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Nitrosamine Impurities in Medicinal ProductsIndustry should improve the standards on application of risk management tools in light of the cases of nitrosamine impurities.
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Inside USP: Metrology and USP DissolutionThe United States Pharmacopeia emphasizes mechanical calibration and a performance test to esnure integrity of the dissolution procedure.
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Viral Vector API Characterization of Product-Related ImpuritiesFDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.
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Tackling Cybersecurity Challenges in Legacy SystemsOngoing and emerging cyber-risks to legacy operational technology systems in bio/pharmaceutical manufacturing must be addressed.
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Overcoming manufacturing and financial challenges of personalized cell therapiesPerson-specific cell therapy could potentially offer a cure as opposed to ongoing treatment, but it is also a disruptive technology that doesn't currently fit into traditional therapeutic manufacturing processes.
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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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Exploring Multimodal Biomanufacturing and Its DriversA combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.
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Assessing the Success of CRISPR Gene Therapies Using ddPCRUsing more exacting analytical tools can give a clearer assessment of gene-editing outcomes.
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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.
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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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Near Infrared Spectroscopy as a Versatile PAT Tool for Continuous Downstream BioprocessingThe need for real-time monitoring and control has spurred the development of new analytical tools.
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The COVID-19 Pandemic and Its Positive Impact on RNA Drug DevelopmentThe COVID-19 pandemic helped to showcase RNA molecules and their therapeutic potential. There were also lessons learned in terms of drug delivery, manufacturing, logistics, and storage.
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The Age of Big Q: A Full Organization Obsession with Customer SuccessQuality is one of the most important components of products in pharmaceuticals. Traditionally, the onus was on the manufacturing function to deliver quality. But what if every single member of the organization was completely focused on customer needs? Big Q, or Quality culture, ensures that quality is up to everyone. DuPont expert will discuss more about how its excipient platform is taking customer cues to implement this total quality focus.
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Design of an Aseptic Process SimulationThe authors suggest a design strategy for an aseptic process simulation that focuses on the basic repeating unit of the process, establishing alert and action criteria for the unit itself, and using worst-case simulations to establish routine operational parameters for the manufacturing process.
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Demystifying Complex Clinical Trial Kit PreparationBest practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.
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Dissolvable Films: Dissolvable Films for Flexible Product Format in Drug DeliveryFor pediatric and geriatric patients, fast-dissolving drug-delivery systems provide an easier way to take medications and vitamins. Oral thin films have evolved to provide systemic delivery of active pharmaceutical ingredients for over-the-counter and soon, prescription drugs. The authors review the practical benefits of dissolvable films, their manufacture, and their market potential.
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Exploring Best Practice Tech Transfer Methods for CGTsBest practice methods for the tech transfer of CGTs can increase process and analytics robustness while remaining scalable.
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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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Development of a Validated Method of Testing for NDMA in RanitidineThis article describes a validated method, using liquid chromatography/mass spectrometry, for detecting the carcinogenic impurity NDMA (N-nitrosodimethylamine) in ranitidine that meets and exceeds FDA’s limit of detection and limit of quantitation requirements.
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Is Collaboration the Key to Accelerating Biotherapeutic Development?Vendors are finding ways to address the increasingly complex analytical challenges in the biopharmaceutical industry to further biotherapeutic development.
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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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Manufacturing Considerations for Sourcing GMP Fermentation ServicesThe authors describe the critical aspects of an ideal fermentation services provider.
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Characterization of the Performance of Bin Blenders-Part 3 of 3: Cohesive PowdersIn this final part of a series of three articles, the results from experiments involving cohesive materials are discussed in terms of mixing performance, agglomerate comminution, and lubrication of powder mixtures.
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Using Quality by Design to Develop Fixed-Dose Combination TabletsIn the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using two-level factorial design.
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Safe, Smart, and Sustainable Packaging for the Healthcare IndustryColbert Packaging specializes in safe, smart, and sustainable paperboard packaging for the pharmaceutical and healthcare industries, differentiating itself through industry-focused investments and a commitment to environmental responsibility.
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Polysorbates: Part(icle) of the Problem?A comparison between polysorbates and HPβCD determines the better stabilizer for biologics formulation.
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Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical ProductsThis study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.
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Master File Submission of StructuresThe SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.
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A throughput benchmarking study of Supor™ Prime filters (July 2024)See how Supor Prime filters performed against two comparable products in filtering fluids with antibody concentrations of 70 g/L to 220 g/L. And be sure to request a sample!
