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Role of Particle Morphology on Tablet Dissolution RatesParticle morphology of magnesium stearate, added as an anti-caking agent in a high water‑soluble drug substance, has an influence on the dissolution rate of compressed tablets.
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Role of Particle Morphology on Tablet Dissolution RatesParticle morphology of magnesium stearate, added as an anti-caking agent in a high water‑soluble drug substance, has an influence on the dissolution rate of compressed tablets.
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Bioanalytical Methods to Optimize Drug Development: Hybrid LC-MS vs LBADrs Dawn Dufield and Dominic Warrino, KCAS Bioanalytical and Biomarker Services, share expertise on using Hybrid LC-MS versus LBA for bioanalytical analysis.
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Challenges with Successful Commercialization of BiosimilarsThis article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.
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Challenges with Successful Commercialization of BiosimilarsThis article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.
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Challenges with Successful Commercialization of BiosimilarsThis article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.
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Suitable Sterility Methods for Dimethyl Sulfoxide USP, PhEurDimethyl sulfoxide is increasingly used in high-risk parenteral and medical device applications that must be manufactured as sterile products in their finished form. A study evaluated the effects four sterilization techniques have on the product quality of this ingredient.
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Suitable Sterility Methods for Dimethyl Sulfoxide USP, PhEurDimethyl sulfoxide is increasingly used in high-risk parenteral and medical device applications that must be manufactured as sterile products in their finished form. A study evaluated the effects four sterilization techniques have on the product quality of this ingredient.
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Tips to Manage Temporary Power, Cooling, and HeatingTemporary power, HVAC, and oil-free compressor systems provide flexibility and control for pharmaceutical manufacturing facilities.
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A Study of Leachable Silicone Oil in Simulated Biopharmaceutical FormulationsLeachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.
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A Study of Leachable Silicone Oil in Simulated Biopharmaceutical FormulationsLeachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.
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A Study of Leachable Silicone Oil in Simulated Biopharmaceutical FormulationsLeachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.
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A Study of Leachable Silicone Oil in Simulated Biopharmaceutical FormulationsLeachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.
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A Study of Leachable Silicone Oil in Simulated Biopharmaceutical FormulationsLeachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.
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A Study of Leachable Silicone Oil in Simulated Biopharmaceutical FormulationsLeachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.
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Transforming the Supply Chain with Condition-MonitoringConsiderations for monitoring impact, vibration, and temperature during package transportation and storage.
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Managing water systems with AI and proactive serviceLearn how the application of artificial intelligence (AI) and proactive service helps resolve potential production problems before they occur. This ensures reliable water quality, maximizes uptime, and improves overall production costs.
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Controlled Crystallization During Freeze-DryingThe authors discuss the preparation of lipophilic drug nanocrystals by controlled crystallization during freeze-drying.
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Checklist for Computer Software ValidationNon-compliance issues show that users find dealing with computer systems challenging.
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Applying Operational Excellence to Improve Injectable Pharmaceuticals ProductionUsing Lean, Six Sigma, and other Op Ex practices is helping one contract development and manufacturing organization (CDMO) increase efficiency and optimization.
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JPM CBRN Medical Teams with Janssen Vaccines & Prevention B.V.The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) entered into a Letter of Agreement for Materials and Information Transfer with Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical companies of Johnson & Johnson on October 2, 2019. The Agreement defines assay validation submission protocol and reporting processes to the European Medicines Agency, and potentially other foreign regulatory agencies and authorities, to expedite its review of Janssen’s vaccine. The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), a component of the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemi
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Viatel™ Ultrapure Bioresorbable PolymersViatel™ Ultrapure polymers: High-purity, controlled-release polymers for improved consistency and extended durations in long-acting injectables and implants (LAII). With a proprietary purification process, residual monomer is reduced to <0.5%, ensuring reproducible performance and a more neutral pH environment. These GMP-grade polymers, with typical batch results of 0.1% monomer content, offer formulators greater versatility in addressing complex formulation challenges, reflecting Ashland's commitment to continuous improvement in response to customer needs.
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Quality by Design—a Fundamental Paradigm Shift in Pharmaceutical ManufacturingQuality by Design has initiated a paradigm shift in solid dose pharmaceutical manufacturing.
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Dual Aspects of Informed vs. Explicit Consent in R&DPatient consent is potentially tricky for pharma R&D to navigate as a result of new data protection rules in Europe.
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Sherwin-Williams to Showcase Next-Gen Coatings for Pharma Cleanrooms at INTERPHEX 2025Sherwin-Williams’ advanced coating systems are designed to ensure safety, sterility, and efficiency in pharma manufacturing environments.
