Search results for " variability" in Articles / App Notes
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…
Article
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…
Article
Biopharma Advances Demand Specialized Expertise
… Process analytical technology (PAT) for continuous monitoring of bioprocesses is helping reduce the variability on biopharmaceutical manufacturing.
Also, biopharmaceutical development and proces…
Article
Ensuring the Quality of Biologicals
May 02, 2015
By Stephen Wicks, PhD
Pharmaceutical Technology
Volume 39, Issue 5
The European Pharmacopoeia (Ph. Eur.), which celebrated its 50th anniversary in 2014, provides common …
Article
Re-use of Protein A Resin: Fouling and Economics
Mar 01, 2015
By Anurag S. Rathore, Mili Pathak, Guijun Ma, Daniel G. Bracewell
BioPharm International
Volume 3, Issue 28
In the past two decades, Protein A affinity chromatography ha…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
“Because of this variability in measurements using different techniques, it is usually necessary to use multiple, orthogonal techniques,” says Brown. According to Brown, there are no standard referenc…
Article
Securing the Single-Use Supply Chain
“These results indicated that the materials were comparable within the variability of the analytical techniques used,” Briggs says. He also recognizes that tubing is a universal single-use component, …