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Improve Your Efficiency in ProductionExample of how we offer creative and interesting solutions to our customers to improve efficiency in production.
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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.
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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.
