A methodology for the comparative evaluation of alternative bioseparation technologies

Area of Science:

• Biotechnology
• Chemical Engineering
• Process Development

Background:

• Increasing scale and product titers in cell culture processes strain downstream processing capacity.
• Packed-bed chromatography faces capacity limitations, driving the search for alternative bioseparation techniques.
• Evaluating numerous alternative technologies with varying strengths and limitations is challenging for process engineers.

Purpose of the Study:

• To present a methodology for assessing the industrial attractiveness of bioseparation technologies.
• To compare alternative bioseparation techniques against packed-bed chromatography as a reference.
• To identify promising alternatives for large-scale biomanufacturing.

Main Methods:

• Utilized a multiattribute decision making (MADM) analysis approach.
• Incorporated both quantitative and qualitative data for technology assessment.
• Included packed-bed chromatography as a benchmark for comparison.

Main Results:

• The MADM analysis evaluated the trade-offs between the strengths and weaknesses of various bioseparation alternatives.
• While most alternatives showed advantages over packed-bed chromatography, none were deemed overall industrially attractive for current large-scale manufacturing.
• The methodology provided quantitative insights into areas needing improvement for each alternative technology.

Conclusions:

• No current alternative bioseparation technology is a viable replacement for packed-bed chromatography in large-scale manufacturing.
• The developed MADM methodology can guide further technological development by highlighting key improvement areas.
• This approach aids process engineers in selecting and developing suitable bioseparation technologies for industrial applications.