Authors
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Quality Agreements for Contract ManufacturersA well-constructed quality agreement can be an important tool to enable effective collaboration between owner and CMO.
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Vector Manufacturing and Testing for Gene and Cell Therapy ApplicationsThe authors offer insight into cell therapy manufacturing, vector production, and the safety aspects of testing for characterization.
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Single-Use Bioreactors for the Rapid Production of Preclinical and Clinical BiopharmaceuticalsFed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.
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Single-Use Bioreactors for the Rapid Production of Preclinical and Clinical BiopharmaceuticalsFed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.
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Setting Standards for Biotech Therapeutics in IndiaThe authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.
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Assessing a Risk Management ProgramProgram review can help quality risk management live up to the promise of ICH Q9.
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Continued Process Verification for Biopharma ManufacturingThe authors discuss complications of implementing continued process verification and provide recommended approaches.
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Bolstering Graduate Education and Research ProgramsAAPS supports graduate-level programs impacted by cutbacks in funding and resources.
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A Review of the Challenges of Delivering Macromolecule BiologicalsSelecting a delivery method early on may be beneficial.
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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.
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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.
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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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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.
