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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.
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Tangential Flow Filtration for the Recovery of Acellular Pertussis Vaccine ComponentsMembrane-based TFF technology can ease scale-up and provide a higher recovery percentage compared to conventional purification methods.
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Outsourcing A Survival Strategy or a Tool for Speed to Market A Case StudyOutsourcing is becoming increasingly widespread and essential in the biopharmaceutical industry. Its imprint on biotech world business and on the development of biopharmaceutical drugs is becoming ever more pronounced. It is estimated that almost one-half of biopharmaceutical companies contract out at least part of the production of their products. On the other hand, those companies that do not outsource production often contract out some of their development activities.
