Search results for " stability" in Articles / App Notes
Article
Modeling and Miniaturization: Key Topics at Successful HTPD Conference
…or formulation using a Sartorius beta system, and also how static light scattering could be used for stability screening.
The final session of the conference “Frontiers in Process Development” wa…
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
There were many questions about dealing with variability in raw materials, evaluation of stability, and addressing unique supply chain issues.
Bryan Silvey, senior director for quality compli…
Article
Managing Risk in Raw Material Sourcing
The goal is a safe, robust formulation that will meet bioequivalence and stability requirements, but also enable validatable manufacturing, explained Chris Moreton, consultant with FinnBrit Consulting…
Article
Generating a Fully Processed Antibody
The authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.
B…
Article
Microbiological Testing: Time is of the Essence
For release of traditional biologics that are produced in large lots with longer stability profiles, the turnaround time on conventional microbiological tests, which are sensitive and robust, is not a…
Article
Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems.
By Jerold M. Martin
Single-use technologies (SUT) have made significant inroads in …
Article
Affinity chromatography Handbook: Vol. 2 Tagged Proteins
In some cases, tags may improve the stability and solubility of recombinant proteins.
Download the handbook
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Mallya, “Validation of Analytical Methods,” presentation at the Stability Conference of International Pharmaceutical Association of Canada (New Brunswick, NJ, May 2013).
22. N. Afonina, L. Bhattac…
Article
Resolving a bottleneck in screening and characterization of recombinant antibody fragments using Biacore 4000
Kinetic analysis at different temperatures provided additional information on the temperature stability of the selected fragments with respect to affinity. Chimeric chicken/human Fab fragments were sc…
Article
Platform Approach Speeds Process Development
Analysis of cell line stability and product quality is included to select the best-producing high-quality production clone.
The commonly used host cells for cell line generation are the FDA-accept…