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NIST Fluorescence-Based Measurement ServicesFluorescence has long been used to detect biological targets. As these measurements are becoming more and more quantitative, standards are needed to ensure accuracy and reproducibility.
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NIST Fluorescence-Based Measurement ServicesFluorescence has long been used to detect biological targets. As these measurements are becoming more and more quantitative, standards are needed to ensure accuracy and reproducibility.
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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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Biopharmaceutical Manufacturing Using Blow–Fill–Seal TechnologyThe authors give special consideration factors affecting blow–fill–seal technology.
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Modeling the Degradation of mAb TherapeuticsKinetic models can be used to study aggregation and fragmentation to help ensure stability.
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Efficacy of a Simple Static Cleaning Procedure for SPTFFA key technology that can help achieve a continuous production flow is single-pass tangential flow filtration.
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Efficacy of a Simple Static Cleaning Procedure for SPTFFA key technology that can help achieve a continuous production flow is single-pass tangential flow filtration.
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Efficacy of a Simple Static Cleaning Procedure for SPTFFA key technology that can help achieve a continuous production flow is single-pass tangential flow filtration.
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Advanced Analytical Approaches for Accelerated Development of Gene Therapy ProductsDownload the White Paper and learn how detailed characterization can guide successful development of gene therapy products.
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Bioengineered Protein A Polymer Beads for High-Affinity Antibody PurificationThe authors discuss an alternative to traditional Protein A resins.
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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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Biophysical and Aggregate Characterization for the Development of BiologicsThis eBook explores how advanced particle analysis technologies are revolutionizing biologic drug development. It highlights the importance of accurately identifying and characterizing subvisible particles to ensure drug safety, stability, and regulatory compliance. Techniques like Backgrounded Membrane Imaging (BMI) and Fluorescence Membrane Microscopy (FMM) are often used for their capabilities in detecting protein aggregates and degraded excipients such as polysorbates. Case studies and experimental results demonstrate how these tools provide high-throughput, low-volume analysis that enhances decision-making in formulation screening and manufacturing.
