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Time to GAIN: Are Your FDA Marketing Exclusivities Eligible for Extension?Pharmaceutical companies should consider what is required for QIDP designation and whether they can use it to extend the protection afforded to their innovative products.
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Using Process Capability for Statistical Evaluation of Cleaning ProcessesThis study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning.
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Using Process Capability for Statistical Evaluation of Cleaning ProcessesThis study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning.
Latest:
Using Process Capability for Statistical Evaluation of Cleaning ProcessesThis study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning.
Latest:
Using Process Capability for Statistical Evaluation of Cleaning ProcessesThis study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning.
Latest:
Using Process Capability for Statistical Evaluation of Cleaning ProcessesThis study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning.
Latest:
Using Process Capability for Statistical Evaluation of Cleaning ProcessesThis study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning.
Latest:
Using Process Capability for Statistical Evaluation of Cleaning ProcessesThis study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning.
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Developing New Mass Spectrometry Solutions: From Individual Membrane Protein Complexes to In-Vivo Proteome DynamicsHigh speed MALDI mass spectrometry instrumentation drives multidisciplinary membrane proteomics research.
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Developing New Mass Spectrometry Solutions: From Individual Membrane Protein Complexes to In-Vivo Proteome DynamicsHigh speed MALDI mass spectrometry instrumentation drives multidisciplinary membrane proteomics research.
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An Integrated Approach to Shipping Liquid in Single-Use SystemsIncreased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. This article provides qualification data under international ASTM D4169 norms.
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An Integrated Approach to Shipping Liquid in Single-Use SystemsIncreased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. This article provides qualification data under international ASTM D4169 norms.
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Impact of Agitator Design on Bioreactor PerformanceAerobic bioprocesses are highly dependent upon the oxygen transfer rate (OTR) from sparged to dissolved gas. The relatively low solubility of oxygen, however, makes the choice of mixer impeller configuration a critical design factor for the bioreactor vessel. This article describes a series of experiments and computational fluid dynamics (CFD) simulations to detail the effect of mixer configuration on the efficiency and effectiveness of a bioreactor vessel with respect to blend time and mass transfer.
Latest:
Impact of Agitator Design on Bioreactor PerformanceAerobic bioprocesses are highly dependent upon the oxygen transfer rate (OTR) from sparged to dissolved gas. The relatively low solubility of oxygen, however, makes the choice of mixer impeller configuration a critical design factor for the bioreactor vessel. This article describes a series of experiments and computational fluid dynamics (CFD) simulations to detail the effect of mixer configuration on the efficiency and effectiveness of a bioreactor vessel with respect to blend time and mass transfer.
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Drug Discovery and Development in IndiaHope abounds for local drug discovery companies despite challenges at home.
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The Evolving War on Drug PricesImmuno-oncology drugs are demonstrating patient benefits, but growing resistance to the high cost has implications for patients, market access, and manufacturers.
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Value-Based Healthcare in the: United KingdomBio/pharmaceutical manufacturers in the UK face challenges in proving that their drugs are worth the price.
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Pre-use Filter-Integrity Testing: To Test or Not To Test?There is no harmonized guidance on pre-use integrity testing of sterilizing filters, prompting discussion among users as to whether such testing is necessary.
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Ready-to-Use Parenteral Packaging Components Address Evolving Aseptic Fill/Finish RequirementsReady-to-use components eliminate the need for component preparation by the drug product manufacturer, enabling them to streamline their processes and focus on their core competencies, such as drug product development and manufacturing.
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Relevance RegainedCompanies risk drowning in alphabet soup if the latest three-letter acronym improvement strategy isn't clearly linked to business strategy.
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Finding Opportunities in BrazilChanges in the country’s political landscape may affect the pharmaceutical industry market in the future.
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USP Workshop Focuses on BiologicsThe workshop focused on topics specific to biologics, including particulate control and determination, becoming the first workshop of its kind for the organization.
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Identification and Quantification of Trace-Level Protein ImpuritiesThe authors discuss the development of a simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics.
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Identification and Quantification of Trace-Level Protein ImpuritiesThe authors discuss the development of a simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics.
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Identification and Quantification of Trace-Level Protein ImpuritiesThe authors discuss the development of a simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics.
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Identification and Quantification of Trace-Level Protein ImpuritiesThe authors discuss the development of a simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics.
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Modular Facility Design Maximizes Space FlexiblyVetter's FOYA award-winning facility is an example of a flexible pharmaceutical and biopharmaceutical modular facility design that allows expansion of space without affecting existing operations.
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The Future of Dosage FormsHow will the move to more specialized and personalized medicines impact drug delivery and dosage forms?
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USP Workshop Focuses on BiologicsThe workshop focused on topics specific to biologics, including particulate control and determination, becoming the first workshop of its kind for the organization.
