Opportunities for improvement in managing pre-PPQ biologic product knowledge.

Area of Science:

• Pharmaceutical Manufacturing
• Biologics Development
• Knowledge Management Systems

Background:

• Knowledge management (KM) is essential for maintaining biologic drug product quality throughout its lifecycle.
• Effective KM strategies are needed, particularly in the pre-Process Performance Qualification (PPQ) phase.
• Current practices may not adequately capture or leverage critical quality attribute (CQA) knowledge.

Purpose of the Study:

• To propose a structured approach for knowledge management in biologic manufacturing organizations before PPQ.
• To introduce the Critical Quality Attribute Knowledge Accessibility Maintenance Loop (CQA-KAML) concept.
• To align KM practices with regulatory expectations, such as ICH Q10.

Main Methods:

• The paper presents a conceptual framework for lifecycle knowledge management.
• It incorporates insights from a presentation at the 2024 PDA Annual conference.
• Real-time audience feedback was used to tailor KM suggestions.

Main Results:

• A novel lifecycle knowledge management concept, CQA-KAML, is introduced.
• This framework facilitates the identification and management of CQA-relevant knowledge.
• The approach aims to enhance knowledge accessibility and retention from early development stages.

Conclusions:

• Implementing the CQA-KAML can improve knowledge management for biologic drug development.
• Proactive KM before PPQ is vital for ensuring product quality and regulatory compliance.
• The CQA-KAML provides a systematic method to align with guidelines like ICH Q10.