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An Alternative Spectroscopy Technique for Biopharmaceutical ApplicationsSpectroscopy using light is a familiar technique and the electromagnetic spectrum from UV to IR is routinely employed. This article looks at the advantages and applications of spectroscopy using sound waves, with special reference to pharmaceutical research.
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Electrodeionization in Pharmaceutical Water TreatmentElectrodeionization units can reduce or eliminate the cost and hazards associated with traditional technologies for producing water intended for use in final drug dosage forms.
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Patents and Postapproval Batch TestingCan postapproval FDA filings immunize pharma companies from patent lawsuits?
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Choosing a Contract Research Organization for Analytical TestingSelection of a contract research organization is a decision that encompasses many key factors. In this article, the author discusses various considerations that surface when selecting and working with a CRO and provides tips for establishing a beneficial relationship.
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Recent Advances in Semisolid Dosage Forms for Dermatological ApplicationSemisolid dosage forms are advantageous in terms of their easy application, rapid formulation, and ability to topically deliver a wide variety of drug molecules.
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Turkey Increases R&D IncentivesLast year, the Turkish Government unveiled plans to position the country in the top 10 most-preferred locations for R&D investment in the pharmaceutical sector by 2023. This article provides an overview of the incentives introduced under the Technopolis Law and the R&D Act.
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Turkey Increases R&D IncentivesLast year, the Turkish Government unveiled plans to position the country in the top 10 most-preferred locations for R&D investment in the pharmaceutical sector by 2023. This article provides an overview of the incentives introduced under the Technopolis Law and the R&D Act.
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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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Bioprocessing Facilities and FDA Inspection ProblemsFDA inspections can create uncertainty. Supervision of the contract manufacturer is crucial in ensuring compliance.
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Challenges and Strategies for the Downstream Purification and Formulation of Fab Antibody FragmentsAntibody fragments pose unique challenges in terms of recovery, purification, and formulation.
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Single-Use Redundant FiltrationThe authors describe a new assembly for bulk and final drug product filling operations.
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Part VII GMPs for Small Molecule Drugs in Early Development Workshop SummaryThe authors explore and define common industry approaches and practices when applying GMPs in early development.
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Are Project Management Services Right for You?Project management services can help companies experience reduced time to market, less costly manufacturing processes, and more efficient information flow.
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New Gene Patent RulesThe US Supreme Court's Myriad decision satisfied both patient groups and patent holders
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E-Validation: A Method for Electronic Validation Protocol Generation, Approval, and ExecutionAn all-electronic validation can provide storage costs savings and ensured document legibility.
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Correlating Product Lifecycle and Manufacturing Site Characteristics with Critical-to-Quality Product DeviationsMIT survey results address product and site characteristics that statistically correlate with quality performance.
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Fixed-Dose CombinationsFixed-dose combinations (FDCs) reduce the number of pills that must be taken, but they have also been a topic of concern, mainly because of the perceived potential for increased adverse events. PTE speaks with researchers to explore the benefits and concerns of FDCs.
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Evaluating Progress in Analytical Quality by DesignThe authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.
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Early Development GMPs for Stability (Part IV)IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.
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The Development of a Floating Drug-Delivery System for MetronidazoleThe authors developed a metronidazole-based floating drug-delivery system to investigate the effect of rate-controlling polymers on release pattern and duration of buoyancy in matrix tablets.
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Correlating Product Lifecycle and Manufacturing Site Characteristics with Critical-to-Quality Product DeviationsMIT survey results address product and site characteristics that statistically correlate with quality performance.
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Early Development GMPs for Stability (Part IV)IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.
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Biosimilar Development: 10 Years OnWith a number of branded biologics hanging at the patent cliff, the future looks promising for biosimilars.
