Authors
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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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Elements for a Sustainable Environmental Monitoring ProgramAsking why things are done a certain way will help make an accurate assessment of an organization’s EM program, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, and Zachary S. Anderson, global market segment lead—Sterility Assurance, Nelson Laboratories.
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Therapeutic Delivery for Brain-Related ConditionsAt BIO 2024 in San Diego, John Dunlop, PhD, chief scientific officer at Aliada Therapeutics, sat down for an interview with BioPharm International to discuss the firm’s MODEL platform and its potential impact on therapeutic delivery for brain-related conditions.
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Subjectivity in Quality Risk ManagementThe authors discuss subjectivity in the ICH Q9 (R1) guidance document.
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Development Strategies for Cell and Gene Therapy MethodsThe increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.
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Development Strategies for Cell and Gene Therapy MethodsThe increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.
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Connected Software Solutions Streamline Biopharma MS WorkflowsThe integration of modern software tools can make the acquisition and analysis of MS data more efficient, accurate, and compliant.
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Biosimilars Drug Development: Advances in Technologies from Molecule Design to Clinical TrialsThe authors have reviewed applications of novel technologies in the major stages of biosimilars development: process development, pharmacology, toxicology, and clinical trials, with an emphasis on recent regulatory requirements.
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How a Lack of Critical Thinking is Hindering Regulatory ComplianceWhy critical thinking must be applied before technology to ensure regulatory compliance.
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Strong Quality Culture: A How-To for Busy ManagersBuilding employee participation and forming good habits contribute to a company-wide quality culture that pays off.
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2020 Bio/Pharma Virtual Congress*** Live: Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT *** 2020 Bio/Pharma Virtual Congress: Join Pharmaceutical Technology® and BioPharm International® for this online event that will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry. ***On demand available after final airing until 11/11/2021***
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Using Modeling to Improve Data Analytics for Upstream Bioprocessing WorkflowsRecent trends in data analytics highlight the use of modeling techniques to improve process control and monitoring in biopharmaceutical production.
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Bioreactor, PAT and Lucullus Control SynergiesThe Lucullus process information management system facilitates bioprocess development and optimization by centralizing data management and control of multiple BR1000 bioreactor systems that each employ dynamic PAT-driven glucose feeding
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Purification of Antibodies Using Novel Convecdiff Membranes Part 2: Robust Performance at Comparable Product QualityIn part 2 of this article, results from the testing of a next generation convecdiff membrane are discussed.
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Challenges in Bulk Drug Substance ManagementHow can liquid drug substances be safety stored and transported between downstream and fill/finish processes?
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Getting to the Root of the Matter for Bio/Pharma Quality IssuesBio/pharma can learn ways to prevent recurring events and ineffective CAPA from the nuclear power sector.
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Valuing Specialized Experience in ADC DevelopmentBringing promising ADC candidates to market faster hinges on the biopharma industry investing in linker design capabilities.
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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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Stability Studies: An Essential Step for Quality Management in Drug DevelopmentSufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it.
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Virus-like Particles as Therapeutic Moieties of the FutureAnalytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
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Automation of MS Analytics for Characterization of BiotherapeuticsMarch 17th 2022 at 10am EST | 9am CST | 3pm GMT | 4pm CET • Automating and Streamlining MS-Based Developability Assessment of Biotherapeutics• Automating MS-Based Biotherapeutic Characterization Workflows for Developability
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The Ins and Outs of Syringe InspectionA best practices approach to pharma’s most challenging-to-inspect container.
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Accelerating the Development of mRNA TherapeuticsManufacturing and processing challenges surrounding mRNA can be overcome in order to realize the true potential of a technology 30 years in the making.
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Current Challenges with Cell Culture Scale-up for Biologics ProductionBioreactor technology advances can offer seamless manufacturing scale-up and can reduce the timeline and cost of biologics production.
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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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Emergence of India as a Global Manufacturing Hub for BiosimilarsThe biopharmaceutical landscape of India is transforming in terms of regulatory policies, product development, and affordability.
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Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in BiomanufacturingDetermining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.
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Preparing for the Future: Expanding Capacity and Facilitating Multi-modalitiesCDMOs need to consistently demonstrate agility as demand increases for newly developed therapeutic modalities.
