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Reviewing the process intensification landscape through the introduction of a novel, multitiered classification for
Louis Crowley1, Paul Cashen2, Marc Noverraz2
1Sartorius Stedim North America Inc, Bohemia, New York, USA.
Biotechnology and Bioengineering
|January 12, 2024
Summary
Process intensification in biopharmaceutical manufacturing offers benefits but faces adoption challenges. This study proposes a standardized, leveled approach for implementing downstream process intensification, enabling incremental and cost-effective adoption.
Area of Science:
- Biopharmaceutical Manufacturing
- Process Engineering
- Biotechnology
Background:
- Increasing demand for biopharmaceuticals drives the need for process intensification.
- Current adoption of process intensification is hindered by complexity, cost, and unclear terminology.
- Existing literature lacks a standardized approach, causing confusion in the field.
Purpose of the Study:
- To address the challenges in adopting process intensification in biomanufacturing.
- To propose a defined, leveled approach for implementing downstream process intensification.
- To introduce standardized nomenclature for clarity and consistent application.
Main Methods:
- Comprehensive review of state-of-the-art systems and consumables.
- Analysis of current process intensification case studies in biomanufacturing.
- Development of a tiered implementation strategy with standardized terminology.
Main Results:
- A clear, standardized nomenclature for process intensification is proposed.
- Process intensification can be implemented incrementally as distinct, independent levels.
- This approach facilitates cost-effective adoption for biomanufacturers of all sizes.
Conclusions:
- The proposed leveled approach simplifies the adoption of process intensification.
- Standardized nomenclature reduces confusion and promotes consistent application.
- This strategy enables scalable and economical implementation of process intensification in biopharmaceutical production.
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