Two Rutgers University engineers specializing in the process of making drugs derived from living organisms created an analytical tool they expect will accelerate the discovery and production of biologic drugs that are often at the cutting edge of biomedical research.
In the cover story in the American Chemical Society journal, Analytical Chemistry, the researchers provide details about what they call an “automated toolkit” — or, more formally, the N-GLYcanyzer — and its potential to rapidly monitor drug quality during production of biologics.
While most biologics are tested at the end of the manufacturing process for quality and uniformity, the Rutgers toolkit can monitor biologics as they are being produced and enable the drugs to meet the quality compliance needs of regulatory agencies, such as the U.S. Food and Drug Administration.
“This tool allows us to monitor the biologic drug quality in near real-time during the biomanufacturing process,” author Shishir Chundawat, an associate professor in the Department of Chemical and Biochemical Engineering in the Rutgers School of Engineering, said.
Chundawat said continuous monitoring and control of biomanufacturing processes are critical to ensuring drug quality, and such advanced tools will help the industry save money by avoiding production of drug lots or batches that deviate from regulatory requirements, ultimately resulting in lower health care costs to benefit patients.
The new tool is an automated process analytical technology that employs a targeted biomolecule sensor system controlled by software. It homes in on a universal biochemical process active in most living cells called protein N-glycosylation, where proteins modify their surfaces by attaching complex sugar molecules known as glycans. The PAT system can rapidly track changes in these sugars and can detect when cellular processes go awry, such as when sugar molecules are not attached properly or incorrect sugars are attached to proteins, which directly impacts the safety and efficacy of the biologic drug.
“Our system will allow complex biologics to be produced with molecular-scale precision,” co-author Aron Gyorgypal, a doctoral candidate in the Department of Chemical and Biochemical Engineering at Rutgers who led the study, said. “Basically, we are able to check the drug’s quality rapidly, multiple times during the process to know for a fact that the biologic that is being produced is following the preferred reaction trajectory that meets both regulatory and industrial quality control expectations.”
This work was funded by the FDA because of the importance of improving manufacturing processes for biologics and “biosimilars,” generic versions of trade-name biologics, Chundawat said.
