Search results for "supplements"
Article
Eliminating Residual Impurities Starts with a Strategic Plan
Eliminating Residual Impurities Starts with a Strategic Plan
Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.
By Cynthia A. Ch…
Article
The Importance of Partnering for Bioanalytical Studies
The Importance of Partnering for Bioanalytical Studies
Yakobchuk Olena/Stock.Adobe.com
Bioanalytical studies are an important aspect of biologic drug development that may necessitate…
Article
Upstream PD Time-Saver: Optimize Early
Identify the right combination of culture medium, feed supplements, and feeding strategy early in upstream process development to conserve precious time and resources.
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
Achieving Process Balance with Perfusion Bioreactors
For new processes, for instance, an extra perfusion port or feed line for additional media supplements can be easily added.
In addition, the ability to assure sterility and no introduction of cont…
Article
Scalable Viral Vector Manufacturing
Also, the cell culture medium and any supplements need to be of clinical grade quality. From a regulatory perspective, it is recommended to avoid any raw materials that are of animal origin such as se…
Article
Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…
Article
Modern Manufacturing Key to More Effective Vaccines
Krause emphasized how FDA strives to review and approve submissions and manufacturing supplements in a “sensible” way that emphasizes good science. CBER also encourages manufacturers to meet with FDA …
Article
Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
By Adeline Siew, PhD
CA-SSIS/shutterstock.comIm…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach
Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling.
By Elizabeth Rivera…