Testing Featured Articles
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ILC Therapeutics' Interferon Alpha 14 Joins The COVID-19 Fight
5/5/2020
The Glasgow-based emerging biopharma recently tapped veteran biotech leader Alan Walker as CEO as it moves ahead with two therapeutic candidates, an rIFN alpha14 focused on early-stage COVID-19 infection and a tick-derived Evasin targeting late-stage COVID-19 ARDS patients.
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New Podcast: Building Blocks Of The Biopharma Business
4/21/2020
We just launched the first full episode of the Business of Biotech podcast, a series purpose-built for the leaders of new and emerging biopharma companies. Here’s a recap of the first episode with industry icon Allan Shaw, highlighting the season to come and offering some strategic, straightforward advice for new biopharma leaders.
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CDER-ETP: A Resource For Innovative Biopharma Firms
1/15/2020
The FDA’s Center for Drug Evaluation and Research’s Emerging Technology Program (CDER-ETP), is yet another step toward removing slow-moving bureaucracy and red tape that stands in the way of innovative new technologies that drive drug development.
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Staying On Top Of Microbes: Smarter Testing Technology For Labs Of The Future
4/15/2015
Over the past decade, drug and medical device manufacturers have become leaner and more stream-lined. Given the current market pressures, companies are looking for more ways to improve their bottom-line.
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Pilgrim Software's 10th Global Customer Conference Lauds 'Success Through Quality'
4/23/2014
Pilgrim Software, Inc., a leading provider of cloud and on-premise enterprise quality management solutions, hosted its tenth worldwide customer conference this month.
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BioOutsource Opens New Facility In Cambridge, Massachusetts
4/23/2013
BioOutsource Ltd. (“BioOutsource”), a global leader in the biological analysis of biosimilar molecules for the biopharmaceutical industry, today announced the opening of a new facility in Cambridge, Massachusetts, the company’s first in the United States.
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BioReliance Acquires Rights To Big Blue Colonies And Cell Lines From Agilent
3/7/2013
Sigma-Aldrich Corporation recently announced that BioReliance, the biologics and early development services business under SAFC, has signed an agreement to acquire the colonies required for the Big Blue transgenic rodent mutation (TRM) assay and to obtain a license to its associated trademark from Agilent Technologies.
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Implementing A Systemic Approach To Pharmaceutical Quality Systems
1/3/2013
In 2002, the Food and Drug Administration (FDA) announced an initiative to integrate quality systems and risk management approaches into existing regulations for pharmaceutical manufacturing. While the FDA hasn’t changed the 21 Code of Federal Regulations (CFR) Parts 210 and/or 211 regulations, they have published industry guidance, Quality Systems Approach to Pharmaceutical CGMP Regulations. By Christine Park, Quality Architech
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Quintiles Deepens Investment In China
6/18/2012
In a ceremony underscoring the growing importance of China to the global biopharmaceutical industry, Quintiles executives and local dignitaries recently announced agreements to establish a Quintiles regional headquarters for China in Shanghai and to significantly expand lab testing capabilities in China.
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Clean Room Environmental Best Practices For Medical Device And Pharmaceutical Manufacturers Are Focus Of Boston Seminar On June 6
5/30/2012
Sterile manufacturing environments at medical device and pharmaceutical companies require effective cleaning and disinfection programs to maintain aseptic conditions and prevent microbial contamination. To help, laboratory testing experts will present "Clean Room Environmental Best Practices," a special seminar in Boston on Wednesday, June 6, 2012.