Authors
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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.
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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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Introducing the BIOne 10L Single-Use BioreactorThe BIOne 10L SUB is highly innovative with expanded processing capabilities, ideal for scale-down modeling, material generation, and process optimization.
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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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Reimagining Affordable BiosimilarsAdvances in preclinical development play a crucial role in reducing cost for developing biosimilars.
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Transforming Process Development with AI: Success Stories from mAbs to Emerging ModalitiesWebinar Date/Time: Thu, Thu, Apr 18, 2024 11:00 AM EDT
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Addressing the Training Gap for Single-Use TechnologiesWorkforce training is crucial for biopharmaceutical manufacturing.
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Scaling Manufacturing Processes Using Single-Use TechnologiesAlthough new single-use technologies offer the flexibility needed to overcome several challenges in ATMP production, there are many considerations and hurdles manufacturers must be aware of when scaling.
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New Developments in Plasma ProteomicsA single protein or gene expression product can exist in multiple proteoforms due to alternative splicing, point mutations, post translational modifications and endogenous proteolysis.
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Improving Vector Yield at Scale: A Fresh Approach to Cell Lysis Quality AssessmentOptimizing the harvest of viral particles is important for the yield and purity of the final product.
