Search results for " attribute"
Article
Improving PAT for Biologics
“Real-time in-process measurements of critical quality and performance attributes of raw and in-process materials and processes are not always possible for biologics due to the complex nature of most …
Article
Application of Quality by Design to Viral Safety
A QbD approach to drug development starts with the definition of critical quality attributes (CQA) that the final drug product will possess, and then outlines the development path to achieve these goa…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Statistical models of these results were developed for each method attribute and used to define the variable ranges over which the method is expected to meet the predefined criteria in Table I. These …
Article
Raw Material Variability
Common examples would be out of specification for a product critical quality attribute (CQA), slower cell growth, low titer, and evidence of extraneous matter following visual inspection.
Fixing…
Article
Manufacturers Struggle with Breakthrough Drug Development
27, 2014) that breakthrough drug development requires information on critical quality attributes, potential scale-up strategies, comparability exercises, and validation plans. FDA will want to know ho…
Article
The Lifecycle Change of Process Validation and Analytical Testing
…ical testing (PAT) technologies to support the monitoring and control of product critical to quality attributes. I think material understanding throughout the manufacturing process from the product d…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology.
By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…
Article
Reviewing the Importance of Biosimilarity and Interchangeability
Analytical methods should thus be chosen or developed to compare critical quality attributes (CQAs) between the biosimilar and the reference product. “This involves assessing the physicochemical prope…
Article
A Closer Look at Affinity Ligands
Leached protein A is considered a CQA (critical quality attribute) to measure for with a release specification that must be met before the product can be released.Much progress has been made in recent…
Article
Paring Down Impurities in Downstream Processing
Myriad choices confront manufacturers before they even consider optimizing downstream processes. Each decision directly influences what final options will be available on arriving at the final…