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How Artificial Intelligence Impacts the Global Regulatory EnvironmentResponsible data handling, the impact of mishandling data, and how organizations can implement ethical data best practices.
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Challenges When Outsourcing Viral Safety ServicesAssessing biosafety using NGS-based tests requires a continuum of skills in molecular biology, biocomputing, virology, and quality systems.
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1VQ Solutions: Replace Identity (ID) Testing of Incoming Liquid Drug Substance with ID by Visual VerificationA Post Approval Change (PAC) to replace identity (ID) testing of incoming liquid drug substance with ID by visual inspection is considered a low risk provided questioned listed in this example have been answered favorably. In that case the PAC can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.
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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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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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Medical Devices Case StudyOn average, cargo is handled seven times between a manufacturer and a client. As medical equipment moves through the supply chain and hospitals, it can experience mishandling which effects the performance and calibration of the product. With medical devices becoming increasingly sophisticated, they’re more likely to be damaged unless proper precautions are taken. RFID impact indicators alert teams to possible damage due to impact as well as track equipment in use, lowering the loss of due to misplaced or stolen devices.
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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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Subjectivity in Quality Risk ManagementThe authors discuss subjectivity in the ICH Q9 (R1) guidance document.
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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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Facility Design ConsiderationsJohn Bertagnolli, vice-president of Commercial Operations at Selkirk Pharma, discusses considerations when building and scaling up pharmaceutical facilities, including contamination control and aseptic processing challenges.
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Viewpoint: Precompetitive Collaboration Drives Pharma Industry InnovationThe IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.
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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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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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Biologics Quality Control: The Growing Need for Accessible ProteomicsThere is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.
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Specialty Polymers Add Value to Single-use Technologies for Biopharmaceutical ProcessingSpecialty polymers demonstrate the advantages of single-use consumables in biopharmaceutical manufacturing.
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Right the First Time: Bioreactor Scale and Design TranslationThe authors give an overview of scaling approaches and present good scaling practices for the biopharma industry.
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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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Frontrunners in Automated Cell and Gene Therapy ManufacturingInnovative solutions are making personalized cell and gene therapies accessible to all.
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Focusing on Effectiveness for CAPAsCompliance can be greatly improved by concentrating on the basic elements of CAPA investigations, advises Kate Rice, global quality systems manager, Nelson Laboratories, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.
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Purification of Protein by HIC: Mechanistic Modeling for Improved Understanding and Process OptimizationIn this article, a simple chromatographic model is proposed that is capable of predicting the impact of pH and ionic strength on HIC chromatograms.
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Transforming CDMO partnerships through qualityThis whitepaper explores the criteria for defining true quality in a CDMO partnership, including multiple product, process, and relationship variables
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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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Sensitive fluorescent quantitation of DNA with the Quant-iT PicoGreen dsDNA Assay KitHere, we demonstrate how you can reliably measure concentrations as low as 50 pg/mL of double-stranded DNA with our SpectraMax® Multi-Mode Microplate Readers and the Quant-iT Pico Green assay.
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The First Optimized Self-Replicating RNA (srRNA) TechnologyThis inaugural edition of the Pivotal Paper series features leading vaccine experts discussing a groundbreaking study on next-generation self-replicating RNA (srRNA) vaccine technology. The panel explores the study’s key findings, highlighting srRNA’s potential for lower-dose, single-dose vaccines with enhanced immune response, expanding the applications beyond infectious diseases.
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Optimizing Adaptive Trials: The Role of On-Demand Manufacturing and Derisking in Accelerating Early Clinical Trial SuccessWebinar Date/Time: Wednesday, April 2, 2025 11:00 AM EST
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Automated Inspection of Pre-filled Syringes and Biologics During Fill/FinishShifts in pharmaceutical packaging have spurred tremendous growth in the pre-filled syringe fill/finish industry.
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Overcoming Engineering Challenges to Enable Commercial Scale mRNA Vaccine ManufacturingThis article provides an overview of solutions to address key challenges facing vaccine developers or CDMOs wishing to build their own commercial-scale mRNA production facilities.
