Articles in this Issue
Scientists have long been perceived and portrayed in films as old people in white lab coats perched at a bench full of bubbling fluorescent liquids. The present-day reality is quite different. Scientists are increasingly data ...
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In January 2023, ICH Q9 Quality Risk Management was updated. Managing and minimizing subjectivity within quality risk management (QRM) was a major addition. Section 5.3 of the guidance notes that subjectivity can impact the ...
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Novel container closure system (CCS) technology may allow multiple-dose drug products to be marketed without added antimicrobial preservatives to meet clinical and formulation needs. In order to ensure patient safety, however, ...
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Despite all the medical advances we have achieved over the last hundred years, there are still too many diseases we can’t treat or treat with a long list of undesirable side effects. To state the obvious, humanity needs to find ...
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End-to-End (from seed to unit dose - E-2-E) manufacturing represents the next generation of biopharmaceutical manufacturing processes for both large and small molecules. It is recognized by regulatory authorities as a key emerging...
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As the pharmaceutical industry enters a new transformational phase, there is immense potential for automation and digitalization to improve workflows and boost productivity. Innovative solutions are being implemented in all areas ...
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The global biopharmaceutical market is expected to grow at a Compound Annual Growth Rate (CAGR) of 12.5% reaching a value of $856.1B by 2030. Fueling this growth is the prevalence of chronic diseases, a growing geriatric ...
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By bringing trials directly to patients, decentralized clinical trials (DCTs) offer a host of compelling benefits, including reduced patient burden, such as travel and financial obligations, making it easier for patients to ...
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The FDA’s definition of “real-world data” (RWD) includes “data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health ...
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A goal within the FDA Division of Microbiology Assessment is to improve the quality of the sterility assurance submission for Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA). To meet this goal, we ask ...
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In recent years, there have been major improvements and advancements in pharmaceutical technology with regards to quality control testing. One test which falls under this category is the Limulus Amebocyte Lysate (LAL) test which ...
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Exyte offers the full suite of engineering, design, procurement, construction, construction management, qualification and validation services to highly complex projects on behalf of the world’s leading biopharma and life sciences ...
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Method Validation/Verification? The ever so daunting words in any Good Manufacturing Practice (GMP) Quality Control (QC) Microbiology Laboratory. If you are a new lab manager and/or analyst just starting in the pharmaceutical ...
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Drug development has evolved significantly over the past couple of decades, particularly within the large molecule biotherapeutics arena. In a growing market, the therapeutic specificity of biotherapeutics has resulted in a number...
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Lipid nanoparticles are a holistically superior formulation for dermal drug products, which combine effective drug delivery and skin carrying properties at the same time.
Skin is a popular route for the delivery of locally and ...
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Can you tell us about ACG Group? What services and technologies does the company offer to help pharmaceutical companies research and develop new drugs?
ACG is committed to making the world healthier and finding innovative ...
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Each year, exhibitors at INTERPHEX are invited to submit their new innovation or technology for a chance to be recognized. To win, the company or technology must excel in each criterion, demonstrate leading market knowledge and ...
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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 and April 2023.
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The term “Rogues’ Gallery” has been around for quite some time.
Used by law enforcement agencies for identification purposes, it is generally defined as a collection of mug shots along with descriptions, methods of operation, ...
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