Formulation and particle engineering process development

Manufacture and screening of proof-of-concept formulations to support IP generation and lead selection Design of experiments for process optimization and to support clinical readiness Computational modeling to define suitable package configuration(s)

• Pre-formulation studies to guide formulation technology selection
• Drug substance particle engineering: jet milling, wet milling, nanoprecipitation
• Characterization to understand and control solid-state form
Computational modeling to rationally select excipients and design formulations
Spray-drying feedstock development:
• solutions
• suspensions
• emulsions

Analytical method development and characterization

• Primary particle size by laser diffractionpient selection
• Emulsion droplet size by laser diffraction
• Control of solid state
• Dynamic light scattering
• Optical microscopy
• Physicochemical stability

Aerosol characterization

• Aerodynamic particle size by NGI / ACI
• In vitro lung dose (Alberta Idealized throat)
• Emitted dose measurement
• Delivered dose uniformity

GMP-enabling spray-drying process development

• high-efficiency collection of fine particles
• Computational modeling of spray-drying process
• Design of experiments for process optimization
• Scale-up to clinical batch size
• Production of GLP test and control articles for toxicology studies
• Expertise and hardware to enable smooth tech transfer to GMP
• Troubleshooting and continuous process improvement

Physical characterization

• X-ray powder diffraction
• Differential scanning calorimetry
• Thermogravimetric analysis
• Dynamic vapor sorption
• Karl Fischer titrimetry
• Water activity testing
• Bulk and tapped density
• Scanning electron microscopy

Physical characterization

• High-performance liquid chromatography