Search results for " control"
Article
Sources of Bioburden You Might Have Missed
A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.
The risk …
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
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
For complex unit operations such as process chromatography, mechanistic modeling can assist in developing a systematic approach for process development, monitoring, and control. Models can also be jud…
Article
HTPD: Optimizing a mAb Chromatography Polishing Step
In addition, steadily increasing demands from regulatory authorities for better understanding and control of manufacturing processes put even more pressure on development work. High-throughput process…
Article
Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
The year ahead is expected to be marked by increased biosimilar development, lower drug prices, and better quality drugs.
The global biopharmaceuticals market was valued at $162 billion in 2014 a…
Article
Managing Risk in Raw Material Sourcing
…ffect analysis, fishbone diagrams, and fault tree analysis, as well as hazards analysis and critical control point techniques, says Ohri. The company has established sites in the United States, Europ…
Article
Advancing Single-Use Technology Through Collaboration
Efforts toward standardizing the supplier change control and change notification processes, as well as standardizing user requirements, have also been initiated as joint efforts between end users with…
Poster
Improve operational efficiency in biomanufacturing with comprehensive automation solutions
Often this connection is discontinuous, meaning equipment is controlled on an instrument-level, resulting in islands of automation. This white paper outlines how connectivity and comprehensive automat…
Article
A Q&A with Eric Langer: CMOs Embrace New Technology
In comparison, biopharmaceutical innovators sought improved analytical assays and development, control systems, fill-finish services, and downstream PD services.
Why are CMOs early adopters?
…
Article
Generating a Fully Processed Antibody
By controlling the number of retrovector particles accessing the cell, multiple gene insertion can be achieved without any of the traditional amplification steps (8). This was important for this study…