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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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Addressing Unmet Medical Needs Through Tailored Vaccine Design: The Importance of Adjuvant SystemsIt is now possible to combine antigens with specific adjuvant systems to create more effective vaccines.
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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.
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Biophysical Characterization for Product ComparabilitySpectroscopic methods such as circular dichroism can detect subtle differences in higher order structure before and after changes in process and formulation.
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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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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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Addressing Unmet Medical Needs Through Tailored Vaccine Design: The Importance of Adjuvant SystemsIt is now possible to combine antigens with specific adjuvant systems to create more effective vaccines.
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Site-Directed Engineering of Defined Chromosomal Sites for Recombinant Protein and Virus ExpressionMethod for integration of transgenes.
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MALDI-DIT Analysis of Modification Site of Chemically Modified AntibodyThis application note showcases the high MSn analysis capability of an ultra-compact MALDI digital ion trap (DIT) mass spectrometer, and its ability to obtain information from modified peptides.
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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).
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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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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Validation of Commercial-Off-the-Shelf Calibration Management Systems: Managing Instruments Cost-EffectivelyBiotech companies are among the most intensive instrumentation users of any FDA-regulated business. Because of the complex nature of these companies' research and manufacturing, they typically have a larger number of instruments per employee.
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Recent Patent Rulings Can Impede the Progress of Personalized MedicineThe Bilski and Classen decisions can render numerous in vitro diagnostic claims unpatentable.
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Use of Contract Analytical Laboratories: A Pfizer Global Biologics PerspectiveBy following key strategies, companies can reduce the risk and increase the benefits of outsourcing analytical development and testing
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An Alternative Platform for Rapid Production of Effective Subunit VaccinesAdjuvant activity can be greatly improved by appropriate formulation of cytosine-phosphorothioate-guanine oligodeoxynucleotides (CpG ODNs).
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Advancing Vaccine Technology to Combat Global Pandemic ThreatsNew technologies such as virus-like particles are promising weapons in the battle against pandemic influenza.
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Embedding a Culture of Continuous Improvement & Lean Manufacturing Across Pfizer Global ManufacturingEnabling site-wide process efficiency.
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Site-Directed Engineering of Defined Chromosomal Sites for Recombinant Protein and Virus ExpressionMethod for integration of transgenes.
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Using Fluorescence-Based Sensing to Accelerate Process DevelopmentA prove-free system monitors accurately at very small scale.
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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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A Quality Culture Can Be the Industry's Core StrengthHow should the industry educate the public about product quality?
