Related Experiment Video
Updated: Jun 12, 2025
07:43
Author Spotlight: Addressing Regulatory Gaps in Molecular Studies by Quantifying Viral Vectors in Complex Matrices
Published on: July 14, 2023
1.8K
Case Studies on Changes and Proposed Process Development Approaches Reflecting Applicability of PDA Technical Report
Cristiana Campa1, Didier ClÉnet2, Jane Halpern3
1GSK.
PDA Journal of Pharmaceutical Science and Technology
|September 24, 2024
Summary
This article explains strategies for vaccine development and lifecycle management, using seven case studies to illustrate key concepts like control strategy and regulatory compliance for evolving manufacturing programs.
Area of Science:
- Vaccinology
- Pharmaceutical Manufacturing
- Regulatory Science
Background:
- Vaccines are complex products with long lifecycles requiring continuous manufacturing updates.
- Evolving regulatory expectations necessitate adaptive strategies for vaccine development and production.
Purpose of the Study:
- To provide context and practical guidance for vaccine developers and manufacturers.
- To illustrate key aspects of vaccine lifecycle management using real-world scenarios.
Main Methods:
- Discussion of PDA Technical Report No. 89 (TR 89) on vaccine development and lifecycle management.
- Analysis of seven case studies covering diverse manufacturing and development situations.
- Application of TR 89 concepts including control strategy, comparability, and regulatory considerations.
Main Results:
- Demonstration of applying TR 89 principles to specific vaccine manufacturing challenges.
- Illustrative examples of control strategy, prior knowledge, and risk-based approaches in practice.
- Guidance on leveraging pharmaceutical quality systems and ICH Q12 for lifecycle management.
Conclusions:
- Effective vaccine lifecycle management requires a robust control strategy and adherence to regulatory standards.
- Case studies highlight the practical application of risk-based approaches and comparability assessments.
- TR 89 offers a valuable framework for navigating vaccine development and managing changes throughout the product lifecycle.
Related Concept Videos
01:15Methods of Documentation VI: Case Management Model
561
The case management model is a multidisciplinary approach that involves healthcare professionals from diverse disciplines, such as physicians, nurses, therapists, social workers, and pharmacists, working collaboratively to address the various needs of patients. Each healthcare professional brings unique expertise and perspectives, contributing to a more comprehensive understanding of the patient's condition and tailoring treatment plans accordingly.
For example, a patient with a chronic...
For example, a patient with a chronic...
561
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
124
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
124