Authors
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Data Integrity: Getting Back to BasicsEnsuring data integrity involves effort on an individual and global basis.
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Drug Shortages and Complying with FDA’s 21 CFR 211.110 GuidanceSusan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
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Defining Risk Assessment of Aseptic ProcessesSusan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
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Utilizing Run Rules for Effective Monitoring in ManufacturingSorendls/Getty ImagesTo maintain a state of control and comply with regulatory authorities, many pharmaceutical, biotech, and medical-device companies have adopted continued pro
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Innovations in Automation—High-Throughput Dynamic Light Scattering for Screening Biotherapeutic FormulationsThis article introduces the technology that powers automated HT–DLS and explores its practical applications in enhancing formulation stability investigations.
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The Benefits of Combining UHPLC-UV and MS for Peptide Impurity ProfilingDetermining a peptide’s purity is challenging because impurities are often structurally similar to each other and the API and can be present at very low concentrations. New approaches offer a solution.
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A Risk-Based Strategy for Implementing Disposables in a Commercial Manufacturing ProcessThe author explores a dual-supplier sourcing strategy for single-use products and its ability to mitigate business continuity risk.
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody ActivitySurface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics.
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Evolving to Meet Industry ChangesIn the development of biopharmaceuticals and pharmaceuticals, the line is blurring.
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Analysis of PEGylated Protein by Tetra Detection Size Exclusion ChromatographyReliably detecting low amounts of high molecular weight impurities during process development and characterization of biopharmaceutical products.
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Top Three Factors That Will Drive Biopharma in the FutureDespite the unpredictability of biopharma, key forces promise to shape the market over the next few years
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Nontuberculosis Mycobacterium Contamination of a Mammalian Cell Bioreactor ProcessThe authors present a case study identifying a contaminant.
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Are Biopharma Patents Poised on the Post-Grant Chopping Block?This article examines trends in biopharma post-grant patent review and projects what the future holds in store.
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Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell LineUse of a subspace model is a viable method to characterize process space variables and optimize process performance.
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Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell LineUse of a subspace model is a viable method to characterize process space variables and optimize process performance.
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Variable Pathlength Fiber-Optic Spectrophotometry for Protein Determination in Immunoglobulin ConcentratesThe authors evaluate the SoloVPE technique as a replacement for nitrogen-based protein determination.
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Variable Pathlength Fiber-Optic Spectrophotometry for Protein Determination in Immunoglobulin ConcentratesThe authors evaluate the SoloVPE technique as a replacement for nitrogen-based protein determination.
