Authors
Latest:
US Regulation of Plant-made Biopharmaceuticals, Part 2In the first part of this feature (Jan. 2005) we discussed the technical background and the role that FDA, US Department of Agriculture (USDA), and Environmental Protection Agency (EPA) play in setting the rules for accepting plant-made biopharmaceuticals (PMBs). We now continue by discussing how producers will be able to take products to market.
Latest:
BMS or PLC? Controlling the Regulated EnvironmentIf the system is not 21 CFR Part 11-capable or the network configuration is not appropriate, cost is immaterial.
Latest:
Affinity Chormatography Removes EndotoxinsProtein solutions used for research, vaccines, or therapeutics need to be free of contaminants. One of the chief concerns is the presence of endotoxins (lipopolysaccharides) because their removal from protein solutions is a challenge. Typically, removal techniques utilize adsorption onto surfaces of beads in batch reactions, onto beads packed in columns, or onto membrane surfaces.
Latest:
Let There Be Light: Plant-Made Pharmaceuticals' New Home is UndergroundThe mine space is greater than the volume of all homes for a city of one million people. The second facility has been mapped at 22,500 acres.
Latest:
Characterization of TrypZean: a Plant-Based Alternative to Bovine-Derived Trypsin (Peer-Reviewed)An in-depth characterization of maize-derived trypsin revealed an unusual nonconsensus N-linked glycosylation.
Latest:
Advocating for Biosimilar Approval Standards Under BPCIFDA weighs multiple views regarding the Biologics Price Competition and Innovation Act.
Latest:
Disposable Bioreactors for Viral Vaccine Production: Challenges and OpportunitiesSwitching to single-use bioreactors can have financial and performance benefits.
Latest:
Operational Excellence: More Data or Smarter Approach?The authors focus on operational excellence in manufacturing of biotechnology therapeutic products in the QbD paradigm.
Latest:
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?
Latest:
Advocating for Biosimilar Approval Standards Under BPCIFDA weighs multiple views regarding the Biologics Price Competition and Innovation Act.
Latest:
Nontuberculosis Mycobacterium Contamination of a Mammalian Cell Bioreactor ProcessThe authors present a case study identifying a contaminant.
Latest:
The Powerful Lesson of the GSK–Whistleblower CaseThose at the top must walk the walk of uncompromising commitment to compliance
Latest:
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.
Latest:
Biopharmaceutical High PerformanceIndustry may be its own obstacle to success in achieving the desired high-performance state.
Latest:
Addressing the Challenges in Downstream Processing Today and TomorrowNewer classes of biotherapies will require innovations in processing technology.
Latest:
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.
Latest:
Biopharmaceutical High PerformanceIndustry may be its own obstacle to success in achieving the desired high-performance state.
Latest:
Accelerating Bioprocess OptimizationA series of advancements has changed the way bioprocesses are developed and optimized.
Latest:
Characterizing Biologics Using Dynamic Imaging Particle AnalysisOvercoming limitations of volumetric techniques and detecting transparent particles.
Latest:
Challenging the Cleanroom Paradigm for Biopharmaceutical Manufacturing of Bulk Drug SubstancesThe authors re-examine environmental controls in the context of technical advances in manufacturing.
Latest:
Getting Better at Making StuffTo achieve manufacturing excellence, biopharma companies must adopt four key operating principles.
Latest:
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.
Latest:
Disposable Bioreactors for Viral Vaccine Production: Challenges and OpportunitiesSwitching to single-use bioreactors can have financial and performance benefits.
Latest:
Addressing the Challenges in Downstream Processing Today and TomorrowNewer classes of biotherapies will require innovations in processing technology.
Latest:
Organizational Structures of Process Development and Manufacturing SupportHow to strike a balance between site autonomy and global coordination.
Latest:
Practical Considerations for Demonstrating Drug Substance UniformityThe authors describe considerations and best practices for meeting drug substance uniformity.
Latest:
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.
Latest:
Systematic Approaches to Develop Chemically Defined Cell Culture Feed MediaMaking chemically defined media work.
