Search results for " process qualification" in Articles / App Notes
Article
Monitoring and Control of Inline Dilution Processes
He notes that metering pumps, particularly those that are servo controlled, more accurately and consistently blend buffer constituents to the exact molecular ratio that was defined in the original pro…
Article
Automating the Biomanufacturing Process
As automation in biomanufacturing becomes more important, so does the need to integrate process data.
By Feliza Mirasol
unlimit3d/Stock.Adobe.com
Biomanufacturing proc…
Article
Implementing Inline Conditioning to Advance Process Intensification
Buffer preparation is still a highly manual activity that often requires a lot of resources due to the large number and overall volume of buffers. With inline conditioning buffers can be prep…
Article
Technical and Process Economical Aspects of Using Capto™ Q and ReadyToProcess™Adsorber Q in mAb Polishing
Increasing product titers in upstream cell culture processes pose challenges to downstream purification processes. For efficient operations, downstream purification needs to be able to handle high p…
Article
Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
By Cynthia A. Challener
Manufacture of protein and other biologic drug substances via …
Article
Being Thorough When Transferring Technology
This sets the stage for successful process qualification. Due to the inherent variability and complexity of biologics, the design space and strategy should take into account future scale-up considerat…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
A…
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
In the third and final part of this article, the author applies the continuum of criticality for parameters and attributes to develop the process control strategy and study its influence on the proces…