One of the newest technical innovations being evaluated in the established monoclonal antibody (mAb) space is finding alternatives to the costly and sometimes inefficient resins columns that have become a standard part of the protein A chromatographic purification process.
The adoption of disposable methods is a new frontier in the protein A purification space, and our research and development team (R&D) has just finished a new paper on the topic, which was featured in BioProcess International’s April edition.
The potential of single-use purification options that emphasize economies of scale in mind can offer many advantages, including:
- Shorter timelines
- Significant cost savings for IND/clinical goals
- Decreased likelihood of operator error
The study into single-use technologies in antibody manufacturing evaluated the latest generation of membrane chromatography systems capable of high flow rates for enhanced productivity within disposable setups. The promise of these types of devices can be particularly appealing for those working on early-stage projects looking to get to the clinical stage as quickly and affordably as possible.
The AGC Bio R&D team compares the purification of mAbs from CHO cell-culture harvest using new single-use membrane devices vs. traditional resin-packed columns, highlighting a fully disposable mAb purification process based on membrane capture, and utilizing disposable materials for vessels, flow paths, and ion exchange (IEX) membrane devices.
The results showed that these single-use membrane devices achieved productivity levels ten times higher than those of standard protein A affinity columns at a small scale, and with similar productivity achieved at a manufacturing scales used in biologic drug development today. Additionally, these devices demonstrated comparable or better removal of impurities such as host-cell proteins (HCPs) and DNA.
Can single-use membrane chromatography revolutionize biopharmaceutical production? mAb-solutely!
