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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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Video – Running samples on Cedex Bio HT AnalyzerMonitoring and controlling your bioprocess just got easier with simplified sample loading. Watch Ryan Lybarger, Senior Field Application Consultant, demonstrate how to analyze substrates, metabolites, product titer, and more.
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Increasing the Depth and Reliability of HCP Analysis Using TIMS-MSSophisticated analytical technologies are complementing traditional approaches in the identification of residual process-related impurities of biotherapeutics.
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7 Key Considerations When Outsourcing the Manufacture of Your Proprietary Media FormulationMany organizations outsource their media manufacturing to a third-party provider when production-scale volumes are needed. How do you know if you’re choosing the right supplier?
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Strategy for Derivation and Optimization of a Clonal HEK293 Suspension Cell Line for High Yield AAV ProductionThis commentary summarizes the derivation of clonal HEK293 suspension cell lines, selection of clones for rAAV production, and design of experiments-based optimization strategies for characterization of one clonal isolate for high yield rAAV manufacture. Data shown provides proof of concept for the success of this strategy, its applicability for manufacturing different rAAV serotypes and lays the foundation of further clonal cell line characterization for scale up of production.
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High-Growth Microbial Fermentation for the Manufacture of BiologicsChallenges in fermentation can be addressed through equipment changes, facility design, and process development.
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Driving Innovation in Nucleic Acid TherapeuticsInnovation in this space depends on strategizing for GMP compliance and market access.
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Do Modeling and Simulation Tools Really Benefit the Biosimilar Industry?The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.
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Selecting and Optimizing the Right Manufacturing PartnerOptimizing the use of partners for clinical trials depends on selecting the right contractor.
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Formulating Autologous Therapies for CancerAutologous tumor cells engineered for immune system stimulation can target unique metabolic, genomic, and phenotypic characteristics of cancer cells.
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Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug DevelopmentExtrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.
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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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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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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.
