Search results for "aggregates "
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
…
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…
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
“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…