🔍 This method includes assessing system limitations, process conditions, performance, and non-performance factors.
📊 The aim is to optimize filtration methods like hollow fiber and flat-sheet cassettes for improved production outcomes.
💡 Comparing various factors ensures better therapeutic manufacturing efficiency.
Introduction:
The article discusses the critical role of tangential flow filtration (TFF) in bioprocessing, emphasizing the necessity for a systematic approach to select the best TFF format tailored for specific therapies. This approach aims to streamline the production of biotherapeutics, particularly in complex applications like gene therapy and monoclonal antibody production.
- A diverse range of TFF formats exists, with hollow fiber (HF) and flat-sheet (FS) modules commonly utilized for large molecules in bioprocessing, although optimal formats for certain therapies remain undetermined.
- The systematic four-step approach developed by McCarney and colleagues includes evaluating system limitations, process and membrane conditions, performance metrics, and non-performance factors such as cost and scalability.
- The methodology was applied in producing adeno-associated viruses (AAV5 and AAV8) using human embryonic kidney cell lines, revealing the influence of TFF method on various production aspects.
- Comparison across multiple factors is essential for effective optimization, as highlighted by the study’s findings, which underscored that TFF method choice impacts certain production characteristics but not all.
- McCarney’s team’s approach provides a broad roadmap for comparing TFF formats, stressing the importance of considering various objectives beyond mere performance in the design of bioprocesses.
Conclusion:
The article underscores the necessity of a structured methodology in selecting TFF formats for biotherapeutic production. As the landscape of therapies evolves, optimizing bioprocessing through tailored filtration strategies will be crucial, highlighting the need for future research to refine and expand these approaches in various therapeutic applications.
