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small-molecule-process-development-and-production
WRD Pharmaceutical Sciences envisions a network of partners to enhance active pharmaceutical ingredients (API) and drug product development and manufacturing of small molecules.

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 — Advanced drug delivery technologies to enable differentiated therapies and the next generation of precision medicine. Specific areas of interest include:
    • Tissue targeting of drugs to improve therapeutic index (e.g., brain delivery, tumor targeting, etc.) 
    • Technologies to imporve/monitor patient adherence/compliance
    • Anit-abuse and deterrence technologies 
    • Differentiated pediatric dosage forms that
      1. Neutralize or 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:
    • Rapid, precise, robust, and integrated in-situ Process Analytical Technologies (PAT) for routine process monitoring.
    • 3-D mapping/imaging of drug products
    • Real-time data integration from disparate sources
    • Predictive science of stability, including structure-based stability prediction

External R&D Innovation Contact: Paul.E.Young