📈 Researchers at Merck highlight that better clarification processes can enhance quality attributes (CQA) significantly.
🔍 Applying quality by design (QbD) principles helps control impurities and ensures product safety.
⚙️ The study showcases how process parameters, like centrifugation speed, relate to CQAs, promoting improved manufacturing reliability.
Introduction:
This article explores the often underestimated role of clarification processes in enhancing critical quality attributes (CQA) in biomanufacturing, emphasizing a paradigm shift that integrates quality by design (QbD) principles into these processes. Researchers from Merck propose that optimization in clarification can substantially improve both product quality and process reliability.
- The traditional view considers clarification processes as minor contributors to CQA, but Merck’s research suggests re-evaluating this assumption due to advancements in processing technology and increasing product demands.
- Quality by Design (QbD) is defined as a systematic approach that enables manufacturers to ensure predefined quality by integrating quality measures into the manufacturing process from the outset.
- Utilizing QbD in clarification processes allows for improved control over impurities, aligning operational parameters with quality targets to ensure product safety and efficacy.
- The research includes a risk assessment model that evaluates how changes in the clarification process affect the risk of leachables, thus influencing product integrity.
- By systematically applying QbD principles, critical process parameters can be optimized, enhancing the relationship between these parameters and product quality, thereby ensuring compliance with regulatory standards.
Conclusion:
The findings presented by Merck underscore the significance of incorporating QbD into clarification processes, revealing that such an approach not only elevates product quality but also streamlines manufacturing. This work encourages biomanufacturers to rethink traditional strategies and adopt integrated practices that promote regulatory compliance and product reliability throughout the entire product lifecycle.
