Search results for " stability" in Articles / App Notes
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Figure 1: Changes of critical quality attributes, such as high-order structure, amino acid modifications, glycosylation, and stability might impact binding activity and concentration. All figures are …
Article
Aseptic Processing: Keeping it Safe
Manufacturers must understand how storage conditions affect permeation rates and design applicable stability programs.
Singh agrees that products manufactured using BFS have to be compatible with …
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Quality by Design and Extractable and Leachable Testing
These validated impurity tests are then added to the suite of tests run during the product stability study. Extracting, identifying, developing, and validating methods for these components is a costly…
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Technologies and Practices Must Evolve to Meet Demand
Respondents to the 2015 survey who develop or manufacture protein-based drugs expressed less concern about protein stability challenges than their counterparts did in 2014. Regulatory issues and micro…
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Challenges in Analytical Method Development and Validation
Alice Krumenaker, manager, QC Stability Administration, at West-Ward Pharmaceuticals, suggests that an analytical method may need to be modified and/or updated during the drug-development process to m…
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2014 Manufacturing Trends and Outlook
Protein stability led the list of reported technical challenges, cited by 53.7% of the respondents. Producing sufficiently high product yields was a close second at 52.2%; purifying high product yield…
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Protein L affinity resin is ready to move to manufacturing
The MabSelect™ VL protein L resin now offers improved alkaline stability compared to Capto™ L resin and a two-fold or more increase in dynamic binding capacity (DBC) in certain applications. After com…
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Assessing Manufacturing Process Robustness
The data collection plan and statistical methods to determine process stability and capability are adequate in identifying variability in the process to signal potential process improvements.
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The Evolving Role of Starting Materials in Cell and Gene Therapy
Similarly, shipping and storage logistics can introduce risk to these vulnerable products in the form of unforeseen delays or inadequate temperature regulation, which can affect product stability, aga…
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Best Practices for Selecting a Top-Quality Cell Line
Defining high-quality cell lines
A high-quality cell line will demonstrate high stability, scalability, and high titer, so that it can provide reproducible results—with all product quality attribu…