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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.
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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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Fully-Connected Continuous Manufacturing™ as the Key to Cost Efficiency and Scalability in BiotechInnovative Fully-Connected Continuous Manufacturing™ technology and advanced facilities are revolutionizing biomanufacturing and driving cost efficiency, especially in monoclonal antibody production.
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The Future of Media Hydration: Balanced Media in Automated Single-use PlatformsWebinar Date/Time: Tue, Mar 4, 2025 11:00 AM EST
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Innovations and Trends in Aseptic Manufacturing ProcessesThe steady rise in popularity of gene therapies and other biologics is the underlying reason for the growing importance of aseptic manufacturing processes in the biopharmaceutical industry.
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CPHI Frankfurt: Selecting the Right Outsourcing Strategy and PartnerSponsors should explore key considerations ahead of choosing a new outsourcing partner.
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Evaluating CMO/CDMO End-to-End Expertise: The Importance of Standardizing Cold ChainConversations with CMOs/CDMOs about capabilities and how they work to reduce complexities in the supply chain should focus on cost efficiency, temperature excursions, and sustainability.
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Purification Strategies to Process 5 g/L Titers of Monoclonal AntibodiesAltering the order of operations, using new resins, and increasing dynamic binding capacity can obviate the need for major facilty changes.
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Simulations Improve Production CapacityAs biotechnology organizations have successfully launched new products, the challenges of producing adequate quantities have grown. Many companies are now dealing with multiproduct manufacturing facilities and pushing the limits of their capabilities. One result of this complexity is a loss of production capacity due to inefficiencies.
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Funding Biodefense Vaccine DevelopmentBiodefense start-up companies have an abundance of options when seeking funding.
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The Development and Application of a Monoclonal Antibody Purification PlatformA purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.
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Upcoming Technologies to Facilitate More Efficient Biologics ManufacturingChoosing the right tools to enhance the process.
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Opalescence of an IgG1 Monoclonal Antibody Formulation is Mediated by Ionic Strength and ExcipientsCan increase in ionic strength result in higher viscosity?
