Combination Product Industry News & Guidance

Case Study:

When a global pharmaceutical company began planning test strategies for a new novel combination product, the complexity quickly became apparent. Teams weren’t aligned, and leadership couldn’t get the clarity they needed to make fast, confident decisions. Sound familiar?

A large pharmaceutical company with global operations was in the process of developing a novel combination product and needed expert support in evaluating test methods critical to the success of their program. Their primary goal was to define appropriate test methods for the novel delivery device that would be in full alignment with regulatory and clinical requirements.

The project objective centered on assessing existing methods and delivering a comprehensive strategy for test method selection, validation, and implementation specific to a novel device-based combination product. However, several challenges surfaced. The client team had limited functional knowledge of test method requirements for such novel and complex combination products. Additionally, the existing test plans lacked proper alignment with regulatory expectations, which significantly hampered progress.

These challenges led to a number of observed impacts. The client faced prolonged decision-making timelines due to uncertainty around test method strategy. There were notable gaps in readiness for regulatory review, and potential inefficiencies in validation planning became evident. These factors collectively increased the risk of development bottlenecks and posed a serious threat of a delayed product launch due to a potentially unsuccessful regulatory submission.

Upon deeper engagement, Suttons Creek discovered that the client’s internal documentation did not incorporate risk analysis to guide test method selection and validation. There was also a noticeable misalignment between regulatory, quality, and technical teams regarding expectations and requirements for test design. Internal stakeholders were unclear about how to link risk analysis with test method justification, and the organization lacked standard operating procedures for test methods that would define sampling, validation, and development requirements.

To address these issues, Suttons Creek delivered a detailed, risk-based strategy for the test methods needed across the design, development, and manufacturing phases. They facilitated engagement within the client’s Analytical team to establish alignment on test method procedures and sampling plans, thereby maximizing testing efficiency. Additionally, Suttons Creek provided a roadmap for validation activities that were fully aligned with the combination product’s regulatory submission and commercialization needs.

By unifying the client’s approach across functions, Suttons Creek accelerated decision-making, reduced ambiguity, and laid a strong foundation for effective regulatory engagement.

AUTHOR

Albana Thorpe, Director Technical Services, Suttons Creek – Albana has over 16 years of experience in the Medical Device and Combination Product industries at multiple global companies, including West Pharmaceuticals and Bard Peripheral Vascular. She has hands on experience in Development, Engineering, Manufacturing Process Development and Program Management for various types of medical devices and combination products (on-body injectors, pre-filled syringes, and implantable products).With a passion for meeting patients’ needs, she blends her development and program management background to drive excellence in execution.