Technology Demonstration and Feasibility

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Technology Demonstration and Feasibility 1

The Focus and Expertise to Perfect Formulation and Development

The quality and experience of our scientists – most with a background in “Big Pharma” – gives us the ability to deploy innovative solutions at a cadence unrivaled in the CRO sector.

Most CROs can use spray drying to generate amorphous material, but we can use it to generate nanoparticles, coated particles, inhalable particles and more!

Unlike big CDMOs, we have the focus and expertise to perfect the formulation and development processes through extensive measurement of the material properties of the drug substances themselves, often making API even more rugged and reliable than the original requirements!

This ability to manipulate API properties on a “boutique” basis gives us a lot of advantages, including the ability to supply data rich submissions for eventual FDA approval.

Enabling Technologies to Improve Powder Flowability

  • Co-Precipitation Technology (CPT)
  • Adsorption
  • Moisture Activated Dry Granulation (MADG)
  • Dry/Wet Granulation
  • Hot Melt Extrusion (HME)
  • Spray Drying (SD)
  • Dry Particle Coating

Enabling Technologies to Improve Solubility and/or Dissolution

  • Amorphous by Spray Drying (SD)
  • Amorphous by Precipitation
  • Amorphous by Adsorption
  • Nano-Particles
  • Co-Processing
  • Hot Melt Extrusion
  • Solubilized formulation

Continuous Process Evaluation

  • Powder Characterization
  • Unit Operation Testing
  • Equipment Modeling
  • Process Train Modeling
  • Implementation Strategy
  • Regulatory Strategy

Enabling Technology Equipment