🔍 Researchers argue traditional methods are limited and resource-intensive.
💡 By using mechanistic models, the new protocol predicts contamination without extensive practical testing.
🧪 This method incorporates factors like adsorption and dilution, enhancing product safety while being cost-effective.
Introduction:
The article discusses the growing necessity for effective leachability analysis of single-use systems (SUS) within the pharmaceutical industry, particularly focusing on the contamination risks posed by leachables—trace chemicals that can affect product quality and patient safety. Researchers from Johannes Gutenberg University introduce a simulation-based methodology aimed at enhancing leachability assessments while reducing resource expenditure.
- Current leachability testing methods are resource-intensive and limited to isolated unit steps, potentially missing dynamic interactions within biomanufacturing processes.
- Leachables can directly impact drug quality, process efficiency, and patient safety, necessitating thorough risk assessments.
- The proposed simulation-based approach integrates factors like liquid partitioning, device geometry, and operational parameters, conferring a more comprehensive analysis of leachables.
- By coupling mechanistic models with dynamic tracking through process flowsheets, the new protocol can predict contamination scenarios without extensive practical testing.
- This innovative method not only reduces costs but also enables manufacturers to focus on critical conditions and low-risk processes, thus improving overall safety and efficiency in biomanufacturing.
Conclusion:
The adoption of simulation-based protocols for assessing single-use system leachability represents a significant advancement in biomanufacturing safety and efficiency. By overcoming the limitations of traditional testing methods, this approach promises to enhance product quality and patient safety while streamlining operational processes. Future research can expand on these simulations to establish standardized practices across the industry.
