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An impurity characterization based approach for the rapid development of integrated downstream purification
Steven M Timmick1, Nicholas Vecchiarello1, Chaz Goodwine1
1Department of Chemical and Biological Engineering, Center for Biotechnology and Interdisciplinary Studies, Rensselaer Polytechnic Institute, Troy, New York.
Biotechnology and Bioengineering
|April 22, 2018
Summary
This study introduces a novel method and in silico tool for designing purification processes for biological products. It rapidly develops effective purification strategies by analyzing impurity profiles and product retention data.
Area of Science:
- Biotechnology
- Biopharmaceutical Manufacturing
- Process Chemistry
Background:
- Developing efficient downstream purification processes for biological products is critical for manufacturing.
- Characterizing process-related impurities and optimizing purification steps remain challenging.
Purpose of the Study:
- To present a new approach for impurity characterization and an in silico tool for designing orthogonal, integrated downstream purification processes.
- To enable rapid development of robust purification strategies for biologics.
Main Methods:
- Characterization of impurities using linear salt/pH gradients on multimodal chromatography resins.
- Generation of impurity profiles via Reversed-phase ultra-performance liquid chromatography (UPLC) analysis.
- In silico analysis of impurity and product retention data to generate and rank purification sequences.
Main Results:
- A comprehensive database of impurity profiles and product retention was created.
- An in silico tool successfully generated and ranked multi-step purification sequences.
- The approach demonstrated rapid development of purification processes for human growth hormone and G-CSF.
Conclusions:
- The described approach accelerates the development of integrated downstream purification processes.
- The in silico tool provides a powerful method for designing orthogonal purification strategies.
- This method enhances the efficiency and robustness of biopharmaceutical manufacturing.
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