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Predicting Extractables and Leachables from Container StoppersData from migration kinetics studies can be used to develop models that predict levels of leachables and extractables at different temperatures and time points.
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Improved Formulations to Enable Stable Delivery of BiologicsHow dry powder techniques can overcome limitations in biologics development and delivery to broaden routes of administration and global accessibility.
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iMRI-Guided Gene Therapy and Drug Delivery for CNS DisordersLeveraging real-time MRI guidance for intracranial gene therapy administration potentially improves efficacy and outcomes.
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Gibcoᵀᴹ CHO Cell Culture Solutions for BiomanufacturingGain access to essential strategies and solutions for optimizing your CHO cell culture workflow. This exclusive resource offers valuable insights and practical guidance tailored to the challenges of scaling up monoclonal antibody manufacturing with CHO cells.
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Addressing the Training Gap for Single-Use TechnologiesWorkforce training is crucial for biopharmaceutical manufacturing.
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Shining a Light on Lipid Nanoparticle CharacterizationUsing an orthogonal approach to lipid nanoparticle analysis can increase the odds of project success.
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The Marriage of RNA and Mass SpectrometryConsiderable efforts have been made over the years to resolve the key issues of stability and delivery of RNA-based therapeutics.
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Headspace Gas Ingress Methods: The Golden Tool for Container Closure Integrity TestingWebinar Date/Time: Thu, Mar 27, 2025 10:00 AM EDT
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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.
