Authors
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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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Developing Sterile Packaging For Aseptic EnvironmentsThe growing uptake of single-use sterile packaging in pharmaceutical production processes mirrors the broader trend towards single-use across every sector of the pharmaceutical industry.
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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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Analytical Data Management and Archiving: 21 CFR Part 11 Compliance and BeyondPharma laboratories are having to manage and archive more analytical data than ever before. With effective implementation of IT systems, companies can successfully prepare their electronic files for future retieval and use.
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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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Needle-free diluent technologyThe Needle-Free diluent kit is a concept created by bioluz and Technoflex in response to the FDA and the UK?s National Health Service (NHS) publishing recommendations to prevent healthcare staff from needle-stick injuries during the reconstitution of intravenous (IV) drugs.
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Applying Universal Anticounterfeiting TechnologiesIt is very difficult to measure the problem of counterfeiting accurately from year to year; by definition criminals don?t file tax returns or publish quarterly earnings.
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The Evolution of Single-Use Technologies in Aseptic ProcessingThe authors describe the origins of single-use components and explain their application to aseptic processes. They also show how disposable devices have changed over time and offer a glimpse of the future.
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Regulatory Update: The IPEC Novel Excipient Safety Evaluation ProcedureThe authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients.
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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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How A CMO Can Compete In An Increasingly Competitive MarketIn an increasingly competitive landscape, outsourcing providers are under mounting pressure to get their name out there and secure new and repeat business.
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Impurity Profiling Using Convergence Chromatography and Mass SpectrometryThe authors describe the use of convergence chromatography combined with mass spectrometry for impurity profiling.
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The PQRI Aseptic Processing Working Group: What was it? What Did It Cover? What Conclusions Did It Reach? Why Was It Important?Members of FDA, industry, and academia formed a working group within PQRI to openly discuss topics from a scientific perspective and provide formalized clarifications and recommendations to FDA to be considered and incorporated into FDA's draft guidance on aseptic processing.
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A Proposed Content-Uniformity Test for Large Sample SizesThe authors describe a modified version of the Large-N test used to determine content uniformity.
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When and why should the pharmaceutical industry use NIR chemical imaging?The author assesses the power and limitations of NIR chemical imaging and its future.
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Making a CRO project run smoothlyWhen embarking on a new outsourcing project, there are a few initial steps that must be taken to ensure a project runs smoothly from the start.
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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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High-Resolution Ultrasonic Spectroscopy: Analysis of MicroemulsionsThis article introduces the application of high-resolution ultrasonic spectroscopy (HR-US) for the analysis of emulsions and suspensions. The authors outline the principles of the technique and illustrate its application for analysis of the crystallization of lysozyme and the formation of a microemulsion.
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Data Integrity in the Analytical LaboratoryData integrity in the analytical laboratory is an area of increasing focus for regulators such as FDA.
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A New Approach to Forced Degradation Studies Using Anhydrous ConditionsIn this article, the authors demonstrate that a normal-phase chromatographic method was stability-indicating for a water-sensitive prodrug. The stress conditions using aqueous and non-aqueous conditions were also compared to understand the information obtained with each approach.
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Reducing the risk of microbial contaminationMaintaining asepsis and sterility is the primary challenge to implementing aseptic techniques and sterile processes in biopharmaceutical manufacture. Efforts to reduce the risk of microbial contamination of aseptically filled biotech products beyond their already low level represent engineering challenges, that don?t really compliment the progress in biotech R&D.
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Understanding The Requirements For Effective Nasal Drug DeliveryOne particularly crucial parameter for nasal sprays is the size of the droplets produced during actuation, which can potentially impact bioavailability.
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The Role of Normal Data Distribution in Pharmaceutical Development and ManufacturingReview challenges in the use of normality testing situations and recommendations on how to assess data distributions in the pharmaceutical development manufacturing environment
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Regulatory Update: The IPEC Novel Excipient Safety Evaluation ProcedureThe authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients.
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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.
