Search results for "aggregates "

Article Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.  By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani  Drug development is …

Article Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations. By Cynthia A. Challener Cell-culture and fermentation are high-…

Article HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time. ABSTRACT Monoclonal antibodies represent a significant portion of sales in the biopharma…

Article QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…

Article Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Sterility must be assured for all biologic drug products. Terminal sterilization achieved via treatment with heat, radiation, or certain chemicals (vaporous hydrogen peroxide, vaporous peracet…

Article Addressing the Complex Nature of Downstream Processing with QbD
“An example is the topic of product aggregates that can trigger immunogenic responses. It is therefore common to reduce aggregate content to below a threshold value using cation exchange, multimodal c…

Article Leveraging Data for Better Biopharmaceutical Process Control
Leveraging Data for Better Biopharmaceutical Process Control The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and dow…

Article Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins This study outlines methods for an alternative protein-polishing process for challenging proteins. …

Article Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists. By Randi Hernandez When human cells travel throug…

Article Antibody Production in Microbial Hosts
coli, the Sec-dependent pathway has been used for protein secretion because of its abundance, although accumulation of protein aggregates may occur due to the generation of premature proteins before s…

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