Authors
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A Novel Copovidone Binder for Dry Granulation and Direct-Compression TabletingThe author assesses the compressibility of Plasdone S- 630 copovidone-based tablet formulations using roller-compaction and direct-compression processes.
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Implementing A Successful Lean Program: Where Do You Begin?A case study describing how Lean can drive the creation of an improved culture within pharmaceutical companies.
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Implications and Opportunities of Applying QbD Principles to Analytical MeasurementThe authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.
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String of attacks aimed at Novartis CEONovartis has confirmed that the ashes of CEO Daniel Vasella's mother have been stolen and his holiday home set fire to.
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One-Step Aqueous Enteric Coating Systems: Scale-Up EvaluationPoly(vinyl acetate) phthalate-based and acrylic-based enteric coating systems are evaluated for their performance on acetylsalicylic acid tablets in areas such as acid resistance and coated-tablet stability.
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Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory TemplateA published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
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Implications and Opportunities of Applying QbD Principles to Analytical MeasurementThe authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.
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What pharma can learn from general manufacturing in a recessionWhile pharma is not synchronized with the boom and bust of the general economy, lessons from the business cycle facing manufacturers can enable the pharmaceutical industry to tackle the problems it faces.
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Inspiring the Next GenerationScientists can share time and pharmaceutical knowledge with high school students.
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Should you implement single-use systems?Using single-use systems for investigational medicinal product manufacturing has its advantages and disadvantages.
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Rise of the robotsAlthough once used only for large production processes, robotics are now working their way into every aspect of the pharma manufacturing processes.
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Glove Selection for Controlled EnvironmentsChanging or upgrading cleanroom gloves requires time and due consideration. A good decision could improve employee satisfaction and product yields, but a bad decision could necessitate millions of dollars worth of rework, recalls, and rejects if the gloves don?t perform as expected. Personnel should consider various criteria to choose the best glove for their cleanroom.
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Degradation And What It Means To The Supply ChainProduct degradation is often overlooked compared with other supply chain issues, but if left unchecked can lead to the market entry of substandard medicines, whether through ignorance or gross negligence.
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FDA Perspectives: Revising the 1987 Industry Guideline The Development of FDA's Guidance on Aseptic ProcessingThe authors describe the solicitation of industry input for the guidance through a process that included a 2002 meeting of the Advisory Committe on Pharmaceutical Science and the subsequent formation of the PQRI Aseptic Processing Working Group.
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i-Series Plus integrated HPLCSignificantly improved analytical productivity with automated pretreatment operationsThe i-Series Plus, designed for covering conventional to ultra-fast LC applications, consists of the compact HPLC Prominence-i and UHPLC system Nexera-i. High speed analysis, simplified method transfer, minimized environmental impact and easy maintenance are just a few of the many new features of this product range
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Achieving site-specific PEGylationPEGylation has been around for 30 years and it is surprising that it is still widely used given the significant advances that have been made in biopharmaceutical manufacture since then. So why is this the case?
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Is change good for you?With the pharmaceutical industry being in a current state of unrest in light of the recent spate of mergers, acquisitions, job cuts, divestments, patent expiries, and so on, we wanted to know how you felt about all these changes that will have directly or indirectly affected you.
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The Introduction of GMP for APIs in the European UnionEuropean Directive 2004/27/EC will have massive repercussions on the manufacture and marketing of APIs and some excipients across Europe...
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Engineering Processing Properties of Acetaminophen by Cosolvent ScreeningThe authors used common solvents to develop an initial solvent-screening method for laboratory-scale research to determine the solubility, polymorphism, and crystal properties of various active ingredients.
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Data Matrix Barcodes: You Can't Control What You Can't MeasureWyatt Earp, the legendary sheriff of Tombstone used to solve troubles in a simple way: aiming, pulling the trigger and bang! ... problem eliminated! Some manufacturers check the readability of their barcodes in the same way.
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Ultrasonic calorimetry of membranesCan high-resolution sound velocity measurements be used as an analytical tool?
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Achieving More Effective Cell Culture With Single-Use SystemsThe benefits that can be gained by integrating single-use systems into a commercial cell culture facility depend on whether the systems are to be used in an existing or a new facility. It is usually more beneficial to use Single-use systems in a new facility because this offers the opportunity to reduce the requirements for floor space and to reduce or eliminate the need for utilities, such as steam, ventilation, cleaninplace systems, water systems, etc.
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A Fresh Coat: Innovation in ExcipientsSophisticated excipient development, especially for coatings, is staying on top of new challenges and meeting expanding industry needs.
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Pharmaceutical Reserch and Manufacturers Association Acceptable Analytical Practice for Analytical Method TransferThis article presents the findings of PhRMA's annual workshop, held in September 2000, that convened to draft an acceptable analytical practice that would clarify the essential elements of a complete and compliant transfer.
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A Literature Review of Pharmaceutical Process ValidationThe renewal of European regulations regarding pharmaceutical process validation in autumn 2001 has been the subject of much discussion. The purpose of this article is to summarize and review the development of pharmaceutical process validation, and demonstrate how industry opinion regarding the concept has shifted from that of a regulatory burden to something driving total quality management and cost benefits.
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Reduced-Method Robustness Testing of Analytical Methods Driven by a Risk-Based ApproachThe authors describe a novel approach for assessing method robustness. This article contains online-bonus material and was copublished with Pharmaceutical Technology Europe.
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Quantitative open-access HPLC analysis: a new calibration approachA novel tool enables users to generate reliable data for yields in solution and for assays of isolated solids using high?performance liquid chromatography without having to prepare standards.
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Speeding Sample Preparation and API Extraction from Solid Oral Dosage FormulationsLaboratory testing found that a novel approach reduced the time required for sample preparation from hours to minutes. This article summarizes test methods and results.
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The challenges of outsourcing early developmentOutsourcing early drug development can be viewed from a tactical or strategic perspective. These perspectives are often driven by the size of the company and provide different advantages.
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Using Quality by Design to Develop Robust Chromatographic MethodsThe quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.
