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Biologic Standards in the Pharmacopoeias: An UpdateAwareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.
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Biologic Standards in the Pharmacopoeias: An UpdateAwareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.
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Supply-Chain Security from a European PerspectiveGlobal harmonisation would help improve supply-chain security and reduce the flow of falsified and sub-standard medicine into Europe.
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In-line Laser Marking of Silicone TubingPharmaceutical companies require marked components for lot traceability but problems occur within secondary processing and with traditional printing methods.
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Risk-Based Intermediate Precision Studies for Analytical Procedure ValidationValidation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.
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Risk-Based Intermediate Precision Studies for Analytical Procedure ValidationValidation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.
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Risk-Based Intermediate Precision Studies for Analytical Procedure ValidationValidation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.
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Automation on Display at Healthcare Packaging ExpoAutomated fill/finish and inspection equipment displayed at the 2019 Healthcare Packaging Expo improves quality and efficiency.
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Uncovering Hidden Risks in Solid-State API PropertiesAn understanding-during early development-of the solid form landscape of an API can enhance product quality and manufacturing processes.
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Planning a Successful API Procurement StrategySourcing hard-to-find ingredients and establishing a reliable supply chain can stretch the resources of a small- to mid-size pharma company.
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Planning a Successful API Procurement StrategySourcing hard-to-find ingredients and establishing a reliable supply chain can stretch the resources of a small- to mid-size pharma company.
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Planning a Successful API Procurement StrategySourcing hard-to-find ingredients and establishing a reliable supply chain can stretch the resources of a small- to mid-size pharma company.
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Getting in Touch with New Guidance on Topical ProductsChanging regulatory guidance on generic topical products is expected to lead to an increase in the number of market approvals in the near future.
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Using Software in Process ValidationSoftware systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.
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GalenIQ™ - The sweet filler - binderBENEO is a division of the Südzucker Group, that employs more than 1000 people and has production units in Belgium, Chile, Germany and Italy.
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Solving Pharma’s Quality Unit Identity Crisis483s and Warning Letters Point to Inadequate Quality Oversight
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Lessons from FDA 483s and cGMP Inspection DataProduction and process controls, organization and personnel were the top problems found, while packaging and labelling citations increased in 2017 and 2018.
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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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Optimizing Manufacturing Based on the Storage Stability of Pegylated ProductsResearch into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.
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Optimizing Manufacturing Based on the Storage Stability of Pegylated ProductsResearch into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.
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Optimizing Manufacturing Based on the Storage Stability of Pegylated ProductsResearch into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.
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DWK Life SciencesDWK Life Sciences, represented by SciLabware (a wholly owned company of DWK Life Sciences), manufacture and supply a complete portfolio of standard and bespoke primary packaging solutions and services that meet and exceed the rigorous requirements and expectations of our customers. From tubular glass vials, stoppers and caps for lyophilisation and diagnostic kits, glass tubes and caps for control reagents, dropper bottles, with dropper assemblies or tips and closures for blood grouping reagents and rare antisera, to additional services including depyrogenation, particulate cleaning and barcoding, we can offer our customers a full primary packaging solution, received ready to use.
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Replacing Settle Plates with Active Air SamplingJoin this discussion with experts about implementing active air microbial monitoring in sterile cleanrooms. Learn about changes that can save time and money and reduce the risk of product contamination. Live: Wednesday, Nov.13, 2019 at 10am EST | 9am CST | 3pm GMT | 4pm CET On demand available after airing until Nov. 13, 2020 Register free
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The Essential Guide: Cleanrooms and Clean AreasAt Rite-Hite, we have many solutions for the pharmaceutical industry along with the knowledge and experience to help you address the issues you face with your clean areas. We keep up-to-date on best practices, new design and technology, and the latest trends in the industry.
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Troubleshooting Problems Affecting Tooling During Tablet ManufactureUnderstanding difficulties that can occur during manufacture and resolving them quickly can improve oral solid-dosage drug production.
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Modular Approaches to Pharmaceutical Containers Solve Unique ChallengesAdvanced packaging requirements for parenteral drugs are being met with highly tailored solutions.
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Monitoring of transdermal drug delivery in skin using the Renishaw Biological AnalyserDetecting the presence and depth of penetration of drug compounds in skin can prove challenging, current technologies fail to achieve adequate penetration through layers of dermal tissue. In this study, Raman spectroscopy using the Renishaw Biological Analyser - RA816 confirmed the presence of a topical compound in the epidermis and reticular dermis with high specificity and sensitivity.
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A Systematic Approach to Tech Transfer and Scale-UpOnly careful planning can prevent problems that stem from differences between a sponsor’s and a CDMO’s equipment, practices, and culture. This article highlights best practices and case studies.
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Spray drying for enhancing the solubility of poorly soluble drugsSpray drying continues to gain importance as a preferred manufacturing technology for amorphous solid dispersions (ASD). A fast carrier selection allows for a more targeted development process with reduced time to market. EUDRAGIT® polymers have not only been proven to be superior with respect to ASD formations but can also stabilize the amorphous state of the API over storage.
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Spray drying for enhancing the solubility of poorly soluble drugsSpray drying continues to gain importance as a preferred manufacturing technology for amorphous solid dispersions (ASD). A fast carrier selection allows for a more targeted development process with reduced time to market. EUDRAGIT® polymers have not only been proven to be superior with respect to ASD formations but can also stabilize the amorphous state of the API over storage.
