Search results for " elemental impurities"

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 Evaluating E&L Studies for Single-Use Systems
…troscopy (GF/AAS) for silicone • Inductively coupled plasma-mass spectrometry (ICP-MS) for elemental impurities • Total organic carbon (TOC) on aqueous extracts only. On…

Article Re-use of Protein A Resin: Fouling and Economics
Mar 01, 2015 By Anurag S. Rathore, Mili Pathak, Guijun Ma, Daniel G. Bracewell BioPharm International Volume 3, Issue 28 In the past two decades, Protein A affinity chromatography ha…

Article Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 4 Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …

Article Digitalization: The Route to Biopharma 4.0
Industry 4.0, also known as the Fourth Industrial Revolution (4IR), will result in the digital transformation of the manufacturing sector. It is propelled by transformative trends such as the prolif…

Article Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency. By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore Virus-like…

Article Process Chromatography Selection for Downstream Processing Applications
Industry experts discuss best practices for selecting a separation technology. By Caroline Hroncich Process chromatography has changed significantly since it was first introduced to the biop…

Article Biopharma Advances Demand Specialized Expertise
Jun 15, 2015 By BioPharm International Editors BioPharm International eBooks Volume 28, Issue 13 Contract service providers share insights on biopharma market developments and the impl…

Article Use of Multivariate Data Analysis in Bioprocessing
Apr 06, 2015 By Anurag S. Rathore, Sumit K. Singh BioPharm International The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motiva…

Article Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes. By Susan Haigney natali_mis/Stock.Adobe.com Regulators have been en…

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