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Designing a Control Strategy for Facilities with Single-Use SystemsEarly control architecture decisions can impact a facility’s long-term growth, flexibility, and efficiency.
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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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Overcoming oncolytic virus therapy production challenges through collaborationDiscover how ReciBioPharm’s strategic approach helped to support the rapid delivery of an innovative oncolytic adenovirus therapy for advanced cancer to clinic.
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Biopharmaceutical Excipients: Everything You Need to KnowThis article represents a comprehensive exploration about biopharmaceutical excipients, exploring their multifaceted classification, active role in drug formulation processes, inherent challenges, and upcoming advancements poised to revolutionize the drug formulation and its efficacy for patient welfare.
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EASY: a Disruptive mAb Purification Process to Reduce Cost of GoodsThe development of an innovative purification process simplifies downstream processing for biologics.
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Designing Flexible Fill/Finish FacilitiesScenario modeling informs planning for current and future manufacturing needs.
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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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Digitalization: The Route to Biopharma 4.0The implementation of Industry 4.0 is projected to save time and cost for designing an optimal manufacturing process.
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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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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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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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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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Taking a Closer Look at Lipid Nanoparticle CharacterizationAn orthogonal approach to lipid nanoparticle analysis is recommended to optimize drug development success.
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Technology Forum Series: Strategies to Prevent Drug Shortages and Resolve Capacity Challenges.***Session 1: Thursday, April 22, 2021, 10am EDT, Session 2: Thursday, April 22, 2021, 11am EDT, Session 3: Thursday, April 22, 2021, 1pm EDT*** A drug’s journey from development to manufacturing to patients is paved with roadblocks and potholes; many threats can derail bio/pharmaceutical processes. Potential solutions to such pitfalls have been discussed for years; however, few manufacturers have embraced technology and process advances to proactively ensure drug supply chain continuity.
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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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Qualifying AI Algorithms in Pharmaceutical ManufacturingQualified algorithms enable validation of machine learning models that can be used for process optimization.
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Real-Time Post-Apheresis Documentation Decreases ErrorsDocument integrity is critical in the provision of raw materials for cell and gene therapy manufacturing.
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Modernization of India’s Pharma Manufacturing Industry: “Leader” or “Laggard”Guest contributor B.S. Sathya Durga discusses the importance of modernizing India's pharmaceutical manufacturing industry.
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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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Addressing manufacturing at scale for ATMP’sAddressing manufacturing at scale for ATMP’s. Reducing costs through reducing batch failures and shrinking footprints, and targeting more focused critical quality attributes for potency but also patient efficacy. Reducing regulatory uncertainty in an uncertain environment to increase patient access to life saving cures.
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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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Guidance on Quality Culture StandardsMatt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
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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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The Evolving Cost-Benefit Landscape of Biosimilar Drug DevelopmentWith more than 100 next-generation biologics set to lose patent exclusivity in the next 15 years, there is widespread agreement that developing biosimilars for these therapies will benefit society as a whole.
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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.
