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Why Automation with the Correct Liquid Handler is Integral to Improved NGS OutcomesNGS abbreviates drug discovery timelines.
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Preparing for a New Wave of mRNA TechnologiesTo prepare for emerging mRNA technologies, it is necessary to adapt fill/finish and cold chain capabilities.
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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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Assessing Manufacturing Process RobustnessA structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
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Ensuring Cell Line Stability for Protein TherapeuticsStable cell line development can benefit from applying integrated analytical technologies.
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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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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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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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How Modularization and Digital Delivery are Transforming Pharma ManufacturingModular and replication strategies are being utilized to meet growing demand for CDMO facilities.
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Current Trends in Host Cell Protein Detection for Biologics ManufacturingIn this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.
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Innovations in Downstream ProcessingInnovations in downstream processing accelerate development, enhance efficiency, and promote sustainability.
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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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Vi-CELL BLU Cell Viability Analyzer by Beckman Coulter Life SciencesThe Vi-CELL BLU automates the widely accepted trypan blue dye exclusion method for cell viability that has historically been performed with a light microscope, pipette, and a hemacytometer.
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Leveraging Artificial Intelligence and Human Know-How to Accelerate Drug DiscoveryThrough the integration of human expertise, artificial intelligence, and automation robotics, bio/pharma companies can more efficiently target drug discovery efforts with bigger payoff.
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Temperature and Relative Humidity Control to Reduce Bioburden in a Closed Cell Processing and Production System without DisinfectantsControlling certain atmospheric conditions in a closed NGI processing chamber can reduce bioburden without disinfectants.
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Optimizing Cell Line Development for Next Generation BiologicsImproving the flexibility of cell line development through utilization of platform approaches and suitable partnerships can reduce potential bottlenecks in the development pathway of novel biologics.
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Brazilian Regulation of Biosimilar Products: What Is Important to KnowThis article introduces the requirements for a biosimilar license in Brazil and addresses questions about their quality, safety, and efficacy.
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Biological Decontamination of a Vaccine Production FacilityAn industrial biotechnology company in Denmark required more rigorous control measures to ensure a high level of bio-decontamination in its facility. An automated hydrogen peroxide vapor service from Bioquell was selected.
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Revolutionizing Biomanufacturing: The Digitalization AdvantageDigital transformation allows for smarter and connected biomanufacturing operations.
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It’s Time for CDMOs to Embrace the CRISPR AdvantageCDMOs are actively exploring and leveraging both new and existing technologies to streamline the cell-line development process at every step.
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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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Mathematical Modeling of Cell-based Potency Data for mAb BiotherapeuticsA novel mathematical approach for fitting concentration-response curves is proposed that offers a more accurate estimation of potency data.
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A Systematic Evaluation of Risks and Mitigation Strategies for Convalescent Plasma Therapy for COVID-19A task force details its findings of the risks associated with using convalescent plasma using failure mode and effects analysis
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Designing Flexible Fill/Finish FacilitiesScenario modeling informs planning for current and future manufacturing needs.
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Advanced Therapies Week 2025: Jan. 20–23, 2025This event offers knowledge sharing, relationship building, and deal-making for biotech and pharmaceutical companies to advance commercialization of advanced therapies.
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Utilizing Image Analysis Algorithm for Therapeutic mAb Aggregate AnalysisTherapeutic protein aggregates can be characterized using image analysis algorithms coupled with microscopy techniques.
