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Designing a winning process development strategyProcess development is an important aspect of biopharmaceutical development.1,2 Through studies in the pharmaceutical industry, Pisano suggests that companies able to develop and implement new process technologies quickly and effectively have a competitive edge. In addition, the fact that the production cost of biopharmaceuticals could be up to 25% of sales value means that the failure to develop a viable process could result in uneconomic manufacturing routes and the inability to capture fully the value of the firm's discovery.3
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Barriers and Solutions to Effective External Collaboration in BiopharmaAs biopharma companies rapidly change their focus, they may lack the laboratory space, instrumentation, and the scientific knowledge to support biologics research.
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Process Analytical Technology: Real-Time ReliabilityTo implement process analytical technology systems into the current information technology landscape, manufacturers will need to adopt continuously available systems and infrastructures.
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How polymeric microspheres deliver the goodsDrug delivery systems using biocompatible polymers allow controlled release of therapeutics, addressing many of the challenges of conventional administration. Polymer microspheres are attractive delivery systems, having a wide application in numerous therapeutic indications. This article reviews the current use and trends for polymer microspheres, and compares production methods and polymer characteristics.
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Distinguishing Between Cleanroom Classification and MonitoringA one-size-fits-all approach to monitoring practices and results is never appropriate, given the diversity of practice within the pharmaceutical industry.
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Characterization of Polymeric ExcipientsThis article summarizes the evolution of the viscosity standards and their corresponding applications in the USP−NF compendia.
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Integrity Testing of Sterilizing Grade Filters: Comparative Investigation of Pressure Drop and Flow Rate MeasurementsTesting sterilizing grade filters using integrity testers has become a standard method in biopharmaceutical production and quality assurance. In accordance with international regulations and recommendations, these filters should be tested before and after filtration. For these applications, a variety of automatic integrity testers is available. Currently, there are two groups of devices that are used to conduct validated testing procedures, such as the bubble point test, the diffusion test, and the water intrusion test (WIT) and water flow test (WFT). Whereas one group of devices relies on the principle of flow measurement, the other group is based on pressure drop measurements. The following report compares the accuracy of the two test methods, using the WFT as a reference.
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The Effect of Core Design and Formulation on the Quality of Film Coated TabletsThis article examines the importance of core design and formulation on the quality of a film coated tablet...
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Paperless Reporting: How to Satisfy FDAMost, if not all, pharmaceutical companies today are moving towards a paperless reporting structure. This article examines FDA's 21 CFR Part 11 regulations, which relate to technical and procedural compliance for electronic records and signatures.
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Calibration of Lyophilization Pressure GaugesMeasurements of lyophilization pressure are accurate only if the gauges that are used have been properly calibrated.
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Current Trends in BiomanufacturingThe limited effectiveness of some existing drugs and demand for new therapeutic candidated for complex diseases has spurred the development of the biopharmaceutical market...
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Controlled-Release of Oral Dosage FormsThe development of controlled-release formulations continues to be a big success for the pharmaceutical industry. The success of any technology relies on the ease of its manufacturing process and its reproducibility of desirable biopharmaceutical properties.
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Hydrogels for the Controlled Release of Pharmaceutical ProteinsTwo types of hydrogels used in parenteral protein-delivery systems offer opportunities for achieving a variety of prolonged- and delayed-release patterns.
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Targeted Cationic Liposomes: Technologies and DevelopmentsCationic liposomes are widely used in gene therapy as a safe alternative to highly immunogenic viral vectors. Attachment of a tissue-specific ligand to the surface of the liposomes can increase specificity and reduce undesired transfection. Targeted liposomes can be categorized as either immunoliposomes or ligand-targeted liposomes. The author provides a brief review of tumour-specific and liver-targeted cationic liposomes and strategies for the development of liposome?ligand complexes.
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The Future State of Computer Validation, Part II: Increasing the Efficiency of Computer Validation PracticesPart I of this article was published in the March 2003 issue of 21 CFR Part 11: Compliance and Beyond. In this issue, Part II discusses the potential advances and changes that must be made for computer validation to remain innovative and relevant to the industry.
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The Fabrication And Evaluation of the Formulation Variables of a Controlled-Porosity Osmotic Drug Delivery System with Diltiazem HydrochlorideThe study presented in this article used a controlled-porosity osmotic pump, which was prepared in the form of a bilayered tablet containing a drug compartment and an osmogen layer for the delayed release of diltiazem HCI.
