Vaccine Analytical Development & Product Characterisation

Situation: Critical Analytical Development Challenge

A major multinational pharmaceutical organisation faced the critical need to finalise its vaccine analytical package ahead of a pivotal Phase III clinical trial. Their challenge included:

• Assay Readiness: Rapidly developing, optimising, and validating robust and reliable assays for bulk drug substance and drug product release and stability testing.
• Product Insight: Requiring a comprehensive product characterisation package to gain deeper insight into the vaccine’s mechanism of action (MoA) and to define Critical Quality Attributes (CQAs) essential for regulatory filing and process understanding.

GRA Involvement: Expert Analytical Consulting and Oversight

GreyRigge Associates (GRA) provided specialised, end-to-end consulting to de-risk the analytical phase and ensure regulatory compliance. Our involvement focused on leveraging our deep industry expertise and experience:

• Strategic Assay Advisory: Defining the required suite of biopharmaceutical analytical assays necessary for vaccine development and regulatory submission.
• Robustness & Reliability: Ensuring all analytical methods were robust and reliable through rigorous development and pre-validation activities.
• Validation Management: Providing expert oversight and technical guidance for the successful validation of release, stability, and in-process assays for both bulk and drug products.
• Comprehensive Characterisation: Orchestrating the generation of a complete and in-depth vaccine product characterisation package to support CQA definition and MoA understanding.

Value Added: Delivering Phase III and Commercial Readiness

GRA's agile and expert intervention delivered tangible, high-value outcomes, demonstrating our authoritativeness and building the client's trust:

• Optimised Analytical Suite: Successfully supported the identification, development, and optimisation of all required release, stability, and in-process assays.
• Method Optimisation Leadership: Led Design of Experiments (DoE) approaches for the critical optimisation of a plaque-based potency assay, significantly improving its performance and reliability.
• Commercial Scale Success: Oversaw the successful validation of all analytical methods at a commercial launch scale CDMO, ensuring scalability and regulatory compliance.
• Successful Regulatory Submission: Generated a comprehensive product characterisation package that was successfully submitted to regulatory agencies, providing the necessary product understanding to fully support Phase III clinical trials and subsequent process validation.

Click here to read the client’s comments about GRA and our successful partnership.