Authors
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QMS Buyer's GuideQuality management is inherently complex. That’s why you need QMS software that’s suited to your company’s unique needs. This comprehensive resource shows you the key quality management software features to look for and ways modern tools can give you an edge today while paving the way for success tomorrow. Wherever you are on your buyer journey, the foundation provided in this guide will help you make the right choice.
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Selecting the Right CMC Strategy for BiologicsSmaller biopharma companies must do due diligence with their CMC strategy for BLA filings.
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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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Data Integrity Considerations for Vendor-Generated Data Associated with Analytical TestingSponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.
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Tackling Cybersecurity Challenges in Legacy SystemsOngoing and emerging cyber-risks to legacy operational technology systems in bio/pharmaceutical manufacturing must be addressed.
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Formulating Autologous Therapies for CancerAutologous tumor cells engineered for immune system stimulation can target unique metabolic, genomic, and phenotypic characteristics of cancer cells.
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Reimagining Progress: Partnering for the Future of Bio/PharmaThe bio/pharma industry is evolving with intention, intelligence, and a growing sense of shared purpose.
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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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Leveraging Data for Predictive & Real-time Bioprocess Performance ImprovementsThu, Sep 8, 2022 11am EST | 8am PST | 4pm BST | 5pm CEST Digitalization & leveraging real-time data are key for biopharma process improvement. Insilico models and soft-sensors boost biopharma performance to unprecedented levels.
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Scalable seed train intensification and automation for adherent cell culturesThis application note explores the feasibility of utilizing the scale-X carbo bioreactor as a solution for seed train intensification.
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Comparative Deterministic Cold Storage Headspace Analysis–Multi-sourced Injectable Container Closure SystemsThis study evaluates the best-in-class elastomer compounds, formulations, and coatings, affixed with aluminum seals and press-on caps to Type I borosilicate tubular glass vials conforming to the International Organization for Standardization (ISO 8362) injection containers requirements.
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Advancing Enzyme AnalysisFully automated enzyme analysis can ease a persistent bottleneck in biocatalyst development for bio/pharmaceutical applications.
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Industry 1VQ Solutions: Change of Lot or Extension of Shelf-life of Reference StandardChange of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.
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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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Public Trust in Medicine Quality as Public Health Challenges EmergePublic health challenges have highlighted the need for agility in maintaining the quality of medicines.
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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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Strategic Changes to a Legacy Cleaning Approach Result in a More Sustainable ProcessIn this article, the authors explored the elimination of a water rinse and blow down following the caustic wash step, examining potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing this change.
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The Facility of the FutureCritical considerations for deploying smart, fast, and flexible Life Sciences facilities
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Evolution of Analytical Procedure Validation Concepts: Part IIThis article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.
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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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Do Modeling and Simulation Tools Really Benefit the Biosimilar Industry?The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.
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The Future of Manufacturing, Safety, and CollaborationThe panel highlights the need for continued research, collaboration between stakeholders, and a strategic approach to leveraging mRNA's capabilities to address unmet clinical needs.
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Tools and Technologies for Robust Method Lifecycle Management in Liquid ChromatographyAdvanced LC technologies can streamline the review process for LC equipment maintenance.
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Points to Consider for Knowledge Management AccelerationQuality quartets support an integrated and stable combination of commissioning and qualification and quality risk management processes.
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Converting Injectable Therapies to Combination Drug-Device ProductsThe author describes how to seize market opportunities while navigating the requirements of both drug therapies and delivery devices.
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Selecting a CMO Partner for Sterile Injectable ManufacturingVetting contract fill finish manufacturers is about more than their capacity. Jubilant HollisterStier advises on what to look for in a sterile fill finish partner.
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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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A Step Closer to Closure in BioprocessingAs biopharma anticipates the “Facility of the Future,” a definition of what closed processing is, and quantification of its value, can be helpful information.
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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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ACS-Grade Reagents’ Database LaunchedThe complete online database of ACS Reagent Chemicals is now available.
