Search results for " Quality control"
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle. With the most recent FDA …
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…
Leveraging Data for Better Biopharmaceutical Process Control
Leveraging Data for Better Biopharmaceutical Process Control The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and dow…
Bioburden Control in the Biopharmaceutical Industry
…pecies, 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…
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…
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
As she noted, biopharmaceutical manufacturers need to move from offline to real-time testing, to reduce the complexity of multiple measurements and make quality control (QC) testing as noninvasive wit…
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The authors review efforts to limit polymer degradation without significantly impeding cell growth. Jan 01, 2015 By Sara Ullsten, Shujian Yi, Jeffrey Carter, Eva Lindskog, Pokon Ganguli, Her…
Are You in Control of the Quality of Your mAbs?
Sign up to view an on-demand recording and receive a free copy of our poster booklet, Better Biotherapeutic Characterization for Improved Quality Control. Enjoy!
Host-Cell Protein Measurement and Control
Jun 01, 2015 By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem BioPharm International Volume 28, Issue 6, pg 32–38 Host-cell proteins (HCPs) constitute a major part of proce…
Controlling Cell Culture Process Variability Through Supplier-Enabled Data Management and Analytics
In drug development and manufacturing, variability in raw materials presents high risks to the success of processes and products. When raw material variability issues arise, manufacturers and supplier…