Authors
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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.
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Quality Management Systems for Small Biopharmaceutical OrganizationsWhat small biotechs need to know about quality management systems.
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Strategies for Optimizing the CMO-Client RelationshipPartner with a contract manufacturing organization that integrates best practices from project management, customer service, and Lean.
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Myriad Decision Places Biotech at a CrossroadsIn light of the new ruling, patent licensees may want to re-evaluate the strength of their licensed patents.
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Quality by Design: The Case for Change (Part II)A rigorous cost-benefit assessment can help to chart a cost-effective path forward.
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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.
