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Ecolab Continues Mission to Protect What's Vital With Deep Investment in Life SciencesEcolab is looking to the future with new opportunities to partner with Pharma for critical solutions to support drug development and manufacturing.
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Nephron Pharmaceuticals Integrates STERIS VHP Biodecontamination SystemThis case study examines the benefits and challenges Nephron Pharmaceuticals Corporation faced integrating a STERIS VHP® Biodecontamination system into their high-volume compounding facility.
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A Systematic Evaluation of Risks and Mitigation Strategies for Convalescent Plasma Therapy for COVID-19A task force details its findings of the risks associated with using convalescent plasma using failure mode and effects analysis
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Purification of Antibodies Using Novel Convecdiff Membranes Part 2: Robust Performance at Comparable Product QualityIn part 2 of this article, results from the testing of a next generation convecdiff membrane are discussed.
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The Importance of Process Intensification and PAT for Achieving Real-Time ReleaseCreativity and collaboration are required to overcome complex method development challenges.
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Streamlining MS-based Analytics for the Investigation of In Vivo Biotransformation of BiotherapeuticsWebinar Date/Time: Thu, Jun 20, 2024 10:00 AM EDT
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Fouling Mechanisms of Filters During the Harvest Development of Monoclonal Antibody Therapeutics with Intensified Upstream Processes—Part 2The authors evaluated the potential of direct filtration for multiple biopharmaceutical candidates. This article is Part 2 of the study.
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The Quest for Quality: Challenges and Strategies in Raw Material Selection for BiopharmaceuticalsBiopharmaceutical production faces the challenge of ensuring the quality of raw materials due to a lack of specific guidelines. By implementing effective risk assessment strategies and working with reliable, selected solution providers, biopharmaceutical manufacturers can minimize these challenges and improve product quality.
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Continuous Preparative SEC for Purification of “Difficult-to-Manufacture” Proteins–A Feasibility StudyContinuous SEC was shown to increase productivity with the same product quality and yield.
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Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based StrategiesMany biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.
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Demystifying Complex Clinical Trial Kit PrepBest practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.
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I Saw the Future of Global Pharmaceutical Production in IndiaGuest contributor Frederic Kahn discusses the state of the Indian pharmaceutical manufacturing industry.
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“P.E.R.F.E.C.T.” the Packaging Selection ProcessA step-by-step path to building confidence in packaging component selection for injectable drugs
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Gene and cell therapy analytical and development methods: A path to successProcess development methods & analytical requirements are integral parts of gene therapy manufacturing. This whitepaper explores the analytical and development approaches needed for success.
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Detecting Residual HCPs Demands a Holistic ApproachGene therapy products present a unique set of challenges for the control of host cell protein 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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A New Era of Biomarker Discovery: Harnessing the Clinical Power of AI-Driven GlycoproteomicsAssessment of peripheral blood protein glycosylation has recently become scalable, providing a new domain for biomarker research.
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Purification of Protein by HIC: Mechanistic Modeling for Improved Understanding and Process OptimizationIn this article, a simple chromatographic model is proposed that is capable of predicting the impact of pH and ionic strength on HIC chromatograms.
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Perfecting the Pitch: Learning to Attract Investor FundingStart-ups are plagued with common issues that dramatically decrease their odds of achieving investor funding.
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A Systematic Evaluation of Risks and Mitigation Strategies for Convalescent Plasma Therapy for COVID-19A task force details its findings of the risks associated with using convalescent plasma using failure mode and effects analysis
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Addressing Cell Therapy Challenges Through a Modular, Closed, and Automated Manufacturing SystemScaling cell therapy production workflows requires the establishment of closed, automated steps.
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Continuous Preparative SEC for Purification of “Difficult-to-Manufacture” Proteins–A Feasibility StudyContinuous SEC was shown to increase productivity with the same product quality and yield.
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Using Anion Exchange Membrane Adsorbers to Ensure Effective Virus Clearance of Challenging ParvovirusesA series of minute virus of mice spiking studies were performed with a monoclonal antibody product and small-scale AEX membrane adsorbers to evaluate a range of critical processing conditions.
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MHC-Associated Peptide Proteomics: Immunogenicity and Vaccine DesignThis article looks at how the MAPPs assay works, how it integrates with other immunogenicity assays, and just how it can be flipped to help in vaccine design.
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The Optimal Metric of Space-Time YieldSpace-time yield is a critical metric for comparison of upstream biomanufacturing processes and can be useful in reducing commercial production costs.
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Industry 1VQ Solutions: Change of Lot or Extension of Shelf-life of Reference StandardChange of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.
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The First Optimized Self-Replicating RNA (srRNA) TechnologyThis inaugural edition of the Pivotal Paper series features leading vaccine experts discussing a groundbreaking study on next-generation self-replicating RNA (srRNA) vaccine technology. The panel explores the study’s key findings, highlighting srRNA’s potential for lower-dose, single-dose vaccines with enhanced immune response, expanding the applications beyond infectious diseases.
