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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.
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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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The Influence of Pregelatinized Starch Disintegrants on Interacting Variables that Act on Disintegrant PropertiesThis study evaluates the quantitative effects of the nature and concentrations of disintegrants and a tablet's relative density on disintegrant properties such as disintegration time and the crushing strength-friability/disintegration time ratio.
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Time Is Of The EssenceGiving contamination time to build up can cause headaches for more than just your company.
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Project Management and CMO–Sponsor RelationsUsing basic project management tools and ideas in the transfer process saves time and money and ensures high success rates.
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From Quality by Inspection to Quality by Design: A Roadmap for SuccessCompanies must create a risk-based framework for developing and manufacturing drugs, and acquire the scientific knowledge and technological skills to create more complex products.
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Why It Pays To Be CleanProcess industries are faced with increasing demands for product safety, improved quality, efficiency and profitability. The chemical, pharma and cosmetic industries are no exception.
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Understanding Data, Symbol, and Technology OptionsAlthough the main purpose of the proposed unit-of-use bar coding mandate is to reduce medication errors, manufacturers may find additional benefits to compliance, including reduced materials and finshed-good inventory requirements, improved sample management, and streamlined recalls.
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The role of media fills in process controlThere is currently no vaccination or cure for prion diseases and contamination of a parenteral or infusion pharmaceutical product could prove fatal.
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Designing & Implementing Pharmaceutical Clean RoomsPossible cross-contamination issues should be eliminated at the early stage of the project. The project sponsor should ensure that all relevant personnel from the production, quality control, logistics, and maintenance departments, as well as engineering, are involved in the conceptual stages of a design.
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Clean Rooms and Air Handling Systems — Design for ComplianceThis article provides an overview of the important factors associated with air handling systems within pharmaceutical and biopharmaceutical facilities. It provides information on the need for these systems, design considerations and advice on the approach to commissioning and qualification.
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Analysing Raw Materials and Formulations Using High Resolution Ultrasonic SpectroscopyHR-US is a nondestructive technique with enormous potential for the analysis of materials and formulations used in the pharmaceutical industry.
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Containment Levels and Facility DesignThe influence of containment classification in facility design cannot be underestimated. It can, for example, determine the extent of the design process and the level of equipment needed to safeguard human life and the surrounding environment. This article discusses factors that should be considered when planning such a containment facility, including material flow, process equipment and regulatory guidelines.
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Pharmaceuticals visualize successWith a finger on the pulse of an evolving market, the sales and marketing team can visually demonstrate trends and new market opportunities to the R&D team
