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Contamination Prevention: How Single-Use Systems Can Ensure a Safe, Clean, and Efficient Bioprocess EnvironmentThe authors focus on how single-use systems effectively control three potential sources of common contamination: cross contamination, microbial contamination and biologic contamination of the process facility.
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The New Opportunity in Pharmaceutical Outsourcing: Portfolio MaintenanceFor decades, the power and potential of outsourcing has been viewed as a way for pharmaceutical companies to gain access to specialized domain expertise across geographic regions and achieve cost savings amidst a highly complex and diverse regulatory environment. In the face of dwindling drug pipelines, complex regulations and block-busters crossing their patent exclusivity, mature products offer a revenue stream for companies to sustain their bottom lines in a hyper-competitive global market.
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Wurster Fluid Bed Coating and Contract Development/Manufacturing with Coating Place, Inc.Wurster Fluid Bed Coating is one of the most utilized processes for microencapsulation of fine particles in pharmaceutical, dietary supplement, food, and other industries. Jared McDonald walks through a brief history of the invention of the process, what it is, and how it can be used to address specific needs for a product. A discussion of the importance of choosing an experienced CDMO follows.
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An Intelligent Drug Development ParadigmAn intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.
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Pelletization: Revolutionizing Drug Formulation and DeliveryPelletization, a popular oral drug delivery method in pharmaceuticals and nutraceuticals, offers numerous benefits. This article delves into the critical parameters for formulation development and technological consideration in pelletization, elucidating its significance in advancing pharmaceutical solutions.
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Forecasting Trends in Pharma InnovationIn the coming year, pharmaceutical innovation will be fueled by key trends throughout the quality sector.
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A Discussion: In Vitro Release Testing and Its Application and Use in Generic TopicalLucy Zhou, Skin Lab Manager, discusses the importance and applications for utilizing in vitro Release Testing during development of generic topical drug compounds. Lucy discusses how IVRT can play a critical role by saving cost and time during product development and the techniques and applications for using in vitro testing to achieve desired product outcomes.
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Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical ProductsThis study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.
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An Intelligent Drug Development ParadigmAn intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.
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Enabling the Virtual Human Through Physiologically-based Pharmacokinetic ModelingBasic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed.
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Make Paperless Manufacturing a Reality for your Pharmaceutical FacilityRevolutionize pharmaceutical manufacturing through paperless manufacturing. By eliminating paper-based processes, you can quickly centralize your data, reduce cost and time, minimize errors, and release products faster. Even the simplest “paper on glass” digital systems enable streamlined workflows and can ensure real-time data access and seamless communication. Paperless facilities are a reality! Transform your operations today!
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Control Strategies and Method Development for Nitrosamines in APIs and Drug ProductsWebinar Date/Time: Thu, Nov 7, 2024 9:00 AM PST (12:00 PM EST)
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A Single Adulteration Limit for Cleaning Validation in a Pharmaceutical Pilot-Plant EnvironmentAn adulteration limit of 100 ?g/25cm? (4 ?g/cm?) was proposed for pilot-plant facilities. The dynamic changes in equipment, formulation, and residue determination made implementation of a constantly changing, calculated adulteration limit impractical. A single adulteration limit was simpler to communicate and document, making compliance achievable. The limit would be used only after it was determined to be lower than a health-based evaluation and a visual-cleanliness assessment.
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Nitrosamine Impurities in Medicinal ProductsIndustry should improve the standards on application of risk management tools in light of the cases of nitrosamine impurities.
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Obtaining simultaneous multiple dissolution profiles of solid oral dosage formulationsTesting the dissolution rates of a pharmaceutical formulation (also known as in vitro availability) aids drug quality control and is a compulsory requirement of the British, European and US pharmacopoeias.
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Extractables and Leachables: An Overview of Emerging ChallengesExtractables and leachables are a growing concern for pharmaceutical manufacturers and regulatory bodies.
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Troubleshooting Using Predictive MaintenanceSmart manufacturing transforms management of tablet and capsule equipment and processes.
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Guidelines for Selecting Normal Flow FiltersProper selection of normal flow filters leads to increased process efficiency from early phase product development through to full-scale biopharmaceutical production.
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Seven Trends Shaping the Future of Pharmaceutical Formulation DevelopmentEmerging new technologies and disruptive manufacturing concepts are providing new opportunities for pharmaceutical companies.
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Terminal Sterilization of Sterile Filtered ProductsTerminal sterilization of aseptically processed drug products is extremely important for patient safety. As such, it is a regulatory requirement that drug products that can withstand terminal sterilization be terminally sterilized. Overkill type sterilization cycles are not required for a drug manufacturer to make a terminal sterilization claim. Many different time and temperature combinations that are much more product friendly can be used to safely terminally sterilize drug products.
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In a Digital Gold Rush, Data Integrity is PricelessData integrity is crucial in unlocking novel data-based insights.
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Selecting a CMO Partner for Sterile Injectable Manufacturing (Nov 2023)Vetting a CMO for sterile injectable fill finish means more than capacity and equipment. This white paper from Jubilant HollisterStier discusses the range of factors to consider when outsourcing manufacturing for aseptically filled and terminally sterilized products.
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Reducing Risk With Innovative Surface Cleaning SystemsSean Imlay, FG Clean Wipes, highlights the Saturix® Surface Cleaning System during INTERPHEX 2022. Watch this video to learn more about:
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Solving the Insoluble: Webinar on the Science and Application of the Dispersome® TechnologyWebinar Date/Time: Tue, Nov 12, 2024 9:00 AM EST
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Reshoring Pharmaceutical Manufacturing to the US: Can We Do It?Advanced manufacturing technologies are available, but challenges need to be addressed.
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Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime ProxetilThis study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.
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Understanding the Benefits of Harnessing Just in Time Manufacturing as a Supply Chain Solution for Managed Access ProgramsChallenges that can prevent sponsors realizing the full potential of managed access programs can be overcome by embracing a just-in-time manufacturing strategy.
