Search results for " variability" in Articles / App Notes
Article
Best Practices for Selecting a Top-Quality Cell Line
Challenges with variability, complexity, and regulations
Selecting the optimum cell line must occur in the face of several challenges. For Fisch, the biggest hurdle to overcome is the varia…
Article
Cell-Culture Advances Test Bioreactor Performance Models
Mistretta agrees that variability of single-use systems does impact cell culture, but Amgen has been able to rapidly detect and determine the root cause for this cell culture variation through the acc…
Article
Leveraging Computational Models of Glycosylation for Biopharma QA
Biopharmaceutical glycosylation variability is determined by manufacturing bioprocess conditions (1). Large-scale mammalian cell culture is used for the manufacture of all therapeutic glycoproteins (T…
Article
Nurturing Knowledge from Disparate Data Streams
Because biologic drug substances are produced in cells or microorganisms, their structures and compositions can vary slightly from batch to batch, leading to inherent variability, according to Tiffani…
Article
QbD Improves Cell-Culture Process Control
Even in a bioprocess with identical process settings, however, variability in end-product quality output is still likely to occur due to the variability of inputs, such as the raw materials and the li…
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
Bioburden Control in the Biopharmaceutical Industry
Protecting against microbiological contamination over the whole manufacturing process grows increasingly important.
By Mostafa Eissa
The biopharmaceutical industry has witn…
Article
Best Practices for Data Integrity
How might we leverage that data to minimize variability?’
At a large contract manufacturer in Salt Lake City, Utah, for example, one quality manager took it upon her team to try and ident…
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
The basic requirement for a good model is for it to be predictive and be able to explain at least most of the variability in the data. In addition, the model should be feasible for implementation in a…
Article
Antibody Production in Microbial Hosts
The authors review the status of expression of antibodies in microbial hosts and present the recent advances in the production of aglycosylated antibodies in bacteria.
By Anurag S. Rathore, Jyot…