Genetic Engineering & Biotechnology News

MAY15 2018

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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Don't despair. Instead, find out what the leading mass spectrometry (MS) mechanics are doing to boost the resolving power of their machines. After a little time under the hood, you may decide that you're ready to shift your basic research, drug development, or qual- ity control projects into high gear. Recent innovations include isotopically calibrated spectral analysis software, instrumentation to detect metals within individual cells, and methods to label the entire metabolome to facilitate inter-laboratory com- parisons. These innovations, and many others, will be presented at the 66th American Society for Mass Spec- trometry (ASMS) Conference on Mass Spectrometry and Allied Topics, which will take place June 3–7 in San Diego. In the meantime, we invite you to watch some powerful MS systems as they take a few qualify- ing laps in this feature article. Finding Impurities and Degradants High-resolution instruments provide formula identification through accurate mass analysis. How- ever, in routine quality control of pharmaceuticals, it would be more economical and practical if the iden- tification of unknowns could also be accomplished on a more common, cost-effective instrument, such as a single quadrupole LC–MS instrument. In their usual role as chromatography detectors, single quad- rupole LC–MS instruments deliver nominal mass or unit mass resolution. They do not provide accurate mass analysis. An MS measurement is not a single line for a giv- en ion but a unique isotopic fingerprint whose pat- tern is unique for every formula. But the imperfect "electromagnetic lens" of an MS instrument pro- duces imperfect line shapes. Ion measurements taken at various times on the same or different instruments will not yield, upon analy- sis, identical fingerprints. Moreover, each biosimilar may go its own way, pursu- ing whatever developmental or marketing goals its li- cense holder may have in mind. Although they have many opportunities to deviate from predrawn regulatory, marketing, and prescription paths, biosimilars may be heading in the right direction. For example, "highly similar" biologics may start fol- lowing procedures for establishing their interchange- ability with their reference products, as well as with each other. Herding biologic copycats over a shifting regulatory and pharmacy practice landscape won't be easy, but a roundup has already com- menced, as evidenced by the see page 22 see page 10 MaryAnn Labant Even if your trusty old mass spectrometer is firing on all cylinders, it may seem under- powered, particularly if you're trying to run down impurities, degradants, elemental markers, metabolites, and other elusive species. You may even feel as if your better equipped colleagues are preparing to pass you by. Mass Spec Is Being Souped Up to Help It Keep Up Managing Biosimilars Is Like Herding Copycats Richard A. Stein, M.D., Ph.D. Biosimilars, or copycats of biologic drugs, stray from clearly defined categories. Each biosimilar comes from a unique bio- manufacturing environment and, consequently, possesses unique chemical attributes, which may or may not prove to be clinically relevant—most likely not (but worth checking). I N T H I S I S S U E The Scoop St. Jude to Build a Collab-Fostering Research Hub 6 G E N R O U N D U P Bioprocess Filtration Adjusts for Smooth Flows 16 Biosimilars Market $4.49 billion 2017 2023 $23.63 billion Source: (CAGR 31.7%) With Digital PCR, the Rare Becomes Routine 12 T U T O R I A L Optimizing Circular Dichroism Spectroscopy 20 May 15, 2018 When cellular uptake of cisplatin, a platinum-containing chemotherapeutic, is evaluated with inductively coupled plasma- mass spectrometry (ICP-MS), measurements of platinum concentration pertain to cell populations. In studies of cisplatin uptake in ovarian cancer cells, Single Cell ICP-MS (SC-ICP-MS), a technique developed by PerkinElmer, has been used to measure platinum at the level of individual cells. SC-ICP-MS can scan for any metal in cells ranging from 0.2 to 100 μm in size.

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