Authors
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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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Vaccine Packaging at the Clinical Interface of Vaccine, Healthcare Worker, and PatientPackaging vaccines using prefilled syringes can increase dosing efficiency, reduce costs, and improve patient safety. This article is part of a special section on vaccines.
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Putting Risk-Based Decision-Making Where It BelongsFocusing on how risk affects the entire organization can improve the business bottom line.
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Bringing Innovation to Neglected Disease R&DA new report highlights the industry's contributions to neglected diseases and calls for further collaboration.
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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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Integration of a Single-Use Platform Process within an Innovative Facility DesignThe combination of single-use platform technology with modular facility construction is a template for flexible manufacturing.
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Bioprocess Manufacturing Tool Preview: A First Look at ISPE's Baseline Guide for BiopharmaceuticalsWith the biotechnology industry in the early phases of commercialization, many bioprocess companies are just beginning to build and operate commercial-scale production facilities.
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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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Key Considerations in Biosimilars DevelopmentUnderstanding opportunities and challenges across all major phases of development.
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Biologics: Can There Be Abbreviated Applications, Generics, or Follow-On Products?In this question-and-answer discussion of "generic" biologics, the authors contend small changes in manufacturing of biologics dramatically affect the safety and efficacy of the therapeutic molecule.
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Reduce Analytical Testing and Costs Without Compromising ComplianceUnnecessary analytical testing can lead to unnecessary costs.
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Analyzing the Best Fit for a FacilityA brief case study of a facility-fit analysis provides insight into how to adjust capacity when moving from clinical-to commercial-scale production.
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Rapid Assessment of Molecular Similarity between a Candidate Biosimilar and an Innovator Monoclonal Antibody Using Complementary LC–MS MethodsIntact protein LC–MS detected a mass variance of 62 Da and peptide mapping located a difference of two amino acids.
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The Affordable Care Act's Impact on Innovation in BiopharmaThe biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare.
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Site-Directed Engineering of Defined Chromosomal Sites for Recombinant Protein and Virus ExpressionMethod for integration of transgenes.
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Managing CMOs with Complementary CapabilitiesFormulation strategy is an important consideration when selecting and managing outsourced biopharmaceutical development programs.
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Site-Directed Engineering of Defined Chromosomal Sites for Recombinant Protein and Virus ExpressionMethod for integration of transgenes.
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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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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.
