Bridging the Gap Between Validation and Implementation of Non-Animal Veterinary Vaccine Potency Testing Methods

Area of Science:

• Biotechnology and Pharmaceutical Sciences
• Toxicology and In Vitro Assays
• Regulatory Science

Background:

• High-throughput, non-animal methods are emerging for vaccine quality control, aiming to replace, reduce, or refine animal use.
• Despite validation and slow regulatory acceptance, manufacturers are hesitant to adopt these humane alternatives.
• A gap exists between regulatory approval and industry implementation of non-animal testing methods.

Purpose of the Study:

• To develop a paradigm to expedite the implementation of validated non-animal methods in vaccine quality control.
• To narrow the gap between regulatory acceptance and industry uptake of humane alternatives.
• To provide a process for assessing local regulatory acceptance and integrating non-animal methods.

Main Methods:

• Systematic analysis of experience promoting transparent implementation of validated non-animal vaccine potency assays.
• Development of a refined paradigmatic process for industry and regulatory engagement.
• Focus on assessing local regulatory acceptance and identifying/eliminating barriers to integration.

Main Results:

• A refined paradigm has been developed to facilitate the adoption of non-animal vaccine potency assays.
• The process aids in assessing regulatory acceptance and integrating new methods into quality control protocols.
• The approach addresses peripheral barriers hindering the use of non-animal methods, especially for potency testing.

Conclusions:

• The presented paradigm offers a structured approach to accelerate the integration of validated non-animal vaccine testing methods.
• This strategy aims to overcome industry inertia and ensure broader adoption of humane alternatives in vaccine manufacturing.
• Successful implementation of this paradigm can significantly advance the use of non-animal methods in routine quality control.