Authors
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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.
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Using Picodroplet Technology to Optimize Bispecific Cell LinesGrowing demand for bispecific antibodies increases the need for automated and miniaturized high throughput screening capabilities.
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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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Viral Safety of Cell Banks: Replacing Animal-Based Assays by One Single GMP Transcriptomic TestWebinar Date/Time: Tue, May 14, 2024 1:00 PM EDT
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Collaborative Efforts Address Key Data Integrity ChallengesMaintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
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AI-Driven Label-Free Quantification of Cell Viability Using Live-Cell AnalysisLive-cell imaging enables acquisition of phase contrast images and provides an ideal platform to study multi-faceted biological paradigms in drug discovery. This is vital to our understanding of human diseases and treatment strategies. The movement of these models towards increasingly complex physiologically relevant ones, including patient-derived cells and induced pluripotent stem cells (iPSCs), has concurrently driven the need for label-free methods that are non-perturbing to deliver deeper biological insights.
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Pharma Services Sector Poised for Continued Growth and ConsolidationThe CRO market will see greater consolidation by both financial buyers looking to consolidate smaller players and larger CRO players wanting to expand into value-added specialty service areas.
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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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eBook: The vital role of QC testingIn this eBook, Symbiosis explores the necessity to offer chemistry, non-sterile microbiology and sterile microbiology testing and the requirements for parenteral preparations.
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Fill/Finish Lessons Learned from COVID-19Can CDMOs apply lessons learned from the COVID-19 pandemic to improve sterile processing?
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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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Commercial Production of Gene Therapies Using Suspension or Adherent Cell LinesThis article will explore the traditional path from the laboratory to the clinic and how the fixed-bed technology provides an alternative solution to meet commercial demands.
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A Unified Approach for Scaling Bioprocess Unit OperationsA unified scale-up approach, as presented here, can be applied to any unit operation.
