Search results for " process control"
Article
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…
Poster
Modes of controlling charge variant distribution in Mab production
The characteristics of a biological drug, for example, charge variant profile, are determined to a large extent by the upstream expression system and conditions, but can also be influenced by the pu…
Webcast
Controlling Cell-Culture Process Variability
Impurities in raw materials are a risk to your cell productivity and protein quality. That is why we created a transparent, multi-source supplier network for cell-culture materials.
Article
Challenge Analytical Complexity: Biacore™ SPR Systems for Candidate Selection, Characterization, and Quality Control
This webinar presents the utility of Biacore™ systems at all stages of the process, from selection of first candidates to clinical lead, as well as how to shorten and streamline the time to results …
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
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
Continuous Manufacturing: A Changing Processing Paradigm
… of the fact that continuous manufacturing reduces manual handling of products and allows for better process control. An agency representative said at an International Forum and Exhibition on Process…
Article
Digitalization: The Route to Biopharma 4.0
A more common approach is to combine DCS with PLC/SCADA (18) to design a platform that can automate data pre-processing and analysis, reduce human intervention, automate process control, and perform f…
Article
Understanding Validation and Technical Transfer, Part 3
Once the process has been validated, routine process control records, measurements of critical process parameters, and CQAs will serve as a basis for deciding whether changes are necessary. Mult…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
For CPPs, a continuum of criticality allows for process control and monitoring strategies to focus where the greatest impact on product quality is achieved.
Quality risk management
Ri…