Authors
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Designing Transfer Carts for Class 100 ConditionsFDA has found several pharmaceutical companies not maintaining Class 100 conditions within transfer carts. The author discusses an approach for designing a transfer cart that will satisfy such conditions.
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A Detail View of Single-Use Equipment OpportunitiesThe authors propose increased use of single-use technologies in biopharmaceutical manufacturing to achieve operational excellence without compromising product quality.
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Filling of Asthma Inhalers with Liquid Nitrogen: Cryogenic Product Cooling of Aerosol PropellantsThis case study describes how a major pharmaceutical manufacturer was equipped with four filling lines, for metered dose inhalers, supplied with a nitrogen cooling system to prevent spontaneous vaporization of the propellant gas. By doing so, a cost-effective and environmentally friendly solution was provided to a hazardous situation, which also complied with regulatory directives.
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Commercialising cellular therapies fasterThere is much scientific evidence of the early successes of whole cell therapies as disease cures in chronic conditions and disease-modifiers in acute conditions, but limited cases of successfully transferring these discoveries to commercial products or therapies.
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Moisture-Activated Dry GranulationMoisture Activated Dry Granulation (MADG) was developed in response to the difficulties experienced with wet granulation, in terms of endpoint, drying and milling. Wet granulation process endpoint is very sensitive to granulation time and shear. The wet granules need to be dried to a narrow range of moisture contents, which is difficult. The dried granules need to be milled, but the milled granules often have either too many fines or too many coarse particles (or both) - an undesirable bimodal distribution.
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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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Controlling the Release of Highly Dosed and Highly Soluble DrugsThe authors formulated bupropion hydrochloride tablets with various grades of methacrylic copolymers and analyzed the properties of the resulting dosage forms. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."
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Hyperthermophilic Microorganisms and USP Hot Water SystemsThe author discusses why two of the industry's common practices for preventing microorganism contamination in USP hot-ware and purified-water systems may have no scientific basis.
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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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Verification Methods for 198 Common Raw Materials Using a Handheld Raman SpectrometerUsing handheld Raman spectroscopy, methods were developed and evaluated for 198 substances widely used as raw materials.
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Using Certified Reference Material to Produce Compliant Water Purity DataThere are apparent inconsistencies between the use of these reference materials and the manufacture of the reference solutions that are actually used in the regulated test method.
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Industrialized Production of Human iPSC-Derived Cardiomyocytes for Use in Drug Discovery and Toxicity TestingThe authors describe an industrialized process for the manufacture of iPSC-derived human cardiomyocytes. This article is part of a special issue on Bioprocessing and Sterile Manufacturing.
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The economics of excipient selection* Differentiate the suitability, quality and processability of an excipient. * Recognize the significant impact of superior excipient processability. * Understand the economic return associated with excipient selection.
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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.
