Process and economic evaluation for monoclonal antibody purification using a membrane-only process.

Area of Science:

• Biotechnology
• Bioprocess Engineering
• Separation Science

Background:

• The growing market for therapeutic monoclonal antibodies (mAbs) necessitates cost-effective production and purification methods.
• Traditional mAb purification relies on multiple chromatography steps (Protein A, IEX, HIC) and filtration, which are resource-intensive.
• Membrane adsorption/chromatography presents a potential alternative to packed bed systems for streamlining downstream processing.

Purpose of the Study:

• To evaluate the use of ultra-high capacity electrospun nanofibrous adsorption membranes as a replacement for conventional chromatographic media in mAb purification.
• To assess the economic and operational benefits of a membrane-only downstream purification process compared to traditional methods.

Main Methods:

• Process simulation using SuperPro Designer software.
• Modeling the replacement of Protein A, Ion Exchange (IEX), and Hydrophobic Interaction Chromatography (HIC) packed beds with nanofibrous membranes.
• Quantifying changes in media volume, processing time, labor, waste generation, and operating expenses.

Main Results:

• Nanofibrous membranes reduced the required volume of Protein A, IEX, and HIC media by 25%, 80%, and 80%, respectively.
• The membrane-only process decreased downstream processing time by 50% and labor hours by 40%.
• A 40% reduction in aqueous waste and a 23% decrease in overall downstream operating expenses per unit product were observed, alongside savings in facility and equipment costs.

Conclusions:

• Implementing nanofibrous adsorption membranes offers a significant improvement over traditional packed bed chromatography for mAb purification.
• The membrane-only approach is economically competitive and enables a more efficient, cost-effective, and potentially disposable downstream processing strategy.
• This technology holds promise for advancing the economic viability and operational flexibility of therapeutic mAb production.