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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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Post-curing on the reduction of cyclosiloxanes (Sept 2022)Watson Marlow Fluid Technologies Solutions (WMFTS), fluid path solutions provider of peristaltic pumps and single-use component, outlines the results of a study which makes comparisons between the semi volatiles extractables profile of post-cured and non post-cured samples of its Pumpsil platinum-cured silicone tubing.
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Perspectives on Process Analytical TechnologyThis article summarizes industry views on PAT in bioprocess-related applications and presents a vision for the biopharmaceutical industry to achieve Industry 4.0.
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A New Route to Pharma GDP Compliance and StandardizationA consensus-based approach to GDP lies at the heart of a new industry-wide program seeking to rationalize, standardize, and harmonize the adherence to pharma transportation norms and regulatory guidelines.
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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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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.
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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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Superior Monoclonality Assurance for a Successful INDUsed by leading pharma companies and CDMOs, the Beacon system offers an integrated end-to-end automated workflow for mammalian cell line development. Clones can be selectively enriched for unique phenotypes and multiple assays can be used to rapidly measure productivity of different antibody molecules.
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Logistical Considerations in mRNA Vaccine DevelopmentDespite its success, clinical and logistical roadblocks to mRNA cancer vaccine development remain.
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Strategy for Derivation and Optimization of a Clonal HEK293 Suspension Cell Line for High Yield AAV ProductionThis commentary summarizes the derivation of clonal HEK293 suspension cell lines, selection of clones for rAAV production, and design of experiments-based optimization strategies for characterization of one clonal isolate for high yield rAAV manufacture. Data shown provides proof of concept for the success of this strategy, its applicability for manufacturing different rAAV serotypes and lays the foundation of further clonal cell line characterization for scale up of production.
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Patentability Considerations for Antibody-Related InventionsStringent patentability requirements present a challenge to obtaining broad-based antibody claims, so companies should develop a strategy based on multiple reinforcing layers of protection.
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Toxicology: Ensuring Drugs are Safe for PeopleAccelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.
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Particle risk mitigation in biomanufacturingWebinar Date/Time: Tue, May 20, 2025 2:00 PM EDT
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Difficulties in Expanding CAR-T Cell Therapy into Solid TumorsThere are various challenges associated with the development of CAR-T therapies for solid tumor cancers.
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Circurna, GATC Health to Use AI for Discovery of Circular RNA TherapeuticsCircular RNA offers enhanced stability and protein expression, making it an intriguing next-generation alternative to mRNA.
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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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Design Quality in Pharmaceutical Design: A Primer for Facility ExecutivesBeing fully versed on the ins and outs of design quality can improve the project design phase life cycle.
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Scientific Due Diligence: The Key to Successful PartnershipsMergers, acquisitions, or partnership agreements in the biopharma sector often flounder due to poor preparation and missteps during scientific due diligence.
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RTU vs. Inline Processing of Vials: Workflow BenefitsSmall batch applications may benefit from pre-sterilized ready-to-use primary packaging components supplied directly to the filling station as an alternative to operating a washing and sterilizing line.
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Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in BiomanufacturingDetermining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.
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Minimizing Contamination During Biopharma R&DThe right approach to biological safety cabinets, and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell-culture contamination.
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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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Translate your idea into product: AI-driven antibody discovery at EvotecOctober 18, 2022, 2pm EDT Evotec recently hosted its Innovation Week webinar series - 5 virtual sessions over 5 days. Session 5 discusses Evotec’s capabilities for supporting all activities across the R&D continuum for biotherapeutics, i.e. Discovery and optimization of novel antibodies for specific disease targets, evaluation of lead antibodies for disease efficacy and safety, alongside process development and manufacturing
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AAV Manufacturing: The benefits of growing serum-free, suspension HEK293 cells in the scale-X™ fixed-bed bioreactorIn this study, HEK293F cells grown in scale-X bioreactor produce >3x higher AAV-2 vector, with 25-52% lower cost than the reference process.
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The COVID-19 Pandemic and Its Positive Impact on RNA Drug DevelopmentThe COVID-19 pandemic helped to showcase RNA molecules and their therapeutic potential. There were also lessons learned in terms of drug delivery, manufacturing, logistics, and storage.
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Proposing a New Method of Detecting Pinholes in Single-UseThe increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.
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Viral Clearance & Viral Safety: Industry Trends & Key EventsWith regulators embracing next-generation sequencing, how will the ICH Q5A(R2) guidelines reshape viral safety strategies for gene and cell therapies?
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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.
