Search results for " control" in Articles / App Notes
Article
Optimization of Protein Expression in Escherichia Coli
It carries the phage T7 gene 1—encoding T7 RNA polymerase—in its chromosome under the control of the lacUV5 promoter. Protein expression can be induced with the addition of isopropyl β-D-1-thiogalacto…
Article
Continuous Chromatography: Trends, Definitions and Approaches
Can you comment on the importance of process development and control in the continuous process?
Process development and control are the two very important aspects related to continuous chromatogra…
Article
Securing the Single-Use Supply Chain
In the past, when drugs were manufactured in stainless steel, the manufacturer was in control of the infrastructure once its facility was in place, sourcing only critical disposable components such as…
Article
Raw Material Variability
In this case, it might be extremely difficult to control variability due to environmental factors. Changing to a chemically defined material would be preferred but is not always possible for legacy pr…
Article
The Affordable Care Act's Impact on Innovation in Biopharma
In the current environment, and especially in locations where hospital systems already control significant market share, moving quickly will enable them to lead in creating and controlling ACOs. The r…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Appropriate control of CQAs is a common review concern for both investigational new drug (IND) and license applications.6,7 Product quality characteristics encompass a wide variety of product variants…
Article
What’s in your media? How costly is variability of cell culture media to your manufacturing process?
It helps create a good dialogue between the vendors and us in order to understand where the variations are derived from—as well as how to control them and track them over a period of time.
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Article
Leveraging Computational Models of Glycosylation for Biopharma QA
Four QA application areas stand out: (i) data analytics, (ii) bioprocess characterization, (iii) cell line engineering/development, and (iv) manufacturing bioprocess optimization and control.
Kine…
Article
Understanding Validation and Technical Transfer, Part 2
A controlled, double-blind study should be conducted to determine which coffee the majority of
tasters prefer to obtain a definition of “good-tasting coffee.” To have a meaningful result, the b…
Article
Understanding Validation and Technical Transfer, Part I
Process validation is documented process understanding and control that begins when it is determined that a cell, molecule, or compound may have clinical significance and ends when the product is no l…