Authors
Latest:
New Binary Gas Integrity Test Improves Membrane Quality AssuranceThe authors developed a test for defects in filter membranes.
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Addressing the Challenges in Downstream Processing Today and TomorrowNewer classes of biotherapies will require innovations in processing technology.
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Disposable Bioreactors for Viral Vaccine Production: Challenges and OpportunitiesSwitching to single-use bioreactors can have financial and performance benefits.
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Track-and-Trace Progress Benefits Supply-Chain Security EffortsThe industry has made great strides in implementing serialization technologies, while technology developers are enabling more open access to real-time transportation data.
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Ireland: The Gateway to Biopharma's FutureDespite recent changes in corporate tax law, Ireland remains a valuable and attractive partner in the development and manufacture of biopharmaceuticals.
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Disposable Bioreactors for Viral Vaccine Production: Challenges and OpportunitiesSwitching to single-use bioreactors can have financial and performance benefits.
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Trends in PrefillsAn interview with Oskar Gold, vice-president, key account management and corporate marketing, at Vetter.
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Review of Orthogonal Methods to SEC for Quantitation and Characterization of Protein AggregatesThe use of orthogonal methods to SEC is discussed and examples are presented showing how analytical ultracentrifugation, AF4, and SEC compare in aggregate quantitation.
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Review of Orthogonal Methods to SEC for Quantitation and Characterization of Protein AggregatesThe use of orthogonal methods to SEC is discussed and examples are presented showing how analytical ultracentrifugation, AF4, and SEC compare in aggregate quantitation.
Latest:
Review of Orthogonal Methods to SEC for Quantitation and Characterization of Protein AggregatesThe use of orthogonal methods to SEC is discussed and examples are presented showing how analytical ultracentrifugation, AF4, and SEC compare in aggregate quantitation.
Latest:
Review of Orthogonal Methods to SEC for Quantitation and Characterization of Protein AggregatesThe use of orthogonal methods to SEC is discussed and examples are presented showing how analytical ultracentrifugation, AF4, and SEC compare in aggregate quantitation.
Latest:
Review of Orthogonal Methods to SEC for Quantitation and Characterization of Protein AggregatesThe use of orthogonal methods to SEC is discussed and examples are presented showing how analytical ultracentrifugation, AF4, and SEC compare in aggregate quantitation.
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A Next Generation of Quality ManagementThe author proposes a quality management system that uses the power of executive management to promote a positive quality culture.
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Challenging the Cleanroom Paradigm for Biopharmaceutical Manufacturing of Bulk Drug SubstancesThe authors re-examine environmental controls in the context of technical advances in manufacturing.
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Industrialized Production of Human iPSC-Derived Cardiomyocytes for Use in Drug Discovery and Toxicity TestingThe authors describe an industrialized process for the manufacture of iPSC-derived human cardiomyocytes.
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Time to Revisit Supplier Quality ManagementBest practices to strengthen supplier quality management.
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The Quality Product Steward Model: The Genentech ApproachA successful QPS acts as a single point of contact for consistent product quality oversight.
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Perspectives in MicroRNA TherapeuticsThe authors provide insight into microRNA biology, and the simplicity of anti-miR oligonucleotide drug delivery.
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Implementing Single-Use Technology in Tangential Flow Filtration Systems in Clinical ManufacturingA case study evaluates the performance, control of operations, productivity, and cost savings of a single-use system.
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Perception and Costs of Biotech InnovationThe lower price of biosimilars will increase patient access to medicines and spur innovation.
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Evaluation of a Single-Use Bioreactor for the Fed-Batch Production of a Monoclonal AntibodyDespite different material, agitation, and aeration, the performance of the disposable bioreactor is similar to that of stainless steel bioreactors.
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The Quality Product Steward Model: The Genentech ApproachA successful QPS acts as a single point of contact for consistent product quality oversight.
Latest:
Challenging the Cleanroom Paradigm for Biopharmaceutical Manufacturing of Bulk Drug SubstancesThe authors re-examine environmental controls in the context of technical advances in manufacturing.
Latest:
Benefits of a Revised Approach to Anion Exchange Flow-Through Polish ChromatographyA high-performance anion exchange resin performs well compared with membranes. In addition, the resin offers greater flexibility and cost savings.
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Evaluation of a Single-Use Bioreactor for the Fed-Batch Production of a Monoclonal AntibodyDespite different material, agitation, and aeration, the performance of the disposable bioreactor is similar to that of stainless steel bioreactors.
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and BetterTraditional project decision-making vs. a QbD approach.
