Search results for " aggregation"

Article Ensuring Viral Safety of Viral Vaccines and Vectors
Moreover, conditions should be adjusted to avoid aggregation or complex formation of therapeutic viruses and, thus, product loss. Chromatographic methods are potentially effective tools for adv…

Article ADC Development Robust Despite Lackluster Performance
Because its polymer is highly water soluble, it can be used to surround the cytotoxic payload and compensate for the payload’s poor solubility, thus minimizing aggregation and maintaining the ADC’s st…

Poster Rapid Process Development of a CIEX Step for a Biosimilar
When establishing purification processes for a biosimilar molecule it is important to develop steps that are scalable, selective, and cost-effective. A cation exchange (CIEX) chromatographic ste…

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
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures. By Cynthia A. Challener Manufacture of protein and other biologic drug substances via …

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
Constantly removing the product from the bioreactor reduces the retention time of the protein, a key improvement under production conditions that facilitate aggregation and degradation of the biologic…

Article Selecting the Right Viral Clearance Technology
…grity of the protein product, which can be a challenge because physiochemical methods can induce the aggregation, fragmentation, or other undesired effects on some molecules. It is essential to have …

Article Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
Therapeutic monoclonal antibodies represent one of the fastest growing segments in the pharmaceutical market. The growth of the segment has necessitated development of new efficient and cost saving …

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