Speciality Pharmaceutical Manufacturer

Client situation

A leading specialty pharmaceutical company retained PSS to accelerate its efforts to develop a next-generation proprietary therapeutic that would have extended market exclusivity based on formulation claims of multiple Orange Book-listed patents

Project approach and techniques

  • Work with client management and outside counsel to evaluate patents/ intellectual property situation and opportunities for patent-protected exclusivity of a new formulation
  • Conduct Studies to Assess Characteristics of each formulation in terms of Solubility, pH, Stability, Cosolvent/Surfactant, Antioxidant, Chelating Agents and Other Components such as Preservatives and Viscosity Enhancers
  • Develop Prototype Formulations aligned with patents potentially suitable for listing in the FDA Orange Book involving seven mixtures and combinations of 18 different components/ingredients


PSS completed its early-stage formulation development and testing ahead of schedule and the selected formulation was advanced to Clinical Trial Manufacturing for a clinical trial …

  • Manage the production of non-cGMP material for use in animal model PK testing (e.g., pig or hairless rat)
  • Synthesize results of in vitro testing to select formulations most promising for PK testing using in-vivo animal models 
  • Recommend program for vendor to perform PK testing using in-vivo animal model multiple formulation candidates
  • Suggest how future results of in-vivo animal model testing can be used to decide whether to pursue scale-up and CTM production of one LCM candidate
  • Develop plan for cGMP manufacturer to adapt/ transfer in analytical methods, complete feasibility study, scale-up and prepare for clinical batch manufacturing
  • On-time launch of a Phase I PK study to further assess the new formulation.