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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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Drug Digest: From Theory to Reality: Automating Process DevelopmentIn this episode of Drug Digest, industry experts discuss the ongoing development of automating biomanufacturing processes, including its challenges and practical applications.
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AQbD, the Evolution of Pharmacopoeial Standards?MHRA has launched a consultation to gain a greater understanding of the potential application of AQbD in pharmacopoeial standards and the future of medicines standards.
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AQbD, the Evolution of Pharmacopoeial Standards?MHRA has launched a consultation to gain a greater understanding of the potential application of AQbD in pharmacopoeial standards and the future of medicines standards.
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Designing Phase-Appropriate CMC Analytical ProgramsA one-size-fits-all strategy is not the best approach for the development of a chemistry, manufacturing, and controls program.
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Best Practices in the QC Micro LaboratoryStrong personnel training, detailed SOPs, commitment to data integrity, investigation and implementation of appropriate modern methods, and employing Lean and Six Sigma methodology initiatives are key best practices for the quality control microbiology lab.
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De-risking Biologics Development Through Advanced Mass Spectrometry ApproachesAdvanced HDX-MS and native MS techniques can be used to improve the identification of potentially successful biologic drugs and take the risk out of CMC and clinical designs.
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Quantitation of Mutagenic Impurities in APIs Using a Platform Chip-Based CE–MS MethodThe ZipChip CE-ESI interface was evaluated for suitability as a platform approach for quantitation of MIs in API.
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Quantitation of Mutagenic Impurities in APIs Using a Platform Chip-Based CE–MS MethodThe ZipChip CE-ESI interface was evaluated for suitability as a platform approach for quantitation of MIs in API.
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Quantitation of Mutagenic Impurities in APIs Using a Platform Chip-Based CE–MS MethodThe ZipChip CE-ESI interface was evaluated for suitability as a platform approach for quantitation of MIs in API.
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Quantitation of Mutagenic Impurities in APIs Using a Platform Chip-Based CE–MS MethodThe ZipChip CE-ESI interface was evaluated for suitability as a platform approach for quantitation of MIs in API.
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Quantitation of Mutagenic Impurities in APIs Using a Platform Chip-Based CE–MS MethodThe ZipChip CE-ESI interface was evaluated for suitability as a platform approach for quantitation of MIs in API.
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Quantitation of Mutagenic Impurities in APIs Using a Platform Chip-Based CE–MS MethodThe ZipChip CE-ESI interface was evaluated for suitability as a platform approach for quantitation of MIs in API.
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Best Practices for Selecting a Service ProviderKey considerations when searching for an analytical service provider include workflow, hardware, and regulatory support.
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Why Dread Your Next FDA Inspection?Performing a compliance gap assessment and focusing on six key factors in your facility’s process definition and controls can help your facility pass its next FDA inspection with flying colors.
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Overcoming The DistanceWith the Western world recovering slowly from a recession, and tighter restrictions for medical products being applied by the FDA and other regulatory authorities, more medical device R&D is being located in Asia.
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Implantable Systems and Microparticle Depots: Meeting the Formulation and Manufacturing Challenges of Long-Acting Drug Delivery“Implantable Systems and Microparticle Depots: Meeting the Formulation and Manufacturing Challenges of Long-Acting Drug Delivery” Interested in learning how depot injections and implantable systems provide tunable delivery that addresses complex solubility, bioavailability, and stability issues? Register for this webinar for a deep dive into long-acting drug products, including guidance on dosage form selection, design choices, polymer options, and manufacturing techniques for depot injections and implantable systems. Learn how critical quality attributes such as in vitro drug release and particle size distribution are measured with real-world case studies. Live: Wednesday, Sept.11, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Sept. 11, 2020 Register free
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Applications in Pharmaceutical ManufacturingThe use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of effectiveness, minimal surface residue, and easier cleaning validation.
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Advancing Injectable Drug Quality: Innovations, Compliance, and Sustainability in the Healthcare IndustryWebinar Date/Time: Tue, Nov 5, 2024 9:00 AM EST
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The Case for Purpose-Built Pharma LIMSLearn how you can bypass lengthy customizations by deploying a purpose-built LIMS. Pre-configured, pre-validated lab information management systems save time and money, reduce risk, keep you focused, and future-proof your lab.
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Containing Cytotoxic Product during TransportThe purpose of this document is to serve as a case study where a containment device was designed to facilitate “interim containment”, or containment during the portion of a process where the product isn’t inside the enclosure.
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Size Doesn’t Matter … Under PressureSimplify the scaling of different dosages. Develop on lower dosage tablets to save money. Decrease the need to have multiple tooling sizes in R&D.
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Annex 1 Considerations for Fill/FinishEquipment and systems for aseptic transfer and manufacture meet cGMP and Annex 1 requirements for pharmaceutical fill and finish.
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How Excipient Type Influences Self-Emulsifying Drug DeliveryHigh-throughput platforms can be used to develop tertiary phase diagrams, which can be leveraged to identify the most stable SEDDS formulations and excipients for lipid-based drug delivery systems.
