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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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Tactics and Strategies for Designing an Ideal Lentiviral Vector PlatformThere is growing pressure for robust and economically scalable viral-vector manufacturing technologies.
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Tactics and Strategies for Designing an Ideal Lentiviral Vector PlatformThere is growing pressure for robust and economically scalable viral-vector manufacturing technologies.
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Best Practice Tech Transfer Methods for CGTsA look at using best practice tech transfer methods for CGTs to increase process and analytics robustness while being scalable.
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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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One-Step Cell Clarification and Sterile FiltrationThe paper reviews a new 24-well filter plate that clarifies and sterile filters high-density cells in one step in minutes. Its depth filter efficiently clarifies cells while a dual-layer membrane provides high-performance sterile filtration
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The Future of Manufacturing, Safety, and CollaborationThe panel highlights the need for continued research, collaboration between stakeholders, and a strategic approach to leveraging mRNA's capabilities to address unmet clinical needs.
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Extractables Protocol for Single-Use Disc-Stack SeparatorsThis case study describes how the risk assessment of the first-to-market single-use disc-stack centrifuge was conducted.
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Protecting Both Intellectual Property and ProgressThe Hatch Waxman safe harbor provision exempts otherwise infringing uses of patented materials if they are in furtherance of a regulatory submission, but the use of patented research tools may fall outside its protection.
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Small-Scale Syringe and Vial-Filling Capability for Development of Robust Filling Processes, Smooth Tech Transfers, and to Resolve Manufacturing Issues: Summary of Key LearningsUse of a small-scale filler can result in increased filling efficiency.
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Strategic Changes to a Legacy Cleaning Approach Result in a More Sustainable ProcessIn this article, the authors explored the elimination of a water rinse and blow down following the caustic wash step, examining potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing this change.
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G-CON Clean Solutions Cleanroom ProductsNow supplying cleanroom doors, panels and accessories for all cleanroom applications.
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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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Conformational and Colloidal Stability Studies to Predict the Best Biopharmaceutical FormulationEstablishing analytical workflows for complex biopharmaceutical molecules can help predict their risk of degradation.
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Seasonal Vaccine Manufacturing v2The seasonal influenza vaccine market is projected to reach more than $4 Billion USD by the end of 2022. It is a safe assumption that as demand for seasonal influenza vaccines increases, so too with the demand for contract manufacturing organizations (CMOs) to support.
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Temperature Control for Chemical Research and Production (Nov 2022)Precise temperature control has a significant influence on performance and quality in chemical process engineering. The Unistat range of temperature control systems ensure accurate temperatures and stable process conditions in research laboratories, pilot plants and kilolabs worldwide.
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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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Building Velocity into Fill/Finish Timelines: Your Guide to Quality and Regulatory Success in the CDMO SpacePartnering with a CDMO with collective insights and capabilities to support the development and manufacture of an innovative biotherapeutic program is an essential first step to providing better care to patients.
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Nova Medical's BioProfile FLEX2 Cell Culture AnalyzerFLEX2—16-test cell culture analyzer with chemistries, gases, cdv, and osmolality; automated sampling; and refrigerated retains.
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Considering a Coating Technology as an Alternative to Silicone OilA coating technology for a staked needle prefillable syringe reduces the potential risks associated with silicone oil as a lubricant.
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How Pure is Pure? Understanding Reagent Purity GradesAs interest in cell and gene therapies continues to grow, the need for safe and consistent reagents to support research, development, and manufacture efforts also increases.
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Viral Clearance Studies: Challenges and BeyondThe design of viral clearance studies must keep pace with the quickly evolving biologic drugs industry.
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Material Management and the Impact on Extractables and LeachablesBy understanding potential material change, the impact on patient safety can be understood and mitigated.
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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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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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Growth in Cell and Gene Therapy MarketBiopharma focuses on streamlining biomanufacturing and supply chain issues to drive uptake of cell and gene therapies.
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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.
