Search results for " variability"
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, …
Article
Viral Clearance Challenges in Bioprocessing
Challenges remain for virus removal and validation.
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 42-44
Removal and inactivation of adventitio…
Article
Evaluating Design Margin, Edge of Failure and Process
Design space generation is encouraged in new product development.
Sep 1, 2014
By: Thomas A. Little, PhD
BioPharm International
Volume 27, Issue 9, pp. 46-49
A product’s or proc…
Article
Q&As with Industry Leaders
…;Strategic Technology Partnerships Leader, Cytiva
What's in Your Media? How Costly is Variability of Cell Culture Media to Your Manufacturing Process?
Megan Manzano, BioPharm Interna…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The biosimilars market, many analysts believe, is on the cusp of significant growth. This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expect…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the European Medicines Agency (EMA) firs…