1. Can displacement chromatography be used for the production scale purification of antibody (Is it an alternative to using Protein A)?
---Cation exchange displacement chromatography has been done on antibodies using our displacers. Displacement as alternative to Protein A work has been done by Lonza in Europe and a patent is filed.
2. What is the merit & cost cutting compared with the Protein A?
The price of Protein A is one expense that is less when using displacement but also the elimination of charge variants and the ability to load at higher levels translate into an overall cost savings. One of the key benefits of displacement chromatography is that displacement helps putting light into the science of mAb production. By detecting charge variants previously unknown in a substance, you can then determine whether these trace components found in a lab-scale process have the potential to impact the efficacy of your therapeutic when produced commercially. There is a huge risk elimination factor associated with this knowledge.
3. What data and real-world examples are available for scientists for further research on displacement?
---The isolation and elimination of product related impurities has been published by Genentech. (Genentech's recent papers: Isolation and Characterization of therapeutic antibody charge variants using displacement chromatography and Charge variants in IgG1: Isolation, characterization, in vitro binding properties and pharmacokinetics in rats.
Simply put, if you are purifying Monoclonal antibodies for therapeutic use, you cannot afford to ignore displacement chromatography using SACHEM EXPELL™-SP for protein purification or ISOLIS™-SP for trace component detection. It is the best approach.
You might also find the following post interesting: Three reasons why we believe in Displacement Chromatography