I’ve been enjoying the inevitable social-media debate over whether we’re starting a new decade now or next year. Editors adore that sort of thing — but as much as I love accuracy, I must admit that I’m in the “now†camp. Welcome to the ’20s, anyway, whether or not you think that’s equivalent to “the second decade of the new millennium.†We humans love patterns and milestones, so watching the odometer tick over always brings about a sense of nostalgia…
Since the 1986 approval of the first recombinant therapeutic antibody, OKT3, biopharmaceuticals have become a large percentage of overall pharmaceutical company revenue. In 2018, sales of the top five selling recombinant proteins — Humira (adalimumab, AbbVie), Keytruda (pembrolizumab, Merck), Herceptin (trastuzumab, Genentech), Enbrel (etanercept, Amgen), and Avastin (bevacizumab, Genentech), all antibodies — totaled over US$48 billion. The compound annual growth rate (CAGR) for antibodies revenue was about 20% from 2004 to 2014. Those products include naked monoclonal antibodies (MAbs), Fc-fusion…
For many years the pharmaceutical industry was dominated by small (usually synthetic) molecules, mixed with a number of nonactive materials and encapsulated or (in the really old days) rolled into pills or pressed into tablets. Although synthesizing the active pharmaceutical ingredients (APIs), formulating the dosage forms, and analyzing the materials at every stage of a product life cycle were not always trivial activities, they were relatively straightforward. Most of the tools needed for analyzing/controlling each step of the manufacturing process…
Bioassays help drug developers determine the biological activity (potency) of their products, which has been a biopharmaceutical critical quality attribute (CQA) since long before that concept had a name. Because of their complex nature, bioassays are among of the most challenging experiments to perform reliably with dependably accurate results. Consistent assay performance requires a controlled environment and qualified reagents; skilled analysts who understand cell physiology, regulatory requirements, and the latest techniques; and assay protocols that are intelligently developed, characterized, and…
With demand for shingles vaccine Shingrix continuing to outstrip supply, GSK says there is limited opportunity for further growth until extra capacity comes online. Meanwhile, the firm is investing $564 million at its vaccine operations in Belgium For GlaxoSmithKline’s vaccine business, sales grew 21% year-on-year to £7.2 billion ($9.3 billion). The firm attributed this primarily to the growth in sales of Shringrix, its non-live, recombinant subunit vaccine for the prevention of shingles (herpes zoster). The vaccine has continually seen quarterly…
Seqirus says it is confident of supply of its newly approved cell-base influenza A (H5N1) vaccine Audenz in the case of a pandemic. The US Food and Drug Administration (FDA) gave the thumbs up to Seqirus for its vaccine Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted), making it the first adjuvanted, cell-based influenza vaccine approved to protect against influenza A (H5N1) in the event of a pandemic. Seqirus, a subsidiary of CSL Limited, is not planning to market the product…