Towards a common framework for defining ancillary material quality across the development spectrum.

Area of Science:

• Biotechnology and Pharmaceutical Manufacturing
• Regulatory Science

Background:

• Ancillary materials (AMs) are critical for cell and gene therapy manufacturing, as final products often cannot be sterilized.
• Current guidance emphasizes a risk-based approach to AM quality management and supply chain risk, but harmonization is needed.

Purpose of the Study:

• To propose a novel, staged approach to ancillary material quality management in cell and gene therapy development.
• To balance risk mitigation with cost of goods containment throughout the AM lifecycle.
• To facilitate communication between AM suppliers, users, and regulators.

Main Methods:

• Development of a heuristic framework for a staged approach to AM quality.
• Analysis of risk-based principles for AM qualification and supply chain management.
• Consideration of current Good Manufacturing Practice (cGMP) compliance requirements.

Main Results:

• A staged quality framework is proposed to manage AMs effectively.
• The approach aims to reduce development and manufacturing costs.
• The framework is designed to lessen the burden of regulatory compliance.

Conclusions:

• Implementing a staged approach to AM quality can optimize the manufacture of advanced therapy medicinal products.
• Balancing quality, cost, and regulatory compliance is achievable through a harmonized, risk-based strategy.
• The proposed framework supports efficient and compliant AM sourcing and utilization.