Small Molecule Product & Process Development

WRD is interested in establishing alliances to develop and access:

• Computational Product and Process Design (CPPD) — Complement and advance our experimentation and manufacturing processes with computational tools, including translating drug molecular structures to material properties in silico. Specific areas of interest include:
  • Computational models for process operations
  • Prediction of oral absorption in humans
  • Computational Chromatography
  • Multi-scale integrated modeling platform technologies for Systems-based Pharmaceutics predictions and simulations
  • In silico design and screening of API synthetic pathways
• Materials Sciences and Particle Engineering — Development of molecular structure-based particle design and engineering tools that allow for the prediction and manipulation of crystal form/morphology, solid-state stability and material properties. Specific areas of interest include:
  • Computational Materials Science for particle engineering
  • Solid State Chemical Stability Prediction and Control
  • Delivery of API ensuring physical integrity during ensuing process operations
  • Particle engineering through directed assembly
• Portable, Continuous, Miniaturized and Modular Manufacturing Equipment — Design and development of fit-for-purpose, small footprint, plug-and-play (modular) platforms, drug product and/or API development, and manufacturing equipment. Continuous/semi-continuous operation and rapid deployment are cornerstone concepts that are being pursued. Desired state is for processing modules to be capable of manufacturing multiple products at a wide range of manufacturing scales and enabling significant reduction in scale-up/tech transfer efforts.
• Innovative and Chemical Synthesis — Development of new platform syntheses that include sustainable/"green" chemical technologies and innovative chemical transformations. Specific areas of interest include:
  • Replacement of endangered metal catalysts
  • General methods for catalytic preparation of chiral amines
  • General methods for "direct" amide formation
• Drug Delivery Technologies — Advance drug delivery technologies to enable differentiated therapies and the next generation of precision medicine. Specific areas of interest include:
  • Drug targeting to improve therapeutic index (e.g., brain delivery, tumor targeting)
  • Differentiated pediatric dosage forms that 1) improve taste without affecting the pharmacokinetics for oral immediate-release products, 2) use a "solids-based" platform (versus conventional liquids), and/or 3) use innovative dosing aids
• Rapid Analytics — Innovative analytical platforms to enable real-time process understanding and/or control via on-line or at-line technology for Drug Product and Active Pharmaceutical Ingredients (API). Specific areas of interest include:
  • Enhanced and integrated in-situ Process Analytical Technologies (PAT) for routine process monitoring.