Authors
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Key Considerations in Biosimilars DevelopmentUnderstanding opportunities and challenges across all major phases of development.
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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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Technology Integration: Enhancing QA and Compliance in Biopharmaceutical ManufacturingWhen developing a strategy for using technology in biopharmaceutical manufacturing, include the interaction between automation and business systems and the roles they play in enhancing quality assurance and compliance.
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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.
