Search results for " methods" in Articles / App Notes
Article
Using Software in Process Validation
Software systems have become instrumental as validation expands from analytical methods used for the quality control of drug substances and drug products to computerized systems for clinical trials, l…
Article
Cell-Culture Advances Test Bioreactor Performance Models
The evolution of cell-culture technology is driving the need for improvements in modeling solutions.
By Cynthia A. Challener
Modeling and simulation are recognized to provide assistance i…
Article
Tools and Processes for Mature and Emerging Therapies
The likelihood that manufacturing gene therapies or cell therapies in a cost-effective manner using current manufacturing methods is very unlikely.
Speakers at the BIO International convention in …
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Sephadex™ Size Exclusion Resin Turns 60
Do you know the story behind Sephadex, which enabled today's large-scale production of biopharmaceuticals? An inadvertent discovery in 1959 became the foundation for today's biopharma industry. This i…
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Single-Use for Downstream Chromatography: Benefit or Hindrance?
Thus, good sanitation methods and familiarity with the most likely microbial contaminant species present in the immediate environment are needed to address bioburden. Using pre-sanitized single-use co…
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Western Blot Detection: Is Film or a Digital CCD Imager Better?
It is based on building an antibody:protein complex via specific binding of antibodies to proteins immobilized on a membrane and detecting the bound antibody with one of several detection methods.
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Leveraging Computational Models of Glycosylation for Biopharma QA
…ions), flux models must be solved using constraint-based linear programming (29,30) or probabilistic methods, such as Markov chain Monte Carlo simulations (31,32). A key advantage of flux-based model…
Article
Advances in Engineering of Protein-Based APIs
Advances in Engineering of Protein-Based APIs
New platform technologies, advanced modeling tools, and addressing patient needs are important developments.
By Cynthia A. Challener
…
Article
Ensure SEC Column Reproducibility in Protein Drug Analysis
Size exclusion chromatography (SEC) is the go-to analytical method in the analysis of therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you…
Article
State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
Despite diverse genetic-engineering methods and host organisms being available, industry has clearly come to prefer and standardize on use of mammalian systems, particularly CHO. Many more efficient o…