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Platform-Specific Risk Assessment of SARS-CoV-2 Vaccines Using FMEAAmid the rush for a SARS-CoV-2 vaccine to deal with the COVID-19 pandemic, a robust risk assessment must be conducted, and mitigation strategies applied.
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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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Avoiding the GMP BottleneckBest practices to consider when transitioning from research-grade to GMP-grade materials.
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The Manufacturing Edge on Path to MarketFDA backs the benefits of adopting continuous manufacturing, a strategy which has accelerated approval and launch timelines, and its Emerging Technology Program could be a helpful tool.
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From the Chairman: Technology Advances Foster New TherapiesInnovation drives the development of emerging drug modalities.
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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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Enhancing Process Validation for Sterile Liquid and Freeze-Dried FormsAFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
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Temperature and Relative Humidity Control to Reduce Bioburden in a Closed Cell Processing and Production System without DisinfectantsControlling certain atmospheric conditions in a closed NGI processing chamber can reduce bioburden without disinfectants.
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Technology Forum: The Next Steps for Pharma Manufacturing Efficiency and EffectivenessWednesday, September 15, 2021 at 10am EDTDrug manufacturing demands and increased regulatory oversight are prompting pharmaceutical manufacturers to consider new processes for oral solid dose and aseptically processed drugs. A cross-section of industry experts will offer insight on emerging trends, technologies, and processes in this Technology Forum.
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Digital Transformation in Pharmaceutical ManufacturingLeveraging computerized maintenance management systems software can enhance efficiency, improve quality control, ensure accurate documentation, and strengthen data integrity.
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The Impact of SARS-CoV-2 on Biomanufacturing OperationsThis article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.
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Smoothing the Path to Pharma 4.0: Challenges and SolutionsBy taking a digital maturity-first approach to Pharma 4.0, manufacturers can optimally position themselves for success.
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Reevaluating Cell and Gene Therapy DevelopmentThe industry considers applying automation and digitalization lessons learned during the COVID-19 pandemic to enhance workflows.
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The Ever-Changing World of Extractables and Leachables: Lessons learned and future challengesOctober 4, 2021 at 3pm BST | 10am EST | 4pm CEST Join global industry and regulatory experts as they discuss current hot topics in extractables and leachables (E&L) testing for pharmaceuticals, biopharmaceuticals and medical devices.
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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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Innovations in Downstream ProcessingInnovations in downstream processing accelerate development, enhance efficiency, and promote sustainability.
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How to Evaluate a CDMO’s Commitment to QualityWhat do you need to ask during the vetting and selection process to ensure your clinical or commercial program won’t be derailed by a quality-related problem?
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Prefabricated Modular Construction The Good, the bad, and the Not So ObviousWebinar Date/Time: Tue, Sep 26, 2023 11:00 AM EDT
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Balancing Sustainability and Pricing Pressures in the Pharma IndustryChristine S. Yore of Ecolab discusses products and solutions that help pharmaceutical companies address sustainability and cost challenges, along with other key issues in today’s market.
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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.
