Search results for " impurity"
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
Abstract
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Article
Re-use of Protein A Resin: Fouling and Economics
While all five of the parameters are used in the industry, yield is considered as the most important, followed by impurity levels, product quality, chromatographic profile, and HETP. Other than these …
Article
Tackling Analytical Method Development for ADCs
Feb 01, 2015
By Cynthia Challener, PhD
BioPharm International
Volume 28, Issue 2
The targeted therapy possible with antibody-drug conjugates (ADCs) makes them an attractive class of …
Article
A Closer Look at Affinity Ligands
This reduces the resin lifetime and introduces a process related impurity into the product mainstream. Leached protein A is considered a CQA (critical quality attribute) to measure for with a release …
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
Chromatography for the Diversified Antibody Pipeline
CytivaVideo
In this video, Eva Heldin, Section Manager of Antibody Application in R&D at Cytiva is interviewed by BioPharm International and shares what antibody therapies are in the pipelin…
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
Optimizing Late-Stage and Commercial Cell-Culture Processes
Optimizing Late-Stage and Commercial Cell-Culture Processes
Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.
By Feliza Mirasol
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Article
Evaluating E&L Studies for Single-Use Systems
It is presumed that any impurity entering the production stream can have a negative impact on the product quality and the severity of such a failure mode is considered to be high. A process-specific a…
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…