Archive for the 'Biotech' Category

New Jersey Remains Strong on the Biopharmaceutical Front

New Jersey is known to many as a pharmaceutical mecca on the international stage with several leading pharmaceutical majors headquartered and/or with operations in the state. So to say that lawmakers need to create an economic climate conducive to foster growth is an understatement.

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Scaling the Bioprocess Barricade

Rich WhitworthJust over a week ago, I decided to hop on the early train to Glasgow, Scotland, so that I might catch at least half of the 8th bioProcess UK conference, focusing on advancing next generation therapies. The meeting was held in the very fitting Glasgow Science Center and, given the strikes over public sector pensions that day, there were plenty of youngsters mingling with the crowds—the next generation of bioprocess engineers perhaps? Amazingly, presentations were delivered in the IMAX theatre—I have never seen PowerPoint slides on such a scale before—but given the eminence of some of the keynote speakers involved, it too was quite apt. Read more »

Thirty-Five Years in the Pharmaceutical Sciences and Counting

Patricia Van Arnum PharmTech editor A new year is often reason to reflect on what has occurred and to consider what the future may hold. And for 2012, Pharmaceutical Technology is doing just that. Next year will mark Pharmaceutical Technology’s 35th anniversary, and as part of a special issue to be published in July 2012, we are seeking to gain your input on what you feel have been the most noteworthy achievements in the pharmaceutical sciences and manufacturing and what future developments may shape the industry. Read more »

Fujifilm Moves Again in Biosimilars

Patricia Van Arnum PharmTech editor Fujifilm took another step in its strategy of building its biosimilars business with the announcement this week that it had reached an agreement with the biopharmaceutical company Kyowa Hakko Kiron to form a 50–50 joint venture for biosimilars. The move is the latest by Fujifilm, begun earlier this year with the acquisition of the former Merck Biomanufacturing Network, to position itself in the biosimilars market. Read more »

Biopharmaceutical Characterization in Detail

Angie Drakulich PharmTech editorBiopharmaceutical characterization—especially of unknowns—is becoming far more complex and far higher on the regulators’ radar.  Of particular interest for industry is compliance with harmonized guidelines that address FDA’s concept of a “well-characterized biological product,” which involves being able to measure and control the product’s identity, purity, impurities, potency, and concentration. Read more »

Prosperity through Biology

Erik Greb PharmTech editor

As the unemployment rate hovers around 9.1%, the federal government needs to find ways to create jobs. Congress is debating whether a tax break on repatriated money would prompt companies to hire more workers, as I mentioned last week. Meanwhile, the Obama administration is eyeing another potential means of stimulating job growth: investing in biological research. Read more »

A Step Forward to an HIV Vaccine

Patricia Van Arnum PharmTech editor The development of an HIV vaccine is an important, but difficult goal, but researchers at the Massachusetts Institute of Technology (MIT) recently reported on an important advance in this area. One challenge in developing an HIV vaccine has been the difficulty in measuring how effective a vaccine is in producing an immune response. The MIT researchers have resolved that challenge by developing a high-throughput automated assay to evaluate individual T-cell response. Read more »

Tax Breaks for Big Pharma: A Remedy for Unemployment?

Erik Greb PharmTech editorWorried about our persistently high rate of unemployment (and his bid for re-election), President Obama is urging Congress to pass portions of his jobs bill. In addition to aiding the economy, creating jobs could help reduce the number of people who are forgoing medications, which would be a boon for the pharmaceutical industry. Perhaps with this in mind, the Association of Clinical Research Organizations (ACRO) has thrown its weight behind a bill it says would create American jobs.

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New Things are Happening at USP for Biologics

Angie Drakulich PharmTech editorI’m here in Seattle at the USP Science and Standards Symposium, which is focusing on all things biologic and biotech. Representatives from a majority of the pharmacopeia’s expert panels are here, as are a few FDA officials, and industry members from around the world–some 30 countries are represented in fact. Various new approaches by USP are aiming to help industry better understand, develop, test, and manufacture biological products, including biosimilars. Read more »

Could Wild Gudgeon Be Canaries in a Coal Mine?

Erik Greb PharmTech editor

Concern about pharmaceuticals in our water supply has been in the public consciousness for a few years now. In 2009, the Environmental Protection Agency found traces of various drugs in fish caught in rivers that receive effluent from wastewater-treatment plants. The drugs were believed to come from doses that people had excreted or flushed down the toilet. In response, FDA updated its guidelines for disposing of drugs. New research, however, shows another potential source of drugs in our waterways. Read more »

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