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Nanotechnology Applications for Drug DeliveryNanotechnology is believed to hold enormous promise for the future of medicine and healthcare...
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Particle Engineering for Improved Dispersion in Dry Powder InhalersRespirable drug delivery is becoming increasingly popular because it provides a non-invasive route with rapid drug uptake, not only for the treatment of respiratory complaints, but also for the systemic delivery of substances that cannot be delivered orally.
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Using a Delphi Survey to Assess the Value of Pharmaceutical Process Validation Part II: Expert OpinionsEuropean expert opinions regarding pharmaceutical process validation were collected and studied by performing an Internet Delphi survey. In total, 36 experts from 10 countries representing the pharmaceutical fields of industry, regulation and academia participated in the survey. The overall attitude to process validation appeared to be positive; however, a number of concerns were raised. More education, better use of prioritizing tools and increased evidence of cost-effectiveness is needed to further develop and facilitate process validation.
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The Future State of Computer Validation, Part II: Increasing the Efficiency of Computer Validation PracticesPart I of this article was published in the March 2003 issue of 21 CFR Part 11: Compliance and Beyond. In this issue, Part II discusses the potential advances and changes that must be made for computer validation to remain innovative and relevant to the industry.
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Segregation of Powders during Gravity Flow Through Vertical PipesThe authors establish a quantitative framework for understanding the correlation between the segregation of pharmaceutical powders and various physical and process parameters.
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Lyophilization is not a freeze-dried technologyIn view of the nature of its complexity, it might be desirable to apply FDA's process analytical technology to lyophilization.
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E-Procurement — Successfully Using and Managing Reverse AuctionsReverse auctions can benefit both buyers and suppliers of goods and services, but extensive preparation and careful management are required to obtain those benefits.
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Understanding past & proposed changes to USP Chapter on Total Organic CarbonThe implementation of a total organic carbon (TOC) method into the United States Pharmacopeia (USP) has its origins in the early 1990s, when the Water Quality Committee (WQC) of the Pharmaceutical Manufacturers Association (PMA, later renamed PhRMA) debated improvements in the testing of purified water (PW) and water-for-injection (WFI). The resulting inclusion of modern analytical techniques replaced much older methods - some of which had been listed in the USP for more than 150 years. Finally, two new regulations were put in place: Chapter for conductivity, which replaced a series of individual ion tests; and Chapter which replaced the oxidizable substances test with a TOC method.
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Optimizing Loss-in-Weight Feeding of Poorly Flowing MaterialsPrior to use in a continuous manufacturing system for oral solid dosage forms, loss-in-weight feeders need to be tested and validated to understand the performance capabilities of a given material–feeder combination. In this article, the proper strategy for set-up and optimization of a loss-in-weight feeder is demonstrated for a range of materials. The optimized set-up of the feeders was demonstrated to provide suitable performance for even the most challenging, poorly flowing materials.
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Nanostructured Lipid Carriers: A Novel Generation of Solid Lipid Drug CarriersNanostructured lipid carriers are a new type of delivery system offering improved performance in terms of drug loading and long-term stability with the ability to form highly concentrated dispersions...
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The Preparation of Spherical Granules by Extrusion/Spheronization without Microcrystalline CelluloseThe process of extrusion/spheronization used to produce spherical granules frequently relies on formulations containing microcrystalline cellulose (MCC). This excipient can hold water, even when pressure is applied, and form "pastes" that have suitable rheological properties, which allow both extrusion and subsequent spheronization to produce uniform spherical granules. This article describes a new approach to providing paste systems with appropriate characteristics. This can be achieved by incorporating glyceryl monostearate (GMS) into the formulation. It was found that the inclusion of GMS in formulations provides a useful alternative to MCC as an effective excipient to aid the preparation of spherical granules, allowing the incorporation of drug loads as high as 90%.
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FDA's PAT initiativeFDA's recently released initiative has made process analytical technology (PAT) a hot topic in the life science industry. PAT describes the application of process analytical chemistry tools, feedback process control, information management tools, and product and process optimization strategies for the development and manufacture of pharmaceuticals. In this article, the author explores the impact PAT will have on the pharmaceutical industry.
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A practical approach to PAT implementationThe PAT guidance indicates a variety of risk-based approaches to managing the introduction of on-line analysers into existing processes with the aim of minimizing the regulatory burden for the manufacturer and encouraging innovation.
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Behavior of Uptake of Moisture by Drugs and ExcipientsThe influence of light on the rate of moisture gain was investigated in 36 drug substances and 18 excipients.
