Case Study

Risk-based Test Method Strategy

The Situation

Company: Global Pharma with primary operations in the United States developing therapies for serious diseases with high unmet medical needs.

Issue: Client desired evaluation of test methods for new implantable device-biologic combination product to ensure readiness for development testing and lot release testing.

Project: Suttons Creek was hired to evaluate test methods for implantable device-biologic combination product considering sampling plan, procedures, fixturing, and how to maximize testing efficiency. The end-objective was to define appropriate test methods for their novel delivery device, in alignment with regulatory and clinical requirements.

Challenges Expressed:

 

  • The team had limited functional knowledge of test method requirements specific to novel and complex combination products across different phases of the product lifecycle
  • Existing test plans lacked alignment with regulatory expectations

Impact:

  • Prolonged decision-making timelines regarding test method strategy
  • Gaps in readiness for regulatory review
  • Potential inefficiencies in validation planning
  • Risk of delayed launch due to development bottlenecks and unsuccessful regulatory submission

Discovery:

  • The client’s internal documentation lacked integration of risk analysis to inform the selection and validation of test methods
  • There was misalignment between regulatory, quality, and technical teams on expectations and test design requirements
  • Internal stakeholders were uncertain about how to connect risk analysis with test method justification
  • Lack of Test Method SOP’s outlining requirements for sampling, validation and development

Solutions Implemented:

  • Delivered a detailed, risk-based strategy for test methods required in design, development, and manufacturing phases.
  • Facilitated engagement within the Analytical team to align on test method procedures and sampling plans to maximize testing efficiency.
  • Provided a roadmap for validation activities aligned to their 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 the groundwork for efficient regulatory engagement.