Search results for "aggregates " in Articles / App Notes

Article ADC Development Robust Despite Lackluster Performance
ADC Development Robust Despite Lackluster Performance Despite the disappointing therapeutic performance of ADCs thus far, the pipeline still boasts promising prospects. By Feliza…

Article Best Practices for Data Integrity
Best Practices for Data Integrity Optimize practices and meet requirements using electronic data integrity systems. By Jennifer Markarian Maintainin…

Article Managing Residual Impurities During Downstream Processing
“It is essential, therefore, to develop online upstream and downstream monitoring systems for key process and product impurities, including product degradents, aggregates etc., such that if necessary,…

Article Downstream Processing for Cell-Based Therapies
By Qasim A. Rafiq, Fernanda Masri With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and late-stage clinical development, significant focus has been …

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 Perfusion in the 21st Century
Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing. By Bruce Lehr, Delia Lyons Cell-culture technology for biopharmaceutical manufact…

Article Selecting the Right Viral Clearance Technology
By Cynthia Challener, PhD The introduction of adventitious viral agents is a recognized, inherent risk of biologic drug production that is well addressed by international regulatory requirements…

Article Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
Moreover, the automated process reduced by 3-fold the amount of residual aggregates in the purified antibody fractions, indicating that the automated system allows the cost-efficient and timely prepar…

Article A Q&A With Prof. Alois Jungbauer: The Role of HIC in Biotech
Process Development Forum speaks with Professor Alois Jungbauer, Department of Biotechnology, BOKU, Vienna, about Hydrophobic Interaction Chromatography (HIC). What is your view of HIC in the bi…

Article Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed. Jul 01, 2015 By Susan Haigney BioPharm International Volume 28, Iss…

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