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Implementing Data Integrity Compliance in a GLP Test FacilityConsider how to apply ALCOA+ to a building management system in non-clinical laboratories.
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Is Pharma Doing Enough To reduce The Environmental Impact Of packaging?Generally, the pharma industry isn't doing enough to reduce the environmental impact of its packaging materials, but there are various historic reasons for this.
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Perspectives and Challenges of Nanomedicine in Gene SilencingAdvances in nanomedicine have provided several potential candidates for safe and effective delivery of siRNA.
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Designing Incubators for Cell Therapy ManufacturingControlling conditions and preventing contamination are crucial for cell growth.
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PharmaLex furthers its clinical and regulatory reachMerger with Phlexglobal expands provider’s technological capabilities.
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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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Global Organization, Local PresenceDiscover Fedegari’s Local Expertise with Global Reach. Fedegari combines global manufacturing excellence with local service agility to deliver high-quality, responsive support across North and South America. Learn how our strategic presence and expert teams help pharmaceutical companies optimize sterile process solutions.
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Advancing Detection of Unknown ImpuritiesHaving intelligent analytical tools can advance the detection of unknown impurities, which is important for ensuring small-molecule ingredient purity.
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A Harmonized Approach to Performing a Risk-Based Audit Trail ReviewThe IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
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Aseptic Processes Safeguard BiologicsAseptic techniques must be practiced throughout all stages of biologics production.
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A Guide That PerplexesDespite its flaws, a recent release fills a need for books about pharmaceutical project management.
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Shining a Light on the Long Shadow of Subjectivity in Quality Risk ManagementThis article explores the emergence of subjectivity in ICH Q9 (R1).
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Data sharing more efficient with purpose-built LIMSA laboratory information system (LIMS) is a key tool in facilitating communication between a pharmaceutical company and its outsourcing partners; however, most LIMS require extensive customisation before they can be used in the pharmaceutical industry.
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Rare Ability: US-Based CDMO Has Available Fill/Finish Capacity, Development & TestingDiscovery the industry's best kept secret...a fast-growing, end-to-end CDMO service provider in Nashville, TN that offers development, testing, and fill/finish cGMP manufacturing for sterile injectable and topical products – all under one roof. Whether your drug product is liquid or lyo, aseptically filled or requires terminal sterilization, the August Bio team brings to bear more than two decades of drug development and launch expertise. Supporting projects from preclinical to clinical to commercialization and with new multiple high-speed filling lines (vials, syringes, IV bags), August Bio also offers the rarest of CDMO attributes today - immediate, available capacity.
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Process Patent Protection: Characterizing Synthetic Pathways by Stable-Isotopic MeasurementsThe authors describe the methods by which precise analyses of stable-isotopic abundances can be used in security and forensic applications for pharmaceutical materials. These methods include product and process authentication of raw materials, pharmaceutical intermediates, drug substances, formulated drug products, and synthetic pathways. Collectively, these methods can be used to investigate and mitigate patent infringement. In the future, more complete examples will be presented containing full isotopic results and the application of the methods described in this article.
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Industrial Applications of Whole-Cell BiocatalysisRecombinant microbial whole-cell biocatalysis is a valuable approach for producing enantiomerically pure intermediates. The authors examine several groups of enzymes using this approach: dehydrogenases, hydantoinases, and acylases.
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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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Evaluating the Impact of Fatty Alcohols on Permeation of Clotrimazole from Topical CreamsStudy results indicate that fatty alcohols may plausibly enhance the skin permeation of clotrimazole.
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Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in BiomanufacturingDetermining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.
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Capturing The Advantages Of Co-CrystalsHow can crystal engineering and pharma sciences be combined to enhance the clinical performance of drugs?
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Variables Affecting Reconstitution Time of Dry Powder for InjectionThe authors describe the factors affecting reconstitution time of dry powder for injection and classifies them as intrinsic and extrinsic parameters.
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At DCAT With Piramal Pharma SolutionsPeter DeYoung, CEO, Piramal Pharma Solutions, talks about recent company achievements and key offerings, as well as current industry trends.
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Is Real-Time Release Through PAT Compatible with the Ideal of "Science-Based Regulation?"The role of micro-biological testing in real-time release is too important to ignore.
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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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Overcoming Engineering Challenges to Enable Commercial Scale mRNA Vaccine ManufacturingThis article provides an overview of solutions to address key challenges facing vaccine developers or CDMOs wishing to build their own commercial-scale mRNA production facilities.
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Navigating International PharmacovigilanceInternational pharmacovigilance for biotechs brings about a particular set of challenges, especially for small companies, which face the same rigour as large pharma companies.
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Automating Glycoprotein Analysis for Vaccine ManufactureOne can improve method precision and productivity by replacing one step in sample preparation with an automated approach.
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Scale-up and Tech Transfer: From Development Lab Studies to Commercial ProductionAdherence to detail and thorough project management are required for successful tech transfer and scale up.
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The Value of Pharmacopeial Reference StandardsThis article provides an overview of the key risks that can be associated with the use of secondary reference standards (RS) and illustrates scientific challenges associated with transitioning from pharmacopeial RS to secondary RS.
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Nanoparticles for Drug DeliveryOn Demand Webcast Nanoparticles have unique properties that are manipulated to create novel solutions, such as innovative drug delivery systems seen in today’s Covid-19 mRNA vaccines. This webinar explores the analytical techniques used for nanoparticle characterization and its growing significance in drug delivery systems.
