Articles in this Issue
Over the last decade, there has been a significant focus on increasing process understanding and the implementation of Quality by Design (QbD) to ensure that pharmaceuticals matching a target product ...
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Transdermal drug delivery is a pain-free, non-invasive alternative to other parenteral options such as injection and infusion that similarly avoids first-pass metabolism in the gastrointestinal tract....
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In recent years, the adoption of continuous drug substance manufacturing has been steadily increasing. Companies such as Eli Lilly, GSK, Lonza, Novartis-MIT, Pfizer, Sanofi-Genzyme, and Sigma-Aldrich ...
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Thorough characterization of protein therapeutics is essential to ensure that drugs developed and manufactured meet all safety, efficacy, and quality requirements. Here we provide an overview of ...
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Production processes for biological products are often designed to include in-process hold steps to provide flexibility during operations. During hold conditions, process pools (a.k.a. process ...
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Today, one of the primary challenges in the production of consistent quality of recombinant adeno-associated virus (rAAV) remains the fact that current analytical tools are insufficient to meet all ...
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Over the past twelve years, immunotherapy has become an important treatment option for patients in the fight against cancer. One specialized approach within the field of cancer immunotherapy harnesses...
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Over the past decade and a half, the pharmaceutical industry has implemented Process Analytical Technologies (PAT) to design, analyze, and control manufacturing through timely measurements—with the ...
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What influences the way life sciences companies manage Quality today – and what does the future hold for the discipline as smart automation presents new ways for monitoring and pre-emptively ...
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Water quality monitoring is a cornerstone of pharmaceutical production. Whether used as a raw material or for processing, formulation, reagents, intermediates, and/or cleaning, water is fundamental to...
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The integration of single-use (disposable) processing equipment has become well accepted in the last 10-15 years. The growth of biological therapies helped spearhead the adoption of disposable bag-...
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Recent data revealed that some of the first people to receive Chimeric Antigen Receptor (CAR) T-cell therapy in 2010 still carry the cells in their blood. Scientists call this news a term not often ...
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Unsupervised statistical monitoring could have uncovered fraud at a clinical trial site around a year earlier than traditional methods were able to do. That was the main finding of an article recently...
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There is growing interest in the application of Single Pass Tangential Flow Filtration (SPTFF) systems for process intensification in biomanufacturing. In general, SPTFF refers to any membrane device ...
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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 February-March 2022.
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The pharmaceutical industry has always been interested in speed. Everyone hears about “speed to market”. Unfortunately, fast for the pharmaceutical industry has typically meant a 10 year wait from ...
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