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A Comprehensive Approach to Pharmaceutical Engineering TrainingA training program at Rutgers University combines the disciplines of engineering and pharmaceutics to provide a thorough educational experience in drug manufacturing.
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Improving speed and quality in vaccine productionWhile single-use technologies can be used for filtration, storage and at connection points in egg-based vaccine production, their use multiplies in cell-based applications.
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Characterization with Atomic Force Microscopy, Topographic, and 3D RamanThe authors describe how a combination of imaging techniques can be used to provide topographic and chemical information to characterize a sample.
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Excipient-Excipient Interactions in Pharmaceutical Systems Intended for Topical ApplicationBioadhesive films cast from aqueous blends of PMVE/MA have diverse uses, such as a means of establishing an electrically conducting interface for bioelectrodes and as an adhesive drug delivery matrix.
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Aseptic Formulation and Filling Using Isolator TechnologyIsolator technology can be used in clinical product formulation and filling facilities to ensure environmental control and reduce contamination risk in aseptic processing.
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Speeding up the move to PATThe big challenge for pharmaceutical companies is to mathematically model their production processes, combining both data from the laboratory and the production process.
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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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Evolving concepts in plant design: part 1The construction of a new oral solid form (OSF) plant is an important decision and a real challenge. The team in charge of the basic conceptual design has to ensure that the new plant will be up-to-date and efficient not only at start-up, but for the next 15–20 years. This means that the project must be able to adjust to capacity changes, product changes and technology changes. It sometimes seems like an impossible challenge.
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Financing the French futureThe creation in the Paris Region of a multidisciplinary Institute of Technology will bring together the best researchers in world, innovative SMEs and the research centres of large industrial groups.
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Installing Clean Process LinesWhen planning the installation of a new stainless steel process pipeline, it is important to understand the significance of using the best possible materials and techniques to ensure it is clean when installed. This article examines the factors that must be considered when planning and constructing a new process line.
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Implementing and Maintaining a Drug Safety SystemThe collection, investigation and monitoring of suspected adverse drug reactions (SADRs), and associated product use and complaint information, is a regulatory requirement for all manufacturers of pharmaceuticals for human use.1 This process, called pharmacovigilance or drug safety, appears to be fairly standardized between different pharmaceutical companies and usually contains the elements outlined in Figure 1.
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The Future of Metered-Dose InhalersIAdvances in pressurized metered-dose inhalers (pMDIs) in terms of formulation capability and the performance of the container closure system enable products to be developed faster and with less technical risk. Despite new delivery devices for new molecules breaking into the pMDI market, pMDIs have the ability to gain regulatory approval significantly faster than a novel device, which could save a company many hundreds of millions of pounds.
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20th Anniversary Special Feature: Outsourcing biologics manufacturingBiopharmaceuticals are the most rapidly growing segment of the pharmaceuticals market. Developing and marketing biopharmaceuticals are huge roles in almost every major pharmaceutical company's strategy. However, they are extremely complex molecules and are highly sensitive to the manufacturing processes used to produce them. These processes require exquisite control of living production systems, making, without a doubt, biopharmaceuticals one of the most challenging products of any type to manufacture.
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Biopharmaceuticals: Insight into today's market and a look to the futureThe worldwide market for biopharmaceuticals was estimated to be $50 billion in 2005. North America accounts for 60% in terms of revenue and R&D. Europe accounts for 20% and Japan 10%. It is also estimated that 400–500 biotech drugs are under clinical development for various disease conditions. Biopharmaceuticals are being developed to fight cancer, viral infections, diabetes, hepatitis and multiple sclerosis. The distinct families of biopharmaceuticals include
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The Effect of Vaporous Phase Hydrogen Peroxide on Sterility Test DevicesClosed 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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Contaminated LVPs and the Origins of ValidationFundamental validation skills related to heating, ventilation, and air conditioning must be thoroughly understood. Knowing the early history and development of validation is essential to understand the current set of regulations and standards governing the industry. This article reviews the history and outcome of contamination in large-volume parenteral drug products and discusses the qualification requirements of modern HVAC systems.
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Changes in US Policy: What Generic Pharmaceutical Companies Need to KnowIn this article the authors examine a number of significant amendments to US policy regarding generic pharmaceuticals. These important changes could have a major impact not only on the US pharmaceutical market, but also globally. The US Food and Drug Administration (FDA) implemented new regulations, effective from 19 August 2003, that promise to benefit generic pharmaceutical companies in several ways. Significantly, they seek to prevent multiple 30-month stays and resolve much of the uncertainty regarding which patents may properly be listed in FDA's Orange Book.1,2
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Automating HPLC and GC Analytical Method ValidationA newly developed software program transforms written SOPs for all required analytical method validation experiments into transferable automated templates, integrating individual activities and technologies under one platform.
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A new system for the rapid transfer of sterile liquid through a containment wallSterile liquids are frequently transferred during the processing of sterile liquid drugs such as injectables or ophthalmic drops. Several types of transfer can be performed, each requiring a validated method to ensure the desired sterility-assurance levels are achieved.
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PAT: “Gateway Drug” to the 21st Century for the Pharma IndustryProcess analytical technology paved the way for continuous manufacturing.
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New age therapiesWhy do the biotech ventures mange to have such promising drug candidates while pharmaceutical R&D is facing a drug deficit?
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The New Biopharmaceutical Blueprint: Service-Oriented Architecture in ManufacturingMore than ever, drug makers need to be fleet and flexible-and they need their software to be the same.
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Formulation Variables on Pellets Containing Self-Emulsifying SystemsThis high quality of pellet roundness is surprising in view of the high extrusion forces required to extrude the wet masses.
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Excipient-Excipient Interactions in Pharmaceutical Systems Intended for Topical ApplicationBioadhesive films cast from aqueous blends of PMVE/MA have diverse uses, such as a means of establishing an electrically conducting interface for bioelectrodes and as an adhesive drug delivery matrix.
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Understanding powder behaviour by measurig bulk, flow and shear propertiesThe trend towards developing pharmaceutical products and their manufacturing processes in tandem supports optimized production. Such developments rely on gathering process-relevant information at an early stage and being able to draw on past and current processing experience. Here, we discuss how powder rheometers can make a real difference in building a database of powder properties and removing subjectivity.
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Real-Time Measurement of Coating Film ThicknessOptical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.
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Formulation Variables on Pellets Containing Self-Emulsifying SystemsThis high quality of pellet roundness is surprising in view of the high extrusion forces required to extrude the wet masses.
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Evaluating Impact of Personalized Medicines on Pharmaceutical ManufacturingInterphex2007, New York, NY (Apr. 26)-As focus shifts away from "one-size-fits-all" medicines and begins centering on personalized medicines, many companies begin to wonder how they can manufacture such drugs economically. Mark Hirschel, chief scientific officer of BioVest International, addressed that issue in his presentation, "A Bioreactor System Designed for Production of Personalized Therapeutics," at Interphex on Thursday.
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Trends in mass spectrometryTo fully optimize MS performance, corresponding enhancements are required in the other functional components of the integrated LC/MS platform.
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The Real Complexity of Excipient CompositionThis article seeks to promote dialogue among stakeholders to facilitate consensus regarding requirements for excipients.
