Authors
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Real Time Continuous Microbiological MonitoringLaser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.
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Leveraging Data Analytics Innovations to Improve Process OutcomesNew data analytics tools help solve complex problems in a biotherapeutic development process.
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Achieving Optimal mAb Titer and Quality Through Cell Culture Media and Supplement OptimizationIn addition to having the optimal cell line and process, it is crucial to have the optimal cell culture medium and feed to maximize performance potential.
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Achieving Optimal mAb Titer and Quality Through Cell Culture Media and Supplement OptimizationIn addition to having the optimal cell line and process, it is crucial to have the optimal cell culture medium and feed to maximize performance potential.
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Achieving Optimal mAb Titer and Quality Through Cell Culture Media and Supplement OptimizationIn addition to having the optimal cell line and process, it is crucial to have the optimal cell culture medium and feed to maximize performance potential.
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Achieving Optimal mAb Titer and Quality Through Cell Culture Media and Supplement OptimizationIn addition to having the optimal cell line and process, it is crucial to have the optimal cell culture medium and feed to maximize performance potential.
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Systematic Approaches to Develop Chemically Defined Cell Culture Feed MediaMaking chemically defined media work.
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Plant-Made Pharmaceuticals—Accelerating Drug Development GloballyPlant transient expression offers a flexible approach in drug development and enables rapid production and scale up of therapeutics.
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Operational Excellence: More Data or Smarter Approach?The authors focus on operational excellence in manufacturing of biotechnology therapeutic products in the QbD paradigm.
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Optimization of Culture Conditions for Expression of Human Interleukin 11To investigate the best culture conditions, the authors used response surface methodology via Box-Behnken design.
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Optimization of Culture Conditions for Expression of Human Interleukin 11To investigate the best culture conditions, the authors used response surface methodology via Box-Behnken design.
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Optimization of Culture Conditions for Expression of Human Interleukin 11To investigate the best culture conditions, the authors used response surface methodology via Box-Behnken design.
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Commercializing High-Concentration mAbsThe development of mAb formulations poses challenges at the manufacturing, stability, analytical, and administration levels.
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Development of a Technique for Quantifying Protein DegradationThis article demonstrates that a modified SDS–PAGE can be easily used as a tool for quantifying the degree of protein degradation.
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Development of a Technique for Quantifying Protein DegradationThis article demonstrates that a modified SDS–PAGE can be easily used as a tool for quantifying the degree of protein degradation.
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Proposing a New Method of Detecting Pinholes in Single-UseThe increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.
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Proposing a New Method of Detecting Pinholes in Single-UseThe increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.
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Development of a Technique for Quantifying Protein DegradationThis article demonstrates that a modified SDS–PAGE can be easily used as a tool for quantifying the degree of protein degradation.
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Proposing a New Method of Detecting Pinholes in Single-UseThe increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.
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Quantifying Host Cell Proteins by LC-MS: Experimental Demonstration and Method Comparison in USP 1132.1Webinar Date/Time: Wed, Feb 26, 2025 11:00 AM EST
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Positive Early Data Seen in COVID-19 Monoclonal Antibody TreatmentThe next-generation monoclonal antibody could potentially be used to prevent and treat active COVID-19 infections, according to its developer, providing a non-vaccine option.
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GSK and CureVac Enter into Licensing AgreementThe companies have restructured their existing collaboration into a licensing agreement that invests in mRNA development.
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Prioritizing Cleaning ValidationAs recent COVID-19 vaccine facility citations make clear, failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.
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Lower Taxes, More Flexibility Crucial to Retaining Pharma EmploymentAs politicians focus on drug cost reduction, biopharmaceutical companies in the US are moving to states with lower taxes, and relocating some facilities that had been offshore.
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Characterizing Critical Quality Attributes in Biopharmaceutical Drug DevelopmentAndrew Bulpin, head of Process Solutions, MilliporeSigma, shares insights on characterizing CQAs in biopharmaceutical development and the different tests that should be carried out when assessing an investigational drug.
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Analysis of PEGylated Protein by Tetra Detection Size Exclusion ChromatographyReliably detecting low amounts of high molecular weight impurities during process development and characterization of biopharmaceutical products.
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Innovations in Prefilled BiologicsPackaging and packaging line innovations are addressing the industry’s growing use of biologics.
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Streamlining Operations in Fill/FinishAdvances in fill/finish for parenteral packaging address demands for efficiency and product safety.
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Considering the Promises of Point-of-Care ManufacturingEmergence of advanced manufacturing technology to ensure quality of biopharmaceutical drugs combined with efforts to identify a regulatory pathway indicate that a distributed manufacturing model is within reach.
