Search results for " control"
Poster
A Next Generation Protein A Chromatography Resin for Improved Productivity and Bioburden Control
mAb production using a Protein A capture step has followed a highly successful synergistic path the last 30 years. There are, however, remaining challenges.
• The increased upstream titers in mA…
Article
Digitalization: The Route to Biopharma 4.0
The ultimate objective is to make an automated smart factory, wherein the process operations and control decisions are executed without human supervision. Such a setup offers multiple advantages, such…
Article
QbD and PAT in Upstream and Downstream Processing
For biological products, process control can be difficult to define and implement. O2 pressure, catalyst concentration, and pH are examples of critical parameters. It is important to note that mAbs ar…
Article
Assessing Manufacturing Process Robustness
…recalls
field alert report
product complaints
change control
stability reports
product development report
…
Article
Automating Processes in Upstream Processing
BioPharm: What should be considered when developing strategies for process control in upstream processing?
Marshall: The bioreactor or fermenter is the upstream equipment that has the most control…
Article
Improving PAT for Biologics
“Effective PAT implementation implicates the use of various measurement and control devices and hence requires a commitment to sophisticated automation solutions,” says Mario Becker, director of marke…
Article
Essentials in Quality Risk Management
An effective QRM process can further ensure the high quality of the drug product to the patient by providing a proactive means to identify and control potential risks to quality during development and…
Article
Regulatory Challenges in the QbD Paradigm
This decline in success rate, along with the increasing scrutiny of healthcare costs in developed economies, has resulted in unrelenting pressure on the pharmaceutical companies to control drug-develo…
Article
Moving PAT from Concept to Reality
In-line and on-line sensors allow for continuous process measurement and control, while at-line measurements cause a delay between sampling and availability of the results, preventing their use for di…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
48-64
The quality-by-design principles that enable a manufacturer to limit and control the sources of process variability are equally important to measurement systems, because the variability in …