Authors
Latest:
QbD: A Roadmap to AdoptionThe nimbleness of biotechs makes them well suited to implementing QbD. Here's how to get started.
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High-Cell-Density Culture to Produce Plasmid DNA for Gene Therapy in E. coliHow to produce Plasmid DNA in a high-cell-density culture.
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Meningitis Vaccine Manufacturing: Fermentation Harvest Procedures Affect PurificationCareful analysis of an unusual precipitate identifies defects.
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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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Tangential Flow Filtration for the Recovery of Acellular Pertussis Vaccine ComponentsMembrane-based TFF technology can ease scale-up and provide a higher recovery percentage compared to conventional purification methods.
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Mathematical Programming for the Design and Analysis of a Biologics Facility-Part 2An algorithmic approach to fine tune facility design and predict capacity.
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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How to Make Improvement Programs WorkA true visionary leadership is required to drive the progress of operational excellence programs in biopharmaceutical organizations
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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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Quality by Design and Compliance ReadinessHow will implementing Quality by Design strategies affect your compliance status?
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Development of a Novel Rolling-Tube Cell Culture Platform and Demonstration of System FeasibilityRolling-tube system balances scale-up accuracy and thoroughput.
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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New Approaches to Improved Vaccine Manufacturing in Embryonated EggsRecombinant vector technologies can improve the yield and lower the cost of egg-based influenza vaccine production.
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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Rapid Assessment of Molecular Similarity between a Candidate Biosimilar and an Innovator Monoclonal Antibody Using Complementary LC–MS MethodsIntact protein LC–MS detected a mass variance of 62 Da and peptide mapping located a difference of two amino acids.
Latest:
High-Cell-Density Culture to Produce Plasmid DNA for Gene Therapy in E. coliHow to produce Plasmid DNA in a high-cell-density culture.
Latest:
Tangential Flow Filtration for the Recovery of Acellular Pertussis Vaccine ComponentsMembrane-based TFF technology can ease scale-up and provide a higher recovery percentage compared to conventional purification methods.
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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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Modular Construction: Innovation, Flexibility, and Adaptibility by DesignIdentifying issues in the factory that traditionally arise in the field minimized onsite equipment rework and subsequent qualification work.
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Characterization of Aluminum Hydroxide Gel and Oil-in-Water Emulsion Formulations Containing CpG ODNsAdjuvant activity can be greatly improved by appropriate formulation of cytosine-phosphorothioate-guanine oligodeoxynucleotides (CpG ODNs).
Latest:
Development of a Novel Rolling-Tube Cell Culture Platform and Demonstration of System FeasibilityRolling-tube system balances scale-up accuracy and thoroughput.
Latest:
Rapid Assessment of Molecular Similarity between a Candidate Biosimilar and an Innovator Monoclonal Antibody Using Complementary LC–MS MethodsIntact protein LC–MS detected a mass variance of 62 Da and peptide mapping located a difference of two amino acids.
Latest:
Fermentation Process Technology Transfer for Production of a Recombinant Vaccine ComponentThe authors describe challenges faced in transfer and scale-up of a fermentation process.
Latest:
Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
