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Pharma Services Sector Poised for Continued Growth and ConsolidationThe CRO market will see greater consolidation by both financial buyers looking to consolidate smaller players and larger CRO players wanting to expand into value-added specialty service areas.
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Trends in International Arbitration: The Fallout from COVID-19As a result of the disruptions caused by the COVID-19 pandemic, global arbitration has adapted to a ‘new normal’.
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FDA Presents: Ophthalmic Generic Drug Development and Approval: Challenges and Recent ResearchThursday, August 5, 2021 at 11am EDT| 8am PDT| 4pm BST|5pm CEST
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Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in BiomanufacturingDetermining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.
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Nanotechnology: A lifeline for drying pharma pipelines?Pharmaceutical Technology Europe spoke with experts about the developments that have shaped the nanotechnology industry today and the benefits that this technology has to offer the pharmaceutical industry, which remain largely untapped.
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Nanotechnology: A lifeline for drying pharma pipelines?Pharmaceutical Technology Europe spoke with experts about the developments that have shaped the nanotechnology industry today and the benefits that this technology has to offer the pharmaceutical industry, which remain largely untapped.
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Development of Orally Disintegrating Tablets Based on a New ExcipientThe authors examine the effectiveness of an excipient comprised of mannitol, polyvinyl acetate, and crospovidone using model actives loperamide hydrogen chloride and caffeine.
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Analytical Strategies for Cell and Gene Therapy DevelopmentDeveloping bioassay methods requires a new approach for cell and gene therapy drug development.
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Demystifying Complex Clinical Trial Kit PreparationBest practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.
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Development of a Validated Method of Testing for NDMA in RanitidineThis article describes a validated method, using liquid chromatography/mass spectrometry, for detecting the carcinogenic impurity NDMA (N-nitrosodimethylamine) in ranitidine that meets and exceeds FDA’s limit of detection and limit of quantitation requirements.
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Continuous Inline Size Monitoring of Low Turbidity NanosuspensionsFind out how the NanoFlowSizer’s THALIA system is capable of measuring particle size in continuous liposome manufacturing with low lipid concentrations, below 3 mg/mL.
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Assessing Legacy Drug QualityA data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.
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Novel Formulations and Line Extensions with Soft Capsule TechnologyAdvancements in soft capsule technology can enable the development of soft capsule formulations, which are becoming the preferred method of oral administration.
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Embracing Agile Methodology for E&L ExcellenceDelivery of robust E&L programs by leveraging Agile software development methodologies in the laboratory.
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Viewpoint: Digitizing Processes to Align with GMP RequirementsThe case for migrating from a paper-based quality management system to a digital platform is presented.
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Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug DevelopmentExtrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.
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EU Anti-Counterfeiting Legislation On Its WayIn order to combat the threat of counterfeits in Europe, the EU's current anti-counterfeiting directive is being amended.
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Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
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Inhaled Biologics from ZeroExperic’s latest article looks at new initiatives aimed at fostering the development of biologics delivered via inhalation, an emerging field. While manufacturing technologies have advanced to support this sector, several challenges remain, including an unclear regulatory pathway.
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Trends: Holograms and AnticounterfeitingSophisticated replication techniques have made counterfeiting and fraud a serious threat to the pharmaceutical industry.
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The New Digital Era for Formulation DevelopmentA new generation of interactive formulation development platforms can leave trial and error in the formulation process in the past.
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Using Robotics in the Aseptic Manufacturing Facility of the FutureSeveral steps need be taken to achieve lights-out, fully automated operations.
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Master File Submission of StructuresThe SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.
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Technology Forum: The Next Steps for Pharma Manufacturing Efficiency and EffectivenessWednesday, September 15, 2021 at 10am EDTDrug manufacturing demands and increased regulatory oversight are prompting pharmaceutical manufacturers to consider new processes for oral solid dose and aseptically processed drugs. A cross-section of industry experts will offer insight on emerging trends, technologies, and processes in this Technology Forum.
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True Biosimilars Do Not Offer A Compelling Business CaseWhy the primary defence against biosimilars is to develop better molecules that can be launched quickly.
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The versatility and value of liquid-filled hard capsulesThis article discusses the benefits and advantages of liquid-filled hard capsule manufacturing from formulation, development and full-scale production
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Delivering on the Potential of mRNA TherapeuticsThe complexity of the RNA production process creates challenges.
