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In recent years, AI has become important in a number of fields in helping to make better use of information, increasing efficiency and enhancing productivity.

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There is a tremendous need to enhance delivery of potential therapeutics to the brain for treatment of central nervous system (CNS) disorders. The blood brain barrier (BBB) restricts and controls the exchange of compounds between the CNS and the blood, which requires discovery of new modalities allowing for effective drug delivery to the CNS. Polymer nanotechnology has now become one of the most attractive areas of pharmaceutical research. This review focuses on the current progress in polymeric nanoparticles, where the specific arrangement of the polymeric matter at the nanoscale is utilized to design drug delivery systems that provide safe and efficient transport of CNS drugs across the BBB.

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The scale-up of manufacturing processes to clinical production can be complicated and expensive, with many issues to consider. This article describes some of the common and less obvious pitfalls encountered by biopharmaceutical companies when scaling up protein production processes, and how to avoid them.

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Vendors who insist on using older and outdated technologies will eventually suffer increased pressure to follow the lead of those who adopt new technologies.

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Closed and disposable sterility testing devices reduce the risk of false positive results during sterility testing. To further prevent such results, some pharmaceutical manufacturers use the device inside a sterility testing isolator, which is decontaminated using sterilant gases or vapours. In this study, closed, disposable sterility test devices were exposed to two 90 minute vaporous phase hydrogen peroxide (VPHP) decontamination cycles within a sterility testing isolator and tested for device integrity, bacteriostasis/fungistasis and non-volatile residue content. The results showed that the VPHP used to decontaminate the isolator before sterility testing did not affect the device.

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This article presents a study of an aseptic environmental monitoring system for surface contamination at critical areas using a robot.

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This downloadable Failure Mode Effect Analysis tool accompanies the article titled 'The Application of Quality by Design to Analytical Methods' by Phil Borman et. al.

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This article presents a study of an aseptic environmental monitoring system for surface contamination at critical areas using a robot.

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In recent years, AI has become important in a number of fields in helping to make better use of information, increasing efficiency and enhancing productivity.

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Automation took hold gradually in the life-science industry. Its adoption brought the industry innovations and improved efficiency. Recent years witnessed the emergence of batch-automation systems and the development of standards for automation. The authors discuss the major changes automation brought to the industry and examine the rapid pace of technological development.

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In the concluding part of this article, the authors address diffusive-airflow imprecisions and measurements as well as automated integrity-test equipment, variations in bubble-point measurements, and the identification of a "sterilizing" filter.

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The presence of very low levels of residues (including solvents) in excipients is becoming an important issue for users, and the presence of very low levels of ?non-lactose? species in DPI lactose may pose challenges to suppliers and users.

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To date, calorimetry has not been given a fair trial in the PAT arena. Recent advances in reactor technology and design will ensure that real-time calorimetry is the present and future of PAT.

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The identification of an increasing number of drug targets coupled with advances in manufacturing technology could lead to many more blockbuster therapeutic antibodies.

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The authors evaluate the scalability of foam-granulation technology using continuous foam addition in high-shear granulation equipment at the laboratory, pilot and manufacturing scales. Immediate- and controlled-release model formulations were used. Continuous and batch addition of foam were compared for the controlled-release model formulation at the manufacturing scale, and physical testing was performed on the granules and finished tablets.

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Meeting the challenges of large-scale LC/MS/MS such as elminating carr-over and matrix effects can increase sensitivity and improve turnaround times.

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This article presents a study of an aseptic environmental monitoring system for surface contamination at critical areas using a robot.

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The author discusses the use of analytical sieving to determine the size distribution of granular and course powders and describes proper sieve construction and USP General Test {786&#125.

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Automation took hold gradually in the life-science industry. Its adoption brought the industry innovations and improved efficiency. Recent years witnessed the emergence of batch-automation systems and the development of standards for automation. The authors discuss the major changes automation brought to the industry and examine the rapid pace of technological development.

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Companies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.

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In this article, five industry experts share their insights to ensure that your column qualification protocols can survive the increased scrutiny of FDA inspectors.

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...Scotland has a favourable regulatory environment, funding support from its government and some of the most advanced research facilities in the world.

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In the biological arena, new and highly useful fluorescent markers are used to stain or 'label' specific structures of interest. They have transformed the range and applicability for optical observation. These labels are excited and correspondingly emit at specific wavelengths; thus, different facets of a specimen can be 'selected' by controlling the wavelength of the delivered and captured light. For example, labels such as 4',6-diamidino-2-phenylindole (DAPI) are used to highlight the nucleus of a cell and MitoTracker Orange is used for mitochondria. Figure 1 shows an example of a multiple stained section, viewed in fluorescence. There has been an explosion in fluorescent labels for examining biological structures, in fixed and live cell preparations.

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This article describes how rapidly disintegrating tablets containing a large quantity of an intensely bitter drug were successfully developed with a suitable level of masking, tablet hardness, disintegration property, dissolution profile and mouth feel.

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Recent technology improvements have made acrylics the preferred system for the aqueous enteric coating of tablets

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HR-US is a nondestructive technique with enormous potential for the analysis of materials and formulations used in the pharmaceutical industry.

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The closing date for comments to be received by the US Pharmacopeia (USP) for proposed revisions to Chapter <231>, which deals with analysis of heavy metals, is 15 December 2008. The USP has been working towards for approximately 4 years and the task has not been easy.

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This article focuses on upgrading and improving a packing process to comply with current good manufacturing practices. The authors sought to maintain proper quality assurance for finished products.