Agilent has another cover story! Agilent scientist Greg Staples is part of a research team working with biosimilar drugs. Their work recently made the cover of mAbs, an industry journal for antibody research and development.
Many of today’s medications are biological products made from living organisms (as opposed to chemical products made from chemical processes).
A biosimilar is a biological product that is approved for use because it is similar to another biological product that has already been approved. The biosimilar is expected to produce the same result in any given patient as the original product. As with “generic” chemical drugs, biosimilar drugs can help reduce the cost of health care by providing cheaper alternatives to expensive therapeutics.
Here’s the challenge: How do you tell that a biosimilar is actually similar enough to the original medication? Biological products tend to be larger and more complex than conventional drugs. Before a regulatory agency can approve a biosimilar drug, it has to resolve concerns about function, efficacy and safety.
Back to Agilent. Dr. Staples and the other researchers* applied a technique called 2D-LC/MS. I recently blogged about 2D-LC, but it had never before been used to compare an original drug to a biosimilar candidate. The researchers were able to achieve an extraordinary level of detail about different drug products, rapidly and in an automated fashion.
“This work is the first step toward developing a platform method to compare biosimilars,” Dr. Staples says. “This could allow customers to quickly assess and identify differences between products.”
In addition to the 1290 Infinity 2D-LC solution, equipment included Agilent biocolumns and an Agilent Accurate Mass Time-of-Flight LC/MS. The research was supported by a grant from the Agilent Technologies University Relations program.
Greg Staples is an Agilent research scientist who focuses on LC/MS and LC applications, especially in the biomedical and biopharmaceutical space.
* Other Principal Investigators in this work included Dwight Stoll, Davy Guillarme, Szabolcs Fekete and Alain Beck.
For more information go to:
- Comparison of originator and biosimilar therapeutic monoclonal antibodies using comprehensive two-dimensional liquid chromatography coupled with time-of-flight mass spectrometry
- Biosimilars: Information for Consumers (U.S. Food and Drug Administration)
- Two-Dimensional Liquid Chromatography (PDF Primer)
- Agilent 129 Infinity II 2D-LC Solution