – a state-of-the-art solid-form screening service that can efficiently and effectively address all of these objectives. It combines industry-proven workflows and an experienced scientific workforce with high-throughput platform technologies to provide customers with a rapid and material-efficient route to solid-form discovery and selection.

We stand behind our industry expertise, platform, technologies, and screening workflows to provide you with the OptiForm® API guarantee. Bring us your compound, and we will identify the most stable crystalline form.

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CATALENT BENEFITS

• API screening platform that will help you speed your development and optimization of drug molecules
• Developed and refined over the past ten years with GSK
• High throughput platform for salt, crystal-form, and co-crystal screening
• Applied to more than 500 compounds, spanning from early-stage lead compounds through launched products
• Provided by a team of diverse and experienced scientists

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CATALENT CAPABILITIES

• Salt form discovery
  • HT screening capabilities
  • Scale-up capabilities (up to 1L)
  • Preformulation expertise
• Crystal form discovery
  • HT screening capabilities
  • Focused and comprehensive scope
  • Stability relationship assessment
• Co-crystal discovery
  • HT screening capabilities
  • Extensive library of reagents
  • Crystal-engineering expertise
• Crystallization of Amorphous
  • HT screening capabilities
  • Extensive array of diversity elements
• Problem solving
  • Characterization/identification of new phases
  • Phase quantitation
  • Contaminant analysis
• Broad analytical capabilities