Search results for " standardization" in Articles / App Notes

Article Biosimilar Quality Requirements
This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosi…

Article Best Practices for Selecting a Top-Quality Cell Line
Irina Shi - Stock.Adobe.com Leveraging automation and a step-by-step approach are keys to success. By Cynthia A. Challener Cell lines determine the performanc…

Article Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…

Article Cell-Culture Advances Test Bioreactor Performance Models
The evolution of cell-culture technology is driving the need for improvements in modeling solutions. By Cynthia A. Challener  Modeling and simulation are recognized to provide assistance i…

Article Single-Use for Downstream Chromatography: Benefit or Hindrance?
Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption. By Feliza Mirasol ARTMOIS/STOCK.ADOBE.COM Biopharmaceutical manufactu…

Article Supply Chain Challenges for Single-Use Systems
Suppliers address the complexity of supplying disposable components to the global biopharmaceutical manufacturing industry. By Jennifer Markarian  The implementation of sing…

Article Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
The biopharmaceutical industry continues to expand in new and exciting ways. What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back …

Article A Look at the Affinity Chromatography Landscape
A Look at the Affinity Chromatography Landscape New ligands are being developed to meet the separation and purification needs of next-gen biologics. By Cynthia A. Challener …

Article Scaling Up Novel Therapies
In addition, they permit some degree of facility design standardization, improving operational flexibility and capital savings, he says. Developers are exploring how these platforms might…

Article Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs Analytical exoglycosidases are transitioning from being largely academic tools to being s…

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