Search results for " stability" in Articles / App Notes
Article
Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…
Article
Cell-Culture Advances Test Bioreactor Performance Models
…ents coming from cell-line traits such as gene promoter strength, gene integration site, integration stability, modified metabolic pathways, etc. Furthermore, aspects of bioprocess engineering have s…
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
On a therapeutic protein, the composition of these glycans can significantly impact the drug’s stability, pharmacokinetics, and biological activity. Thus, glycan structure is a critical quality attrib…
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
The stability of aseptically filled drugs will be affected by a variety of factors. Because aseptic filling requires close coordination and involves complex interaction between personnel, sterilized p…
Article
Putting Viral Clearance Capabilities to the Test
…s and end-of-production cells are tested to identify species of origin, confirm expression construct stability, and to demonstrate the absence of potential bacterial and viral contamination. “Additio…
Article
Leveraging Data for Better Biopharmaceutical Process Control
Leveraging Data for Better Biopharmaceutical Process Control
The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and dow…
Article
Modern Manufacturing Key to More Effective Vaccines
Test vaccines also may be used prior to obtaining real-time stability data, especially for early clinical trials.
An accelerated pathway for vaccine testing, however, “puts the squeeze on the …
Article
Transformative Medicines Challenge FDA and Manufacturers
…ia, to re-examine impurity acceptance criteria based on data from commercial batches, and to conduct stability testing on drug product process validation batches. The company also may find it appropr…
Article
ADC Development Robust Despite Lackluster Performance
…pensate for the payload’s poor solubility, thus minimizing aggregation and maintaining the ADC’s stability while in circulation (13). Multiple molecules of this polymer-payload construction (Dolaflex…
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…