Articles in this Issue
The authors have become aware that regulators, especially during site inspections, are beginning to ask questions about whether pharmaceutical manufacturers have considered setting time limits from the date of manufacturing to the...
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Process monitoring and control support the maintenance of a state of control during production and allow real-time evaluation of system performance. Common approaches to process monitoring and control including establishment of ...
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In recent years, regulatory focus has notably shifted from sensitivity to accuracy, underscoring a pivotal change in how we approach toxicological assessments. While sensitivity remains a critical requirement, our advancing ...
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Nearly 25 years after the first FDA-approved antibody-drug conjugate (ADC), the field of antibody therapeutics continues to evolve. Advances in antibody development and engineering, as well as transformative progress in our ...
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At a time when the pharmaceutical industry is entering a new transformational phase, the promise that automation, robotics, and concomitant digitalization hold is getting more and more recognition. The transition has long reached ...
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Anne Weeks and Anke Hossfeld share insights on why and how automation and robotics will change microbiological QC in pharmaceutical manufacturing.
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As mid-sized pharmaceutical companies expand globally, they face growing challenges. For example, the lack of global harmonization of post-approval regulatory requirements means that different regions and health authorities ...
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Pharmaceutical companies can stay adaptable in the rapidly evolving digital landscape by embracing digitalization and leveraging data-driven approaches for real-time monitoring and control. Technologies like deep learning and ...
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Generative AI (GenAI) is not a theoretical game-changer in life sciences; the technology is already transforming everyday regulatory and safety processes. This is thanks to its ability to digest, assess, and summarize key insights...
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VHP Applications History VHP has decades of successful use as a bio-decontamination process in the pharmaceutical industry and as a sterilization process in the medical device industry. This article will discuss the similarities ...
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The market need is the main driver. Today, access to quality Biologics drugs is limited to a minority of the patients around the world. Increasing the supply of biosimilars worldwide should contribute to making based treatment ...
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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 August-September, 2024.
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In the first season of Survivor, way back in 2000, and way before it became the cultural icon that it is today, Richard Hatch, a corporate trainer, and consultant, won the title of “Survivor”. During that first season, he ...
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The landscape of pharmaceutical development is rapidly evolving, with advanced therapeutic medicinal products (ATMPs), which include gene therapies, cell therapies, and tissue-engineered products, at the forefront of this ...
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The recent COVID-19 pandemic highlighted the urgent need for effective vaccines to protect public health. Over seven million people are reported to have died worldwide since January 2020 as a result of the disease,1 and this ...
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