Process Development

Each process is developed to obtain uniformity in each dose

With over 50 years of mixing and coating knowledge, ARx designs all processes with the intent to commercially manufacture a robust, reliable product. Employing Quality by Design (QbD) -based principles from a project’s concept phase, our process engineering and manufacturing teams define the design space and control strategy for development and scale-up.

In support of this mission, each process is designed to consider the project’s filing requirement with a strong understanding of formulation and excipients. This approach, combined with our manufacturing expertise, results in excellent content uniformity to ensure that the target potency is achieved in each unit dose. As a fully integrated partner, ARx ensures process control with in-process testing and utilizes in-house analytical testing capabilities for quick results. Our ultimate process development goal is regulatory approval and reliable commercial production with a strong focus placed on efficiencies in scale-up and yield optimization.

Process Development Milestones

  • Process Development for Registration: Placebo, feasibility, DOE’s and confirmatory production events for a justifiable registration process, considering QbD attributes and target timelines.
  • Cleaning Validation: Development of cleaning methods and associated analytical techniques to verify that chemical residues are below the acceptable limits on equipment train.
  • Phase III Clinical and Registration Batch Production: Execution of GMP production events for clinical and stability studies required for product registration.
  • Process Optimization for Commercialization: Optimization trials to maximize yields for intended commercial batch size.
  • Process Validation: Confirmation that the manufacturing process is repeatable and robust in support of commercial launch.

Quality Support