Authors
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Guest Viewpoint: A Case for an FDA Dean's ListQuality is a matter of culture more than metrics. In this opinion article, the author presents arguments for an FDA Dean's List as a means to nurture a quality culture within the industry.
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The Future of Downstream ProcessingThe author reviews the state of downstream processing and considers potential solutions, including the streamlining of full processes and borrowed technologies.
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Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified CommunicationsIn Part 1 of this blog, Richard Freeman looked at some of the challenges faced by pharma firms today as a result of growing competition, regulation and globalization, and argued that more effective communication and collaboration was key to their continued success.
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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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Bridging the Gap from Molecule to DrugFormulation expertise can smooth the transition of a prospective therapy from medicinal chemistry to drug dosage form.
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QbD: Improving Pharmaceutical Development and Manufacturing Workflows to Deliver Better Patient OutcomesImplementing quality by design in product design and formulation and manufacturing workflows can help improve efficiency and shorten development times.
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Checklist for Computer Software ValidationNon-compliance issues show that users find dealing with computer systems challenging.
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Achieving Lean Processing With Single-Use SystemsSingle-use filtration and fill–finish technologies can be used as part of a lean manufacturing strategy to boost production, and reduce manufacturing waste and costs.
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Determination of Related Substances in Pemetrexed Disodium (Form-IV) in Bulk Drug Samples by HPLCThe authors describe the development of a stability-indicating reverse-phase high-performance liquid chromatographic (RP?HPLC) method for the quantitative determination of potential genotoxic impurities present in pemetrexed disodium (form-IV). The chromatographic separation was achieved on a RP?HPLC column (Zorbax SB-Phenyl, Agilent) at ambient temperature with gradient elution using mobile phase A (trifluoroacetic acid [TFA] in water) and mobile phase B (TFA in acetonitrile).
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Can Bigger be Better?The industry is becoming more consolidated, but there needs to be some strategy behind the mergers and acquisitions.
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Specifying a tumble blender for pharmaceutical manufacturingTumble blenders deliver highly accurate and repeatable mixing of powders, granules and even low-viscosity slurries. In addition, this style blender enables complete discharge and easy cleaning. This bulletin presents some design considerations for maximizing mixing efficiency in a tumble blender and selecting the most suitable features for a particular application.
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Determination of Related Substances in Pemetrexed Disodium (Form-IV) in Bulk Drug Samples by HPLCThe authors describe the development of a stability-indicating reverse-phase high-performance liquid chromatographic (RP?HPLC) method for the quantitative determination of potential genotoxic impurities present in pemetrexed disodium (form-IV). The chromatographic separation was achieved on a RP?HPLC column (Zorbax SB-Phenyl, Agilent) at ambient temperature with gradient elution using mobile phase A (trifluoroacetic acid [TFA] in water) and mobile phase B (TFA in acetonitrile).
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Creating a Successful Partnership with a Contract ManufacturerEffective partnerships between research and manufacturing operations can streamline the process of bringing a product to market.
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Selecting Lactose for a Capsule-Based Dry Powder InhalerDry powder inhalers are a well-accepted dosage form for pulmonary drug delivery and a wide variety are either currently available or in development. This article examines a premetered, capsule-based multidose inhaler for which different qualities of a-lactose monohydrate were screened.
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Capsule-in-Capsule TechnologyThe author outlines how to choose carriers and capsule shells according to dosage requirements and intended use. This article is part of a special Drug Delivery issue.
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Manufacture and Dissolution Studies of Lipid Spheres: Part IIPrevious articles have presented a general review of the different types of spheres that can be obtained using a rotary fluidized bed process.1,2 Part I of this study focussed on lipid spheres prepared using hydrogenated castor oil for formulations with low active drug content. The feasibility of the process and the main characteristics of spheres obtained were also studied. In Part II, formulations with higher concentrations of active drug are examined.
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How Excipient Supplier Certification Helps Pharmaceutical Supply Chain in EuropeThe EXCiPACT Certification Scheme ensures patient safety through supplier quality while minimising the audit burden and overall costs for assessing the excipient supply chain.
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Polymers for Solubility EnhancementNew chemical entities with poor aqueous solubility require the use of technologies to enable sufficient oral bioavailability of these NCEs following administration.
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Erythritol: A New Multipurpose ExcipientErythritol is a bulk sweetener polyol that is suitable for a variety of reduced-calorie and sugar-free foods. It has been part of the human diet for thousands of years because of its presence in foods such as fruit, mushrooms and fermentation-derived products including wine, soy sauce and cheese. This article investigates the properties of erythritol and describes how it can be used as a pharmaceutical excipient.
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Overcoming Common Lyophilization Scale-Up IssuesThe same recipe obtained in laboratory-scale equipment cannot, without modifications, generally be used to freeze-dry the product in a pilot-scale or industrial-scale freeze-dryer.
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Large Industry Cross-Section Contributes to PDA Quality Metrics RecommendationsPDA works with FDA to create pharmaceutical quality metrics.
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Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.
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Best Practices in Adopting Single-Use SystemsBioprocessors should understand the key factors associated with implementing single-use components or platforms, which include materials of construction, components, system design, and vendor support.
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Through-Vial Impedance Spectroscopy: A New In-Line Process Analytical Technology for Freeze DryingA new process analytical technology based on impedance spectroscopy has potential applications for characterizing product attributes during the freeze-drying process.
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Do emerging markets provide the answer to the pharmaceutical industry?The emerging markets represent an attractive investment opportunity for the pharmaceutical industry because of the countries' growing economies and unmet medical needs.
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Helium Integrity Testing of Single-Use VesselsThe rapid uptake of single-use vessels for use in bioprocessing applications has made assuring integrity that much more crucial; helium integrity testing can be used to test integrity and prevent failures.
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The Neglected Pharmaceutical Supply ChainsIncreased competition, industry consolidation and proliferation of products are just a small number of factors putting pressure on pharmaceutical companies to change their traditional business methods. There is a growing focus on improving supply chain efficiencies as a means of optimizing operating margins and financial performance. This article outlines three supply chain types, all of which are identifiable by their product delivery time requirements, which may help pharmaceutical companies streamline supply chain processes and reduce costs.
