Articles in this Issue
In 1971 the Who released the album Who’s Next. The album was an immediate success and has been mentioned by many music critics as their best album and one of the greatest albums of all time. Songs from the album include such ...
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Cancer research is complex: trials require specific design expertise and often include biomarker and companion diagnostics, and failure rates tend to be higher than for drugs tested in other therapeutic areas. To mitigate risks ...
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The COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected more than 160 million people worldwide. Researchers have targeted the SARS-CoV-2 structural proteins to better combat the ...
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Over the last decades Process Analytical Technology (PAT) has been widely used in pharmaceutical development to support process understanding and optimization. Among the different technologies, Near Infrared Spectroscopy (NIRS) ...
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For nearly four decades, the U.S. Food and Drug Administration’s (FDA) expectation has been that pharmaceutical Quality Control (QC) microbiology laboratories include in their media growth promotion testing (GPT) not only type ...
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InVitria provides an alternative to serum and serum-proteins in the production and formulation of therapeutics. We specialize in creating completely blood-free raw materials for research and manufacturing for gene therapy, cell ...
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EU GMP Annex 1, which regulates the manufacturing, control and release of sterile pharmaceutical products, is undergoing some substantial changes, as the current 2020 draft suggests. These will directly affect manufacturers in ...
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One of the many challenges for startup biotech companies is generating Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring and Available (ALCOA+) supporting DATA in establishing drug ...
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Continuously surging numbers of global COVID-19 cases caused by rapidly emerging SARS-CoV-2 mutants forming more contagious and deadly viral strains force our scientific capacity to find creative ways to control the pandemic. ...
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Regardless of industry, maximizing the value of data has become an important objective in the digital age. As more pharmaceutical operations find themselves tasked with building long-term digital strategies, the most fundamental ...
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The purpose of a Stability Program is to support the expiration dating of pharmaceutical products, medical devices, and biologics and recommend storage conditions. These products are manufactured and placed in special ...
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Manufacturing sterile parenteral products with aseptic technique has become more complex because of multiple technical, scientific and compliance challenges. This article recommends an overall approach based on structure, ...
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Ascendia Pharmaceuticals is a specialty pharmaceutical CDMO that provides custom sterile- and non-sterile-enabling formulations, along with analytical methods for new chemical entities, complex dosage forms, and 505(B)(2) product ...
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Lipid-based excipients are present in a wide range of drug delivery systems for different routes of administration, including oral, topical, transdermal, and parenteral. By their nature, lipid-based excipients confer unique ...
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When thinking about caffeine, the first thought that often comes to mind is the drink “coffee”, despite the fact that caffeine can be obtained from a variety of other sources. Coffee dominates modern drink consumption, but tea was...
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The United States Pharmacopeia (USP) specifies regulations for pharmaceutical manufacturing and testing to ensure safe and effective drug products. USP Total Organic Carbon (TOC) pertains to requirements for testing pharmaceutical...
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The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in March 2021.
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