SMALL MOLECULE PRODUCT & PROCESS DEVELOPMENT

smal molecule

Computational Product and Process Design (CPPD) – To complement and advance our experimentation and manufacturing processes with computational tools, including translating drug molecular structures to material properties in silico. Some of the areas of interest include in silico design & screening of synthetic pathways and structure-based stability prediction.

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.

Portable, Continuous, Miniature and Modular Development and Manufacturing Equipment – Design and development of fit-for-purpose, small footprint, plug-and-play (modular) processing platforms, for drug product and API that allow the same equipment to be used for development and commercial manufacturing. Desired state is for processing modules to be capable of manufacturing multiple products at a wide range of scales and enable significant reduction in scale-up and technology transfer efforts.

Innovative Chemical Synthesis – Development of new platform syntheses that include sustainable/“green” chemical technologies and innovative chemical transformations. Partnerships in the areas of replacement of endangered metal catalysts and general methods for catalytic preparation of chiral amines are desired.

Drug Delivery Technologies – Advanced drug delivery technologies to enable differentiated therapies and the next generation of precision medicine. Specific areas of interest include:

  • Novel parenteral solubilization and delivery approaches
  • Membrane permeability-enhancing drug delivery platforms
  • Differentiated pediatric dosage forms (ideally solids-based) that mask, neutralize or improve taste without affecting the pharmacokinetics for oral immediate-release products

Advanced Analytical Technologies – Innovative analytical platforms to enable real-time process understanding and/or control via on-line or at-line technology for Drug Product and API. Specific areas of interest include:

  • Process Analytical Technologies (PAT) and sensor technology for advanced process control
  • Microfluidic sample handling platforms compatible with continuous manufacturing processes
  • Miniaturized, robust separation sciences platforms
  • 3-D mapping/imaging of drug products