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Related Concept Videos

Good Manufacturing Practices01:26

Good Manufacturing Practices

Good Manufacturing Practices (GMP) constitute a foundational set of guidelines that ensure the production of safe, consistent, and high-quality products, particularly in industries such as pharmaceuticals, biotechnology, and food processing. These protocols encompass all aspects of production, from the sourcing of raw materials to the final distribution of the finished product.A core pillar of GMP is stringent hygiene and sanitation across all production environments. This includes routine...

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Related Experiment Video

Updated: May 28, 2026

A Quantitative Glycomics and Proteomics Combined Purification Strategy
11:38

A Quantitative Glycomics and Proteomics Combined Purification Strategy

Published on: March 8, 2016

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Quality by Design Framework Applied to GMMA Purification.

Carlo Giannelli1, Francesca Necchi2, Elena Palmieri2

  • 1GSK Vaccines Institute for Global Health (GVGH), Via Fiorentina 1, 53100, Siena, Italy. carlo.x.giannelli@gsk.com.

The AAPS Journal
|March 8, 2024
PubMed
Summary
This summary is machine-generated.

Generalized Modules for Membrane Antigens (GMMA) offer a simple manufacturing approach for vaccines against bacterial pathogens. Implementing a quality by design framework ensures consistent production for global health initiatives.

Keywords:
Generalized Modules for Membrane Antigens (GMMA)manufacturingquality by designultrafiltration

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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.