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Plasmid DNA—The Versatile Building BlockPlasmid DNA (pDNA) is a critical raw material for the manufacture of cell and gene therapies. As this market continues to grow, so too does the demand for high-quality pDNA.
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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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Mitigating Human Error and Supporting Compliance with Smart TechnologyTechnological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.
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Perceptions and Considerations for Adopting Closed ProcessingThe combination of modular facilities and closed processing offers significant advantages in the production of biopharmaceuticals and is becoming a compelling option for manufacturing.
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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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From Conception to Manufacturing. Accelerating Therapies with CuriaIn this podcast, we will explore the advantages of partnering with a Contract Development and Manufacturing Organization (CDMO) to navigate the journey from molecule conception to clinical trials, including the expertise, experience, and preparedness that a CDMO brings to the table. The audience will gain valuable insights into crucial questions such as the optimal stage in the development process to engage with a CDMO, the necessary preparations for a successful collaboration, and whether a finalized molecule is required to initiate discussions with a CDMO. Join Curia’s Director, Process Development Science, Scott Alderucci, who leads the process development group at Curia, a global CDMO offering CDMO expertise for biologics and small molecules.
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Keeping Up With Emerging Analytical TechnologyThere are several advantages to using a novel capillary electrophoresis-mass spectrometry (CE-MS) device. The REBEL from 908 Devices offers a streamlined and efficient alternative to traditional liquid chromatography-mass spectrometry (LC-MS) for bioprocess monitoring. This paper highlights how this new technology can simplify media analysis, reduce method development time, and improve real-time data collection for biotherapeutic production.
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Navigating the Intricacies of Lentiviral CGTsScientists are leveraging ddPCR technology to get an accurate read on viral titer and vector copy number.
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Overcoming Operational and Regulatory Challenges in Autologous Cell-Therapy FacilitiesManufacturers must address scale-out challenges of autologous cell therapy for commercial manufacturing.
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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.
