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Latest:
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.
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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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Developing a MAb Aggregate Removal Step by High Throughput Process DevelopmentHTPD allows rapid screening of chromatographic parameters.
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A Study of Leachables for Biopharmaceutical Formulations Stored in Rubber-Stoppered Glass VialsA systematic approach facilitates formulation component selection.
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Development of an Alternative Monoclonal Antibody Polishing StepMAb polishing using salt tolerant interaction membrane chromatography.
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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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Partial Replacement of Chemically Defined Media with Plant-Derived Protein HydrolysatesPlant-derived hydrolysates can be used as valuable and practical tools to improve cell culture performance.
Latest:
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.
Latest:
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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Cost of Goods Modeling and Quality by Design for Developing Cost-Effective ProcessesCombine cost analyses with QbD to improve operations and lower costs.
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Optimizing Vaccine Adjuvant FiltrationThe viscosity of oily emulsions can reduce filter capacity and bacterial retention.
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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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The Impact of Cell Culture Medium on Cell Line and Process Development Timelines and StrategiesACF medium sped up cell-line development.
Latest:
Biopharmaceutical Facility Cleaning Validation Using the Total Organic Carbon TestCase studies show TOC is effective for cleaning validation.
Latest:
Advances in Monoclonal Antibody PurificationNew technologies and adaptations of existing technologies can improve platform processes.
Latest:
The Impact of Cell Culture Medium on Cell Line and Process Development Timelines and StrategiesACF medium sped up cell-line development.
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%.
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%.
Latest:
Balancing Media Development with Patient SafetyThe quest for increased productivity and better process control combined with patient safety has encouraged biopharmaceutical companies to use chemically defined media for cell culture.
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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.
Latest:
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.
