High-throughput process development: determination of dynamic binding capacity using microtiter filter plates filled...

Area of Science:

• Biopharmaceutical development
• Process chemistry
• Analytical chemistry

Background:

• Rising demand for biomolecule-based therapies necessitates cost reduction in R&D.
• Traditional chromatography column-based process development is time-consuming and costly.
• High-throughput techniques are crucial for efficient bioprocess development.

Purpose of the Study:

• To introduce a modern high-throughput approach for bioprocess development.
• To adapt the batch uptake principle for microtiter plate format.
• To enable faster and more economical estimation of dynamic binding capacity.

Main Methods:

• Utilizing microtiter filter plates packed with chromatography resin.
• Implementing batch uptake principle in a microtiter plate format.
• Developing two variants for qualitative and quantitative estimation of dynamic binding capacity (DBC).

Main Results:

• Demonstrated quantitative estimation of human polyclonal IgG DBC on MabSelect SuRe.
• Showcased qualitative estimation of amyloglucosidase DBC on a prototype Capto DEAE ion exchanger.
• Validated the high-throughput method's ability to reduce time and sample consumption without compromising data accuracy.

Conclusions:

• The proposed high-throughput method significantly accelerates the determination of dynamic binding capacity.
• This approach offers a more efficient alternative to traditional packed chromatography columns.
• The microtiter plate-based method maintains data accuracy while reducing R&D costs and timelines.