Overview

BioDuro provides complete CMC services for small molecule products from pre-formulation through clinical supply. Our pre-formulation solutions incorporate chemical and physical characterization with biological characterization such as Caco-2 permeability and small animal DMPK.  Supported by integrated project management, our extensive pre-formulation program elucidates candidate attributes to drive decision making in formulation development, helping predict the best formulation approach.

BioDuro Advantage

• Critical mass of pre-formulation capabilities across BioDuro facilities
• Integration with PK studies
• Enabling data-driven drug development using milligrams of API

Services

Our studies determine physical, chemical and biological properties of candidate drug substances to aid in the determination of the optimal formulation path for the candidate. Testing for this includes:

• Aqueous solubility (neutral, pH dependent)
• Thermal stability
• Thermal properties (Tg, MP)
• Polymorph screening
• Structure verification
• Solvent/oil solubility
• Partitioning (logP, logD)
• Permeability measurement (Caco-2, PAMPA)
• Excipient compatibility
• Particle size, shape and crystallinity

Capabilities

Our state-of-the-art technologies include:

• Thermal analysis: TGA, DSC, mDSC
• FTIR
• Polarized-light microscopy
• Particle-size determination by laser light diffraction
• Permeability estimation by PAMPA
• Cell monolayer permeability (CACO-2)
• X-ray diffraction (powder diffraction, single crystal)
• Electron microscopy