Authors
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Operational Excellence: More Data or Smarter Approach?The authors focus on operational excellence in manufacturing of biotechnology therapeutic products in the QbD paradigm.
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Biosimilars Regulation in the US: The ChallengesThe pathway for biosimilar approval in the US has been set. But are US patients too far behind Europe?
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Advocating for Biosimilar Approval Standards Under BPCIFDA weighs multiple views regarding the Biologics Price Competition and Innovation Act.
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Nontuberculosis Mycobacterium Contamination of a Mammalian Cell Bioreactor ProcessThe authors present a case study identifying a contaminant.
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The Powerful Lesson of the GSK–Whistleblower CaseThose at the top must walk the walk of uncompromising commitment to compliance
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Benefits of a Revised Approach to Anion Exchange Flow-Through Polish ChromatographyA high-performance anion exchange resin performs well compared with membranes. In addition, the resin offers greater flexibility and cost savings.
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Biopharmaceutical High PerformanceIndustry may be its own obstacle to success in achieving the desired high-performance state.
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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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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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Biopharmaceutical High PerformanceIndustry may be its own obstacle to success in achieving the desired high-performance state.
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Accelerating Bioprocess OptimizationA series of advancements has changed the way bioprocesses are developed and optimized.
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Characterizing Biologics Using Dynamic Imaging Particle AnalysisOvercoming limitations of volumetric techniques and detecting transparent particles.
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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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Getting Better at Making StuffTo achieve manufacturing excellence, biopharma companies must adopt four key operating principles.
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An Economic Analysis of Single-Use Tangential Flow Filtration for Biopharmaceutical ApplicationsSingle-use TFF offers the greatest savings in clinical and contract manufacturing, where the scale is low and changeovers are frequent.
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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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Addressing the Challenges in Downstream Processing Today and TomorrowNewer classes of biotherapies will require innovations in processing technology.
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Organizational Structures of Process Development and Manufacturing SupportHow to strike a balance between site autonomy and global coordination.
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Practical Considerations for Demonstrating Drug Substance UniformityThe authors describe considerations and best practices for meeting drug substance uniformity.
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Analysis of PEGylated Protein by Tetra Detection Size Exclusion ChromatographyReliably detecting low amounts of high molecular weight impurities during process development and characterization of biopharmaceutical products.
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Systematic Approaches to Develop Chemically Defined Cell Culture Feed MediaMaking chemically defined media work.
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Perspectives in MicroRNA TherapeuticsThe authors provide insight into microRNA biology, and the simplicity of anti-miR oligonucleotide drug delivery.
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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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Efficient Multiproduct Process Development Case StudyAchieving multiproduct development within shortened timelines.
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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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Public–Private Partnerships: Life-Saving Mechanisms of ActionManaging partnerships for the greater good.
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Single-Domain Antibodies for Brain TargetingSingle-domain antibodies are emerging as credible alternatives due to their target specificity, high affinity, and cost-effective recombinant production.
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Standardizing Practices for Cellular Therapy ManufacturingCellular therapy developers learn process development strategies from pharma industry experiences.
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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.
