Articles in this Issue
Chewable gels (Gummies) are a long-standing confectionary product that due to their composition, processing, and physicochemical attributes e.g., low water activity (0.51 to 0.76) and pH (4.5), <4.5),>
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Imagine the human body as a complex machine, with countless processes and reactions happening every moment. Biomarkers are the measurable signs that reveal the state of this machine - whether it’s operating perfectly, under stress...
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Advances in the field of Advanced Therapy Medicinal Products (ATMPs) have given rise to this area of patient disease control and cure response, Figure 1. These advances have the shape of cellular and molecular biotechnology ...
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Attenuated total reflectance (ATR) infrared (IR) spectroscopy is an established tool in most analytical labs as it allows a rapid and comprehensive analysis with virtually no sample preparation. Studying samples with a high ...
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Do you know what percentage of citations in post-inspection, FDA Warning Letters relate to documentation issues and written procedures? The answer is a staggering 40%. Most manufacturing facilities still base their QC data ...
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Sterility testing is a critical quality control measure, that, when coupled with environmental data, proper aseptic technique, and robust process validation, supports that pharmaceutical products and compounded medications are ...
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Robert Dream
Recent scientific advances from genomic sequencing to the development of cell and gene therapies, nanotechnologies, end-to-end manufacturing, continuous manufacturing, and regulatory acceptance of these technologies as well as the...
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Ethylene Glycol and Diethylene Glycol contamination in liquid formulations pose significant safety risks. In recent years, multiple fatalities have been reported due to the presence of these contaminants in drug products. This ...
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In its overview of rapid technologies, USP outlines user requirements and discusses issues to consider when planning to validate a rapid method. It explicitly contains information on the ATP bioluminescence detection technology ...
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There are a number of implications to pharmaceutical microbiology due to the Annex 1 revision. Because the Annex 1 revision outlines Contamination Control Strategy (CCS) requirements, many manufacturers may find their programs to ...
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Understanding and enhancing patient acceptability towards medication regimens, particularly within the pharmaceutical sector, is paramount for achieving optimal therapeutical outcomes. Patient acceptability encompasses the ...
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In a fast-paced, rapidly evolving environment like Advanced Therapy Medicinal Product (ATMP) manufacturing, it is easy to overlook critical elements necessary to maintain contamination control. These critical and time-sensitive ...
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Gene therapies stand at the forefront of medical breakthroughs, promising revolutionary treatment possibilities. These therapies involve manipulating or modifying genes to treat or prevent diseases, presenting a paradigm shift in ...
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The use of disinfectants in a cleanroom requires a robust supplier quality approval program for each product, knowledge of the efficacy of the chosen disinfectant, and appropriate operator training in the application method. Each ...
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In a Good Manufacturing Practice (GMP) environment, the goal of cleaning is to remove the product and cleaning agent residues (if a cleaning agent other than water is used) to an acceptable level. Various methods of cleaning ...
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In any industry under strict regulatory control, GxP (‘good practice’) systems need to be formally validated as being robust and reliable in their ability to fulfill their intended purpose. This necessitates a process of computer ...
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The demand for robust patient data and real-world evidence (RWE) continues to grow as regulators, payers, researchers, and physicians look to answer questions throughout the entire lifecycle of a drug. While patient registries are...
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Today, everyone has something to say about the potential for artificial intelligence – including Generative AI - in transforming Life Sciences companies’ use of regulatory data. But where could technology really play a role 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 April and May 2024.
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Wearable technologies for pharmaceutical applications have been receiving a lot of attention recently. The COVID-19 pandemic showed the value of wearable technologies – especially for clinical trial use. When travel was restricted...
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