Authors
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Industry 1VQ Solutions: Changes That Bring an Additional Restriction on the Product Compared to Registered ConditionsA case study discussing why post-approval changes present a very low risk, and therefore can be downgraded from a prior-approval to a notification after implementation and managed in the PQS with immediate implementation effect.
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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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The Need for Speed: How Operation Warp Speed Shifted the Pharma IndustryA new focus on speed to market creates challenges for facility design and construction.
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Accelerating Project Delivery with a Lean Alternative to DBBLean delivery offers a promising solution to supply and manufacturing bottlenecks by integrating project teams early on and widening the team’s field of view.
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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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Put a Cap on CAPAsData may be used to improve (or remove) a corrective action/preventive action.
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Improving Tablet Quality with Compression to Equal Force TechnologyTraditional tablet presses do not measure tablets' tensile strength, yet this characteristic strongly influences tablet quality. The author describes a compression technique that accounts for tensile strength and produces tablets with consistent weight and disintegration time.
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Adaptable Formulation Development Strategies for Today with a Focus on TomorrowWesley Tatum, PhD (Principal Engineer, Process & Product Development, Serán Bioscience) shares insights surrounding formulation and process development that focus on the future of the industry.
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Reducing Packaging Costs for Prefilled SyringesBlow-fill-seal (BFS) technology presents an economical option for single-unit dose delivery of vaccines.
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Fabrication Modulation of Zein-based Fibers for Oral Delivery of HydrochlorothiazideThis study suggests that using a simple centrifugal method can produce a natural polymer-blend molecule that can successfully be used as an oral delivery mechanism for poorly soluble drugs.
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Reinvesting in European ManufacturingCOVID-19 has brought to light the issues of European manufacturing capabilities, leading industry to question whether it is now time to reinvest in domestic medicines supply.
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Pushing the Boundaries: Overcoming Formulation and Manufacturing Challenges in Today's Pharmaceutical Development LandscapeAs molecules grow more complex, drug developers in the pharma landscape face an increasing number of challenges in formulation, manufacturability, and sustainability. Fortunately, novel formulation strategies and technologies are reshaping drug development, from overcoming oral solid dose (OSD) challenges to advancing bioavailability and redefining traditional drug-likeness criteria.
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Inside USP: USP Metals Testing: A Workshop ReportAttendees at a recent workshop endorsed new methods to detect metals in drugs, dietary supplements, and food ingredients.
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Strong Quality Culture: A How-To for Busy ManagersBuilding employee participation and forming good habits contribute to a company-wide quality culture that pays off.
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How To Identify The Right Outsourcing Partner In Asia–PacificHow to find the right partner in Asia–Pacific is a very complex question and there is no uniform answer.
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EPCAM: A Strategy to Enable Manufacturing-Process Control TransformationEnterprise process control and management (EPCAM) is a new strategy for healthcare manufacturers based on recent process-control breakthroughs in the electronics industry.
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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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Supplementary Handwashing Techniques to Improve Hand HygieneA fluorescence test method was used to visually evaluate handwashing efficacy. Difficult-to-clean areas on skin such as skin folds and webbing between fingers were identified; specific washing techniques to address problem areas are proposed.
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Rapid Sterility Methods for CAR T-cell TherapiesA combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.
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Capping and Manufacturing Strategies for Increasing mRNA Potency and Reducing CostsIn vitro transcription (IVT) is often used to make mRNA, and in co-transcriptional capping an analog cap can be used to cap the mRNA. This paper reviews the recent history of capping analogs in addition to a state-of-the-art approach to improve protein expression.
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Transforming CDMO partnerships through qualityThis whitepaper explores the criteria for defining true quality in a CDMO partnership, including multiple product, process, and relationship variables
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Revolutionizing Biomanufacturing: The Digitalization AdvantageDigital transformation allows for smarter and connected biomanufacturing operations.
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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.
