Search results for " variability"
Article
Impurity Testing of Biologic Drug Products
Validation of the method will then serve to confirm the robustness of these elements and assess the variability introduced by different analysts and equipment.
Both the number of replicat…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.
By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari
Recombinant protein products have…
Article
Being Thorough When Transferring Technology
Due to the inherent variability and complexity of biologics, the design space and strategy should take into account future scale-up considerations and risks. This can be met with qualified scale-down …
Article
Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Biop…
Article
Optimize Column Loading Strategy to Gain Productivity in Protein Purification
Are you looking for a way to improve productivity in your affinity chromatography step? Have you ever applied the concept of variable loading to gain productivity? By varying residence time (RT) ove…
Article
Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development.
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
C…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Given the variability of the phenotypic assessment, the current and preferred measure of suitability is to assess the genetic profiles of the production cell-line population, thus obtaining a measure …
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
Selecting a Comprehensive Bioburden Reduction Plan
Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination.
By Randi Hernandez
There are multiple variables to consider …
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
This article discusses cleaning validation of equipment dedicated to the production of a single API.
By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chi…