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Latest:
Development of Purification for Challenging Fc-Fusion ProteinsThis study outlines methods for an alternative protein-polishing process for challenging proteins.
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Considerations for Scale-Up Stem-Cell CulturesScaling up stem-cell cultures requires careful consideration of the bioreactor design.
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Evaluation of Single-Use Fluidized Bed Centrifuge System for Mammalian Cell HarvestingThis article discusses the evaluation of a novel single-use fluidized bed centrifuge for harvesting of antibodies.
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Development of an Alternative Monoclonal Antibody Polishing StepMAb polishing using salt tolerant interaction membrane chromatography.
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Development of a Full Process Train, Single-Use FacilityThis article describes best practices for implementing a single-use process train at a bioproduction facility.
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Bioanalytical Methods for Sample CleanupPreparation of biological samples for chromatographic analyses.
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Tools for Enabling Process Analytical Technology Applications in BiotechnologyThe authors review the various analytical methods that can enable use of PAT.
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Nuclear Magnetic Resonance as a Bioprocessing QbD ApplicationCurrent expectations in bioprocessing and a framework for using NMR to enhance a QbD approach.
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Correlating Product Lifecycle and Manufacturing Site Characteristics with Product DeviationsMIT survey results address product and site characteristics that statistically correlate with quality performance.
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Best Quality Practices for Biomedical R&DMembers from an ASQ working group provide analytical methods to enable PAT.
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Analysis of Glycosylation in BiosimilarsA step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
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What the 2011 Census of India Reveals for PharmaThe census reveals the state of the population of India's health and the potential for growth in the healthcare market.
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The Vaccine SceneA look at vaccine history, markets, manufacturing, and overcoming the scale-up dilemma.
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Partnerships Remain Crucial to Future DevelopmentWorking together affords many unseen opportunities for pharmaceutical innovation.
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Scale-up of Human Mesenchymal Stem Cells on Microcarriers in Suspension in a Single-use BioreactorDemonstration of large-scale stem-cell scale-up.
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Overcoming Challenges in the Reconstitution of a High-Concentration Protein Drug ProductThe authors present approaches used to reduce reconstitution time of a lyophilized high-concentration protein drug product.
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You Have Failed . . . A Case Study in Warning Letter Remediationby Joseph Noferi, Edward R. Arling, Ralph L. Dillon, and Mikael Blomqvist, Pharmacia An FDA Warning Letter can be a business disaster. This case study tracks a company from receipt of an FD 483 ? that did not find contamination, but only the potential for contamination ? to 18 months later when the facility received a clean bill of health. What it did to get there ? and what it learned ? may keep your site from losing its operating freedom.
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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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Correlating Product Lifecycle and Manufacturing Site Characteristics with Product DeviationsMIT survey results address product and site characteristics that statistically correlate with quality performance.
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Meeting Challenges for Analysis of Antibody-Drug ConjugatesThe complex structure of ADCs necessitates different analytical strategies than those for either small molecules or unconjugated monoclonal antibodies.
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A Case Study for the Inactivation of TSE Agents: Using an Alkaline Treatment in the Manufacturing Process of a Cell Culture Media SupplementBiopharmaceuticals are perceived as being at risk of transmitting spongiform encephalopathies to patients, although there has never been such an incident. Clearance studies such as the one described in this article (using a TSE model) can validate inactivation and enhance confidence in the safety of therapeutics produced using animal-derived cell culture supplements.
