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Tech Intelligence


by Mike May AL


AL from discovery through human studies


In the pharmaceutical industry, accurately identifying the components of a mixture can be the difference between life and death. Mass spectrom- etry delivers that capability and more. According to Jonathan L. Josephs, director, pharma/biopharma, life sciences mass spectrometry at Thermo Fisher Scientific (San Jose, Calif.), “Mass spectrometry plays many key roles in the pharmaceutical industry, from the very early stages of drug discovery through to late-stage development and clinical trials.” Looking for a biomarker to target a particular disease pathway? Mass spec might be just what you need. “When new therapeutic agents are first ‘synthesized,’ be they small molecules or large proteins, their structural composition must be determined/confirmed,” says Josephs. “Mass spectrometry plays a key role in these determinations.” Want to see how a compound impacts a pathway? MS again. The technology is used in so many aspects of the pharmaceutical process that it’s hard to name them all.


MS can reveal a compound’s efficacy and toxicology. It can be used to study a compound’s pharmacokinetics—its distribution in the body over time. “The unique degree of sensitivity and selectivity in complex matrices that is afforded by mass spectrometry makes it the technique of choice for these extensive experiments that take place from drug discovery, where animal studies are conducted, through clinical trials, where these parameters are determined in humans,” Josephs says. The technique can


also disclose if a drug causes health problems or is broken down into compounds that do.


After a drug is tested and approved, companies use MS to make sure that a manufacturing process makes the right compound and that dangerous chemicals from packaging don’t end up in the drug.


Minding the mass MS platforms used for pharmaceutical work fall into one of two categories:


nominal mass and accurate mass. A nominal mass spectrometer measures isotopes in the sample to about 1 Dalton, while an accurate mass spec- trometer measures Daltons to 3–4 decimal places. For less demanding applications, accurate mass is not required.


Nominal MS, says Diane Diehl, director of small molecule pharmaceutical marketing at Waters (Milford, Mass.), “spans the range of drug discovery and development.” In drug discovery, medicinal chemists use nominal MS to make sure they are synthesizing the right molecules. “Our ACQUITY QDa mass detector can be used here,” Diehl says. Pharmaceutical scientists also use this single-quadrupole MS technology in drug development to check for impurities in a synthesized compound.


by author


Pharmaceutical Mass Spectrometry This technology improves the entire drug cycle—


Various drugs, such as the cancer drug Trastuzumab shown here, can be analyzed with mass spectrometry. (Image courtesy of Thermo Fisher Scientific.)


AMERICAN LABORATORY 20


At the Waters mass spectrometry headquarters (Wilmslow, U.K.), chem- ists work with quadrupole time-of-flight platforms in a customer demon- stration lab. (Image courtesy of Waters.)


APRIL 2016


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