Articles in this Issue
Computer vision (CV), a form of AI that uses an algorithm to identify, process and analyze vast amounts of text, images and videos that would be impossible to address with the human eye, has been ...
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The human immune system is a powerful, intricate defense system that is effective against a wide range of microorganisms and other invading contaminants. However, one’s own immune system can pose a ...
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Compliance with Good Manufacturing Practice (“GMP”) is mandatory for all medicinal products that have been granted a marketing authorization. Likewise, the manufacture of investigational medicinal ...
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It may seem counterintuitive, but the often-reported shortage of large batch CDMOs and the resulting backlogs in production actually may hit small batch manufacturing companies the hardest. The ...
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The texts of the European Pharmacopoeia (Ph. Eur.) play a major role in ensuring the quality of medicines in Europe. They consist in general chapters and monographs, which are mandatory quality ...
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Even without the pandemic in place, we were in a challenging time for most traditional pharmaceutical companies. The high competitiveness of the market, increasing international regulatory ...
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This paper presents Roche’s validation strategy of the recombinant factor C (rFC) endotoxin testing method. The validation approach uses statistical non-inferiority hypothesis testing based on spiked ...
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Core tools used for research and development in pharmaceutical laboratories, such as media capture, integration, and electronic notebooks, have not kept pace with the electronic multimedia tools and ...
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Vaccines have revolutionized the world’s ability to prevent, mitigate the impact of and, in some cases, eliminate the threat of certain infectious diseases and improve overall health. The clinical ...
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Data integrity is of the utmost importance when testing and analyzing products and devices in the Quality Control (QC) laboratory. In an increasingly automated world, demands are also rising in the ...
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All hand sanitizers, whether used by consumers or healthcare professionals, are considered over-the-counter (OTC) drugs that are regulated by the FDA. The most common type of hand sanitizer has ...
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This review article discusses the microbial contamination risk factors presented in USP General Informational Chapter <1111> Microbiological Examination of Non-sterile Products: Acceptance Criteria for 1111>...
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Eurofins BioPharma Product Testing highlights how it helps clients in the bio/pharmaceutical industry overcome challenges in sterile fill finish manufacturing with a state-of-the-art robotic vial ...
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Many biopharmaceuticals are recombinant proteins obtained by biotechnological processes. In various steps of the pharmaceutical value chain, from drug discovery, to development and manufacturing, to ...
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As a global provider, Merck offers a wide range of products and services to biopharma. On the analytical side, we have a growing selection of chromatography and sample preparation products for ...
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The use of injectable materials for soft-tissue augmentation has been increasing globally (1). The US FDA has approved materials such as calcium hydroxylapatite, poly-L-lactic acid (PLLA), ...
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Gene therapy is a modality that requires a complex analytical control strategy to ensure safety and efficacy of the drug product. Adeno-associated virus (AAV) is widely used as a vector for ...
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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 October-November 2021.
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A long, long time ago when I was in college, I pledged a fraternity. It was a new fraternity, and me and my six other pledge brothers were the first pledge class.
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