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Speeding Up Quality Control for Biologics

Accepted submission by Phoenix666 at 2017-05-22 16:15:53
Science

Drugs manufactured by living cells, also called biologics, are one of the fastest-growing segments of the pharmaceutical industry. These drugs, often antibodies or other proteins, are being used to treat cancer, arthritis, and many other diseases.

Monitoring the quality of these drugs has proven challenging, however, because protein production by living cells is much more difficult to control than the synthesis of traditional drugs. Typically these drugs consist of small organic molecules produced by a series of chemical reactions.

MIT engineers have devised a new way to analyze biologics as they are being produced [phys.org], which could lead to faster and more efficient safety tests for such drugs. The system, based on a series of nanoscale filters, could also be deployed to test drugs immediately before administering them, to ensure they haven't degraded before reaching the patient.

"Right now there is no mechanism for checking the validity of the protein postrelease," says Jongyoon Han, an MIT professor of electrical engineering and computer science. "If you have analytics that consume a very small amount of a sample but also provide critical safety information about aggregation and binding, we can think about point-of-care analytics."


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