Authors
Latest:
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).
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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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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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Fermentation Process Technology Transfer for Production of a Recombinant Vaccine ComponentThe authors describe challenges faced in transfer and scale-up of a fermentation process.
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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Protein Characterization Through the StagesBiomanufacturers should follow a risk-based approach to decide which methods to use to characterize their products.
Latest:
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:
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:
A Study of Leachables for Biopharmaceutical Formulations Stored in Rubber-Stoppered Glass VialsA systematic approach facilitates formulation component selection.
Latest:
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:
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).
Latest:
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:
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).
Latest:
Scale-Up and Comparison Studies Evaluating Disposable Bioreactors and ProbesProcess performance was comparable across all scales, and fiber optic sensors appeared interchangeable with conventional probes.
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How to Reap the Benefits of Insourcing Contract Staff While Minimizing the RisksInsourcing is new outsourcing. Here's how to do it right.
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Scale-Up and Comparison Studies Evaluating Disposable Bioreactors and ProbesProcess performance was comparable across all scales, and fiber optic sensors appeared interchangeable with conventional probes.
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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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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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Scale-Up and Comparison Studies Evaluating Disposable Bioreactors and ProbesProcess performance was comparable across all scales, and fiber optic sensors appeared interchangeable with conventional probes.
Latest:
How to Shift from Reactive Compliance to Strategic Quality ManagementA culture of quality that emphasizes business objectives, risk management, and the informed application of technology can improve compliance.
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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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A Review of Sterile ConnectorsMany factors must be considered when choosing a sterile connector for a given process.
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Capturing Conformational Changes in Biotherapeutics by Hydrogen Deuterium Exchange and UHPLC–MSBy providing information on the relative accessibility of locations within a protein, HDX by mass spectrometry opens new windows into the higher order structure of biomolecules.
