Authors
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Third-Party Technology TransferCareful planning and decision-making can circumvent possible delays in technology transfers.
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Green containment philosophyForward-thinking manufacturers are recognizing the need for a more sustainable approach to containment design.
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Hot-melt extrusion: an emerging drug delivery technologyHot-melt extrusion offers many advantages compared with conventional solid dosage form manufacturing, and has consequently received considerable attention from both the pharmaceutical industry and academia as a novel drug delivery technology. The possibility of forming solid dispersions with improved bioavailability renders hot-melt extrusion an excellent alternative to other conventionally employed techniques.
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A guide to EFPIA's Mock P.2 documentEFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.
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Contractually speakingLiability issues are often controversial, but much depends on the nature of the agreement.
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The Challenge in Bioprocess Development: From Data to KnowledgeThe senior director of Oracle's Life Sciences Business Unit tackles some of the technical issues regarding regulatory standardization, software integration, and the trend toward visualization, among other things.
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Solubility, Polymorphism, Crystallinity, Crystal Habit, and Drying Scheme of (R, S)-(±)-Sodium Ibuprofen DihydrateThe racemic compound (R, S)-(±)-ibuprofen is a popular and well understood active pharmaceutical ingredient, but it has several disadvantageous formulation properties such as poor solubility, low melting point, and potential esterification with excipients containing an hydroxyl group. The authors investigate the use of an (R, S)-(±)-ibuprofen salt to evaluate these problems using various analytical methods to determine the polymorphism, crystallinity, and drying scheme.
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Manufacture of Asymmetric Hydrogenation CatalystsSingle-enantiomer drugs represent an increasingly large share of new chemical entities, leading to approaches in asymmetric synthesis.
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Foam GranulationThe authors review developments in wet granulation using a twin-screw extruder.
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A guide to EFPIA's Mock P.2 documentEFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.
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Exploring Newly Introduced Methods for Testing MDIs with Add-On DevicesThe role of add-on devices and how they affect drug delivery with a pressurized metered dose inhaler.
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Converting Intravenous Dosing to Subcutaneous Dosing With Recombinant Human HyaluronidaseThe preferred route of administration for an injected therapeutic agent is subcutaneous (SC), but SC injections are generally limited to no more than 1-2 mL in volume, representing a major challenge, especially for large protein biologics.
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Testing Topicals: Analytical Strategies for the In-Vitro Demonstration of BioequivalenceThis article examines IVBE testing requirements for topical creams and explores some of the analytical techniques necessary.
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Bridging the Development–Manufacturing Gap to Achieve QbD and PATTo implement QbD and reduce business risks, teams should begin QbD collaboration early during process development.
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Available Guidance and Best Practices for Conducting Forced Degradation StudiesParticipants at a Pharmaceutical Research and Manufacturers of America workshop share their views about the acceptable analytical practices of conducting forced degradation studies.
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Using Electronic Batch Records to Their Full PotentialIntegrating EBRs with MES reduces time to market, cuts costs, and enhances compliance performance.
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20th Anniversary Special Feature: The transformation and future trends of laboratory data managementHistorically, the main purpose of laboratory information management systems (LIMS) has been to track and manage samples in the laboratory. LIMS originated nearly 30 years ago as a rudimentary method of automating manual, error-prone processes in the laboratory and, with the growth in adoption of technology, became the de facto benchmark for laboratory control and management.
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Monitoring processing-induced crystallinity changesThe crystalline structure of pharmaceutical solids can sometimes be altered during processing. X-ray powder diffraction and near infrared spectroscopy can be used to determine the amorphous and crystalline content of a model substance. The two techniques' precision, accuracy, detection limit and the speed of analysis are compared.
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Preventive maintenance strategies for the pharmaceutical industryMaintenance and service-related items are often the second-largest budget element in a laboratory after salaries and benefits. Within maintenance, preventive maintenance (PM) is a substantial portion of the budget. Traditionally, PM was an equipment maintenance philosophy based on replacing, overhauling or remanufacturing a piece of equipment at fixed intervals, regardless of its condition at the time. In essence, it involved fixing something that wasn't necessarily broken and this approach is still widely used in the pharmaceutical industry.
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Critical control pointsSuch an approach inevitably leads to increased front-end costs, but the advantages include better quality, reduced wastage and less product variability.
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Quality Systems for Drugs and BiologicsFDA is modernizing and streamlining current good manufacturing practices. The author examines FDA's evolving approach to quality systems and how a manufacturer can implement a quality system framework.
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Environmental packaging waste regulationsIt will remain to be seen whether pharmaceutical companies will commit lock, stock and barrel to being green.
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The Challenge in Bioprocess Development: From Data to KnowledgeThe senior director of Oracle's Life Sciences Business Unit tackles some of the technical issues regarding regulatory standardization, software integration, and the trend toward visualization, among other things.
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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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Perspectives on Quality Attributes of Drug Products Containing NanomaterialsIn this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.
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A guide to EFPIA's Mock P.2 documentEFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.
Latest:
A guide to EFPIA's Mock P.2 documentEFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.
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Terahertz applications for the analysis of solid dosage formsThis article investigates pharmaceutical applications of terahertz technology, specifically using techniques for solid dosage form analysis such as pulsed spectroscopy (to generate physical information and detect API changes) and pulsed imaging (to locate formulation impurities, and regulate tablet coating quality and thickness).
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Who's afraid of parallel trade?How much do you know about parallel trade? Perhaps you may have heard someone mention these words and have then switched off. In a sense, it's hardly surprising given the fact that most media coverage centres on interpretation of complex legal cases. By the time you reach the end of these types of articles, you can't work out what the mentioned companies were arguing about in the first place and on which technical details the case was judged. Yet, time after time, a legal ruling on a parallel trade issue rockets to the front pages of the pharmaceutical press and even, occasionally, the mainstream media.
