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Latest:
A Study of Leachables for Biopharmaceutical Formulations Stored in Rubber-Stoppered Glass VialsA systematic approach facilitates formulation component selection.
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Review of SUT Adoption in Biopharma ManufacturingThe evolution of therapeutic modalities drives the adoption of single-use technologies.
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PEG Precipitation: A Powerful Tool for Monoclonal Antibody PurificationThis alternative purification method to chromatography is readily scalable and fits a fully disposable downstream process.
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Embedding a Culture of Continuous Improvement & Lean Manufacturing Across Pfizer Global ManufacturingEnabling site-wide process efficiency.
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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).
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Addressing Unmet Medical Needs Through Tailored Vaccine Design: The Importance of Adjuvant SystemsIt is now possible to combine antigens with specific adjuvant systems to create more effective vaccines.
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Meningitis Vaccine Manufacturing: Fermentation Harvest Procedures Affect PurificationCareful analysis of an unusual precipitate identifies defects.
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Quality Management Systems for Small Biopharmaceutical OrganizationsWhat small biotechs need to know about quality management systems.
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Effective Auditing of CMOsIt is important that all stages of the audit be given an equal measure of attention.
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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Using NMR Spectroscopy to Obtain the Higher Order Structure of Biopharmaceutical ProductsSimple methods can characterize polysaccharide vaccines and recombinant cytokines at high resolution.
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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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A Review of Sterile ConnectorsMany factors must be considered when choosing a sterile connector for a given process.
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Manufacturing Vaccines for the Developing WorldA handful of facilities making 200 million single-dose units per year could fast-track the immunization of the developing world.
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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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Advancing Vaccine Technology to Combat Global Pandemic ThreatsNew technologies such as virus-like particles are promising weapons in the battle against pandemic influenza.
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An Economic Comparison of Three Cell Culture TechniquesComparing the economic feasibility of a typical glycosylated protein.
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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).
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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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Analytical Tools for Process and Product CharacterizationSelect the best approach to determine critical quality attributes.
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High-Cell-Density Culture to Produce Plasmid DNA for Gene Therapy in E. coliHow to produce Plasmid DNA in a high-cell-density culture.
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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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.
