Authors
Latest:
The Effect of Limiting Phosphate Using the HMS174 Cell LineThe HMS174 strain, in the absence or presence of excess phosphate, can metabolize acetate efficiently.
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The Impact of Cell Culture Medium on Cell Line and Process Development Timelines and StrategiesACF medium sped up cell-line development.
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Release and Stability Testing Programs for a Novel Virus-Like Particle VaccineRelease testing involves both standard potency assays and unique assays (particle size, NA activity) developed to ensure the physical, chemical, and biological stability of this type of vaccine.
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Definition of a Security Value Determined by Limulus Amebocyte Lysate Assay Targeting the Recombinant Human Epidermal Growth FactorThe correlation between limulus amebocyte lysate (LAL) assay and rabbit pyrogen test (RPT) targeting recombinant human epidermal growth factor (rhEGF) as active molecule was assessed.
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Polishing Complex Therapeutic ProteinsA new downstream purification platform using a salt-tolerant membrane adsorber.
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Corrective and Preventative Action Programs: A Mechanism of ControlAn effective CAPA plan provides a mechanism for responding to the unexpected.
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Using Metabolic Profiling Technology to Advance Cell Culture DevelopmentThrough metabolomics, the metabolic underpinnings of cellular changes can be rapidly pinpointed, directing process development scientists to key areas for cell culture optimization.
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Developing an Automatically Controlled Feeding Process in an E. coli Fermentation Process for Recombinant Protein ProductionAn exponential feeding strategy coupled with automation doubled protein yields while reducing fermentation time by 25%.
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Freeze Bulk Bags: A Case Study in Disposables ImplementationGenentech's evaluation of single-use technologies for bulk freeze-thaw, storage, and transportation.
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Intensification of a Chromatography PlatformThe authors present a shift toward more integrated purification processes.
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Harvesting the Benefits of LEAN in Biopharmaceutical ManufacturingA step-by-step approach is essential for successful implementation.
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Five Things Every Biotech Company Must Know About BiosimilarsThe new US legislation will forever alter the commercial landscape for biologics.
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Safe Freeze–Thaw of Protein Drug Products: A QbD ApproachApply a DoE strategy to test several formulations in parallel.
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The Proper Use of 47-mm Flat Disc Filters in Filter Sizing StudiesWhy staining is crucial in flow decay studies.
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Integrating CMC Document Preparation into the Development Process for Vaccine INDsVaccine process development is complex, and so are the documents required before clinical trials begin. Technical writers and editors can effectively coordinate the timely authoring, reviewing, and auditing of regulatory documents, minimizing filing delays.
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The Effect of Thermal Cycling on Clamp-Type FittingsHow to control compressive loads on seal materials.
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Analytical Tools for Process and Product CharacterizationSelect the best approach to determine critical quality attributes.
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Biopharmaceutical Facility Cleaning Validation Using the Total Organic Carbon TestCase studies show TOC is effective for cleaning validation.
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Best Practices for Microbial Fermenter Equipment CharacterizationWet testing of microbial fermenters allows for a greater understanding of the equipment's capabilities.
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Sterilizing Filtration of Adjuvanted Vaccines: Ensuring Successful Filter QualificationFilterability and bacterial retention must be verified very early in process development to ensure successful sterilizing filtration validation.
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Advances in Monoclonal Antibody PurificationNew technologies and adaptations of existing technologies can improve platform processes.
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Points to Consider for Human Gene Therapy and Product Quality Control State Food and Drug Administration of ChinaIntroduction - Gene therapy is a medical intervention based on the modification of the genetic material of living cells. Currently, gene therapy is restricted in application to somatic cells.
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Influenza Vaccine Enhancement with Immunomodulating Peptide Thymosin Alpha 1Clinical studies have shown that treatment with thymosin alpha 1 increases response to vaccination.
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Managing Cell Line Instability and Its Impact During Cell Line DevelopmentBy considering stability as part of the cell line selection and cell banking paradigm, we can ensure that instability problems are not observed during clinical or commercial manufacturing.
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Five Things Every Biotech Company Must Know About BiosimilarsThe new US legislation will forever alter the commercial landscape for biologics.
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Pieces of the Inspection Puzzle: The Magnitude and Scope of Behind-the-Scenes Activities During an InspectionA successful outcome to an FDA inspection is the fruit of planning, preparing, and training. Cultivate confident employees who are appropriately coached and clear about their responsibilities.
Latest:
Developing an Automatically Controlled Feeding Process in an E. coli Fermentation Process for Recombinant Protein ProductionAn exponential feeding strategy coupled with automation doubled protein yields while reducing fermentation time by 25%.
