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Life Sciences and Socially Responsible InvestingMore than $1 out of every $9 under professional management in the United States is involved in socially responsible investing.
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The Benefits of Combining UHPLC-UV and MS for Peptide Impurity ProfilingDetermining a peptide’s purity is challenging because impurities are often structurally similar to each other and the API and can be present at very low concentrations. New approaches offer a solution.
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From the Editor in Chief: New BeginningsBioPharm International is about to embark on another new beginning. You'll remember the magazine (along with the primers, supplements and media kit) had a drastic new beginning in February of 2004 when we launched the major redesign. There were other new beginnings in the past two and one-half years, like five new columns (StreetTalk, Operations Excellence, BioPartnerships, Compliance Briefing and Final Word.) You'll even see a sixth column about legal issues in 2006.
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Back to the Pharma FutureRecognize that the drug drought is the "disease" underlying many of pharma's troubling symptoms, and the cure becomes apparent.
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Understanding Leaching from Stoppers into Lyophilized DrugsMost extractable and leachable (E&L) studies are based on liquid formulations. This article examines options for E&L studies to evaluate leaching from primary packaging into lyophilized drugs.
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Operations Excellence: BioPharma Operations ExcellenceFormal process and operation improvement activities are being employed in almost every biopharmaceutical manufacturing company, according to a recent survey conducted by Tefen Ltd and Millipore Corporation. The industry-wide survey was conducted to assess current biopharmaceutical operations excellence (OpEx) trends and needs, as well as OpEx perceptions and expectations related to industry suppliers.
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Emerging Therapies Test Existing Bioanalytical MethodsDrug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.
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Emerging Therapies Test Existing Bioanalytical MethodsDrug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.
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Emerging Therapies Test Existing Bioanalytical MethodsDrug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.
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Emerging Therapies Test Existing Bioanalytical MethodsDrug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.
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Validation of ICON™ Automated Cell Counting and Viability Assay (August 2022)This benchmarking study compares the Advanced Instruments Solentim ICON™ viability assay to the performance of a commercially available cell counter. The results demonstrate lower variation, increased precision, and time savings.
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Successfully Moving Regulated Data to the CloudIn light of recent FDA guidance on data integrity, the challenges and benefits of using the public cloud to deploy and use data management software are discussed.
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Process Validation Sets the Stage for Ongoing Manufacturing QualityA properly designed validation program will detect variation and ensure control based on process risk.
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CMOs Leading the Way on Single-Use Systems AdoptionSingle-use systems can be a cost savings for CMOs, and these savings can be passed on to clients and, ultimately, to patients.
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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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Breathing Life into Biopharma: Oxygen Sensors for SuccessAs the global demand for cell culture continues to grow year after year, experts are developing new tools to ensure the environment for growing cells can be improved through continuous monitoring and control.
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Unlocking Protein Therapeutics Potential: Aura PTx for Advanced Stability StudiesWebinar Date/Time: Wed, Mar 19, 2025 1:00 PM EDT
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Are You Ready For USP ?Download this application note to learn about hazardous drugs basics - listing through storage, engineering controls and training programs, and why you shouldn’t wait, regardless of initial enforcement for your facility.
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High-Throughput Multi-Product Liquid Chromatography for Characterization of Monoclonal AntibodiesThese new analytical methods can reduce analysis and product development time.
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Leveraging Computational Models of Glycosylation for Biopharma QAClose collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.
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Cleaning Chromatography Resin Residues from SurfacesLaboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.
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The Role of Analytical Science in the Debate over BiosimilarsBoth innovator and generics companies are using analytics to support comparability arguments.
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Next Generation Peptide Mapping with Ultra Performance Liquid ChromatographyUltra performance liquid chromatography (UPLC) is a new category of liquid chromatography that researchers are using to increase resolution, speed, and sensitivity in a variety of applications. These benefits result from packing columns with 1.7 ?m particles and using instruments that are optimized for such columns.
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CMC Due Diligence for Accelerated Biologic Drug Development and ManufacturingThe growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.
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Points to Consider for Continuous Downstream BioprocessingIt is critical to evaluate specific considerations, from design to application, for the benefit of downstream bioprocessing and manufacturing.
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Complex and Customized: Manufacturing New Molecular FormatsIncreasingly complex monoclonal antibody molecules will require the right “tool box” for scaling up manufacturing.
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CMC Due Diligence for Accelerated Biologic Drug Development and ManufacturingThe growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.
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The State of the Used-Equipment MarketToday, there is a global adoption of buying and selling used equipment. This article reviews what organizations should look for when considering the purchase of used equipment.
