Process Development & Clinical Production

With over half a century experience in manufacturing processes, ARx accelerates timelines to commercialization.

With nearly 60 years of mixing and coating knowledge, ARx designs all processes with the intent to commercially manufacture a robust, reliable product through commercial production, packaging and serialization. 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 to commercialization.

With multiple products filed and approved, ARx designs each process to consider the project’s filing requirement and partner’s timelines with a strong understanding of equipment and processes, moving quickly through the product development process. 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. We are continuing developing new patented process technologies for enhanced API yields and drug delivery. 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 Feasibility for Pilot and Phase I Clinical Studies: ARx moves quickly, leveraging its foundational knowledge in its dosage forms to develop a process suitable for pilot and Phase I cGMP clinical production.
  • Process Development for Registration: After a successful pilot study, ARx further optimizes the process with placebo, feasibility, DOE 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 II, III Clinical and Registration Batch Production: Leveraging process expertise for execution of cGMP production events for clinical and stability studies required for product registration.
  • Process Optimization for Commercialization: Optimization and scale up trials to maximize yields for intended commercial batch size.
  • Process Validation: Ensures that manufacturing process is repeatable and robust for commercial launch.
Operator Process Development

Commercial Manufacture

Over 100 Million patch and film units produced annually

As an FDA registered manufacturer of multiple FDA approved specialty thin film and transdermal patch drug products, ARx takes a partnership approach with customers from concept to commercialization. The ultimate goal of any ARx product, whether branded or generic, is to provide long-term, stable commercial supply for our customers and enhanced well-being for patients.

We understand the flexibility required to meet market demands. Commercial production occurs in our cGMP suites that contain mixing capacity to scale by over 300x in order for the processes to progress quickly from development to registration to commercial supply.

We offer multiple GMP manufacturing lines that incorporate active pharmaceutical ingredients into dissolvable films and adhesive coatings under 21 CFR Part 211. New capabilities include finished product packaging and serialization. Production capacity is also continually monitored in consideration of market fluctuations to guarantee reliable supply. With several successful product launches, ARx has demonstrated capability in scaling commercial operations to meet customer demand with quality product.

ARx Commercial Support

  • cGMP Manufacturing Suites: FDA registered 21 CFR 211 lab and GMP production suites with ongoing expansion in production capacity and new capabilities.
  • Product Launch and Reliable Commercial Supply: Extensive capacity planning and support assure successful product launch and reliable supply, on time and in full.
  • Final Product Release and Certification: Supported by Certificate of Conformance and Certificate of Analysis for bulk roll and finished product.
  • Annual Product Review: Annual review to verify process, product performance, and quality.
  • Life Cycle Management & Next Generation Technologies: Continuously expanding dosage form capabilities to provide brand extension opportunities through specialty delivery applications.
ARx Manufacturing

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