Search results for " control"
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
With the most recent FDA (1) and Inter-national Conference on Har-monization (ICH) guidances (2-4) advocating a new paradigm of process validation based on process understanding and control of paramet…
Article
Monitoring and Control of Inline Dilution Processes
An effective evaluation will include investigation of the total cost of ownership, including space requirements, future expansion plans, labor costs, and quality control, among other factors. “I…
Article
Leveraging Data for Better Biopharmaceutical Process Control
For many years, though, extending this approach into true process analytical technology (PAT) and using it to track and control processes was done mainly in the research lab.
Recently, there ha…
Article
Bioburden Control in the Biopharmaceutical Industry
…and Bacteroides fragilis, among others that should not be overlooked in microbiological quality control (2). Moreover, determination and identification of the nature and relative densities of microbi…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Options for eliminating the detrimental effects of bDtBPP include complete removal of TBPP from the formulation, controlling TBPP oxidation through modulation of film manufacturing parameters, or usin…
Article
QbD Improves Cell-Culture Process Control
Real-time quality control
Integrating process analytical technology (PAT) into the bioproduction process enables the biomanufacturer to move from a quality-by-testing approach to a QbD approach, w…
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Biopharmaceutical manufacturers thus face a huge hurdle in bringing more advanced manufacturing and process control methods to the manufacture of cell and gene therapies. “New approaches will be neede…
Article
Host-Cell Protein Measurement and Control
For this reason, a risk control strategy is applied through the development of robust downstream bioprocess to remove HCPs to as low a evel as possible or to “undetectable” levels in drug substance/pr…
Resource
Get Confident: Inline Conditioning Control Modes
The control modes are the system’s dynamic feedback functionality. The course consists of both instructional videos and cases that give a deeper understanding of the control modes.
Article
Get Confident: Inline Conditioning Control Modes
The control modes are the system’s dynamic feedback functionality. The course consists of both instructional videos and cases that give a deeper understanding of the control modes.