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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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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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Difficulties in Expanding CAR-T Cell Therapy into Solid TumorsThere are various challenges associated with the development of CAR-T therapies for solid tumor cancers.
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Powering Clinical Operations With Knowledge Graphs and LLMs With Merck KGaA, Darmstadt, GermanyWebinar Date/Time: Thu, Mar 13, 2025 11:00 AM EDT
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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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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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Streamlining Method Transfer Across Global SitesThis article discusses standardized analytical method-transfer kits that have been developed to streamline method transfer and site certification at Eli Lilly. Use of these kits has been proven to improve overall efficiency and to reduce cost and time requirements for method transfer.
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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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Collaborative Efforts Address Key Data Integrity ChallengesMaintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
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A Unified Approach for Scaling Bioprocess Unit OperationsA unified scale-up approach, as presented here, can be applied to any unit operation.
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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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Navigating Challenges in Cell Therapy Potency AssaysDeveloping cell-based potency assays for cell therapies requires meticulous coordination.
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Introducing a New Concept for Value-Driven Acceleration in Biopharma DevelopmentUsing a minimum valuable product and process approach would make it is possible to discipline and structure the development of biopharmaceuticals in the fastest way possible.
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Advances in Real-Time Supply Chain Operation Technology Can Address Drug Product Security ChallengesTechnological developments in real-time supply chain operations provide biologics manufacturers with capabilities that go beyond supply chain visibility to tangibly address security and quality challenges.
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DSCSA’s Next Big HurdleInteroperability by 2023 depends on data standardization and systems compatibility between trading partners.
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Enabling the Virtual Human Through Physiologically-based Pharmacokinetic ModelingBasic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed.
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Collaborative Efforts Address Key Data Integrity ChallengesMaintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
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Machine Learning and Data Analysis for Optimal Productivity of Pharmaceutical Water SystemsLeveraging smart technology and SMEs for significant operational and financial benefits.
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Innovative Start-Ups at CPHI BarcelonaThe Start-Up Market at CPHI Barcelona brings together 27 start-ups, innovators, and small enterprises from across the pharma landscape.
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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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A Harmonized Approach to Performing a Risk-Based Audit Trail ReviewThe IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
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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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Eurofins PSS Insourcing Solutions®Eurofins PSS Insourcing Solutions® hires and manages our employees to support testing at your site.
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Cleanroom Cleaning: Proper Methodology and Determining EfficacyEffective cleaning and disinfection along with contamination controls are imperative when operating and utilizing a cleanroom.
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Streamlining Method Transfer Across Global SitesThis article discusses standardized analytical method-transfer kits that have been developed to streamline method transfer and site certification at Eli Lilly. Use of these kits has been proven to improve overall efficiency and to reduce cost and time requirements for method transfer.
Latest:
Collaborative Efforts Address Key Data Integrity ChallengesMaintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
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The Lighthouse Effect: Using Technology to Improve Life Sciences ManufacturingLighthouse manufacturing techniques utilize technology and automation to streamline production.
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When Is It Appropriate to Outsource Bioanalysis Work to a CRO?When considering whether to outsource work to a CRO, there are a number of factors to assess, including the type of work that may be outsourced, regulatory considerations, and needs for the study.
