Articles in this Issue
This review is directed toward out-of-specification investigations with an emphasis on conducting laboratory investigations when employing Advanced Microbiological Methods that reflect the industry ...
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Gene therapy has emerged as a promising therapeutic for the treatment of genetic and acquired diseases. Gene transfection into target cells using naked DNA is a simple and safe approach that has been ...
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Expiration dating and storage conditions are required on the label for all pharmaceutical products. To establish a drug product’s storage condition and expiration date, a manufacturer must conduct ...
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Compressed gases are used at various steps of the pharmaceutical manufacturing process. Applications include weighing stations process line; use of gas to maintain an inert atmosphere above a liquid ...
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An entrepreneur can have a lasting influence on a company, and this has been the case with Jack Bush, who founded Millipore in 1954 to make use of his expertise in membrane filtration. Over the ...
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The U.S. biopharma and medical device markets remain the largest and most robust in the world. The statistics on the size and potential growth of these markets are staggering: the pharmaceutical ...
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The journey from discovery to clinical success is challenging in the complex landscape of biopharmaceutical development. One pivotal aspect that can significantly mitigate risks and enhance the ...
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In a previously published article entitled “The pain of change”, I postulated that because of the level of regulation of drugs and drug products or devices in place to ensure patient safety, the Life ...
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Manual titration is a well-established, and widely applicable technique for quantitation of analytes that has been in use for hundreds of years. While this technique can be used for analysis of a ...
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Biologically derived ingredients offer a whole host of possibilities for drug development. Sourced from living organisms, like plants, animals or microorganisms, they possess inherent therapeutic ...
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Maintaining and improving cleanroom manufacturing operations is required to ensure quality production of products. In today’s world, there are many challenges facing cleanrooms and controlled ...
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Microbiological testing plays a crucial role in ensuring the safety and quality of pharmaceutical products. Traditional methods, such as culture-based techniques, have been widely used for decades. ...
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With over 50 years of experience designing, manufacturing, and servicing innovative, high-quality, and highly automated processing equipment, AST, Inc. has revolutionized the aseptic fill/finish ...
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Antibody-drug conjugates (ADCs) are targeted medicines that deliver potent chemotherapy agents directly to cancer cells while reducing the risk of cytotoxicity and adverse effects. In the past years, ...
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An innovative new treatment is gaining momentum in cancer therapies and giving hope to patients worldwide. Antibody-drug conjugates (ADCs) are sophisticated therapeutics that combine the targeted ...
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Clinical research continues to have unmet needs specific to the enrollment of diverse patient populations that match real-world populations. Current research is unclear about whether offering clinical...
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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 2024.
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Mike Auerbach
The three publications that I work on – American Pharmaceutical Review, Pharmaceutical Outsourcing and Tablets&Capsules all consume a lot of news. We post daily news to all three websites and feature ...
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