Authors
Latest:
Analytical Tools for Process and Product CharacterizationSelect the best approach to determine critical quality attributes.
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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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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.
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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Effective Auditing of CMOsIt is important that all stages of the audit be given an equal measure of attention.
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Scale up of Fed-Batch Culture to Produce Plasmid DNA in Escherichia coli (Peer Reviewed)The authors present scale-up from a 5-L fermentor to a 50-L pilot-scale using the criterion of constant power consumption per unit liquid volume.
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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
Latest:
A Study of Leachables for Biopharmaceutical Formulations Stored in Rubber-Stoppered Glass VialsA systematic approach facilitates formulation component selection.
Latest:
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.
Latest:
Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
Latest:
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.
Latest:
Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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:
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.
Latest:
Biopharmaceutical Manufacturing Using Blow–Fill–Seal TechnologyThe authors give special consideration factors affecting blow–fill–seal technology.
