Search results for " specification" in Articles / App Notes
Article
Scaling Up Novel Therapies
“Not only strong process monitoring and control, but highly relevant assays are needed to ensure that clinically relevant product specifications are met. Where these are on-line or at-line, a high deg…
Article
Transformative Medicines Challenge FDA and Manufacturers
…rmation Association (DIA), experts explored strategies for tackling quality risk management, setting specifications, and assuring compliance with chemistry, manufacturing, and control (CMC) standards…
Article
Roadmap Leads to Innovative Biomanufacturing Strategies
Roadmap Leads to Innovative Biomanufacturing Strategies
The Biomanufacturing Technology Roadmap is accelerating innovative manufacturing strategies for biopharmaceuticals.
By Feli…
Article
Platform Technologies Improve Protein Expression
Platform technologies facilitate development and accelerate commercialization of protein therapeutics.
By Cynthia A. Challener
Speed to market is essential in the biopharmaceutica…
Article
Bioburden Control in the Biopharmaceutical Industry
Even if the product itself meets specifications, it is still considered “adulterated” if it was not manufactured under cGMP standards in a cGMP environment (5). This is also evident from warning lette…
Article
Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations.
By Cynthia A. Challener
Cell-culture and fermentation are high-…
Article
Fusion Proteins Pose Manufacturability Challenges
…ency of the candidate, is a key quality attribute and can be challenging to control within a desired specification,” he says.
To address this issue, it is necessary to identify suitable levers in…
Article
Critical Quality Attributes Challenge Biologics Development
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics.
By Susan Haigney
Critical quality attributes (CQAs) are used in biop…
Article
Perfusion in the 21st Century
Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.
By Bruce Lehr, Delia Lyons
Cell-culture technology for biopharmaceutical manufact…
Article
Managing Biomanufacturing Capacity Expectations
Capacity for complex therapeutics is becoming increasingly difficult to predict.
By Randi Hernandez
Demand for any given new product is typically only known after significant investments h…