Search results for " stability"
Article
Handbook: Design of Experiments in Protein Production and Purification
…uitable experimental conditions, for example, for cell culture, protein separation, study of protein stability, optimization of a process, or robustness testing. This handbook provides an introductio…
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…
Poster
A Next Generation Protein A Chromatography Resin for Improved Productivity and Bioburden Control
This poster presents a newly designed, high-capacity Protein A resin, MabSelect™ PrismA, which offers alkali stability on par with ion exchange and hydrophobic interaction chromatography resins, enabl…
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…
Poster
Guide to modern BioProcess™ chromatography resins
Proteins are different. Based on what protein you would like to purify and the conditions used, chromatography resins are selected to optimize purity and yield. Many bioprocess applications include …
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.
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