Quality by Design Framework Applied to GMMA Purification.

Area of Science:

• Vaccinology
• Biopharmaceutical Manufacturing
• Quality by Design

Background:

• Generalized Modules for Membrane Antigens (GMMA) are emerging as a promising vaccine platform.
• Their manufacturing simplicity makes them particularly suitable for low- and middle-income countries.
• Robust manufacturing is crucial for vaccine efficacy and accessibility.

Purpose of the Study:

• To outline a Quality by Design (QbD) framework for GMMA manufacturing.
• To identify critical quality attributes (CQAs) and process parameters for GMMA production.
• To support the development and control of GMMA-based vaccine manufacturing processes.

Main Methods:

• Application of QbD principles to GMMA production.
• Assessment of critical quality attributes (CQAs).
• Analysis of product-process interactions and in-process analytical methods.

Main Results:

• A systematic methodology for QbD implementation in GMMA manufacturing is proposed.
• The approach facilitates the control of manufacturing processes for consistent batch characteristics.
• Initial steps of GMMA manufacturing process were analyzed using the suggested methodology.

Conclusions:

• QbD implementation is essential for robust GMMA manufacturing.
• This framework supports technical transfer, regulatory approval, and commercialization of GMMA vaccines.
• The presented methodology aids in ensuring the quality and consistency of GMMA-based vaccines.