Search results for "Science" in Articles / App Notes
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Mark, Encyclopedia of Polymer Science and Technology (John Wiley, Hoboken, NJ, vol. 2, 2003), pp. 49
About the Authors
Sara Ullsten, PhD is bioprocess project manager; Eva Lindskog, PhD, is up…
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
Resin structure is a science in itself. Many resins use the same or similar ligands, but perform quite differently in use, such that manufacturers must balance a number of factors in order to optimize…
Article
New Era for Generic Drugs
…crance, then acting deputy director for generic drug chemistry in CDER’s Office of Pharmaceutical Science (OPS), at the FDA/PQRI conference in September 2014. The risk-based review approach has alrea…
Article
High-Throughput Process Development in an Historical Environment
Cornelia Walther from University of Natural Resources and Life Sciences in Vienna, Austria, presented work on refolding of inclusion bodies. Traditionally, optimization of the refolding steps has been…
Article
DoE Provides Benefits, but Preparation Is Necessary
LaBrenz, scientific director, pharmaceutical development and manufacturing sciences with Janssen Research & Development. At the same time, DoE results depend on the selected critical parameters and th…
Article
Application of Quality by Design to Viral Safety
QbD functions across the lifecycle of the product and integrates sound science with risk management. This approach uses the concepts laid out in the International Conference on Harmonisation of Techni…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability.
Sep 2, 2014
By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…
Article
Challenges of Protein Aggregation During Purification
Liddell, head of process sciences with Fujifilm Diosynth Biotechnologies.
“Aggregate formation is generally dependent on the solution conditions (conductivity and pH), protein concentration, and t…
Article
Concentration and Diafiltration of Cell-Derived, Live Influenza Virus Using 750 C Hollow Fiber Filter Cartridge
Cross flow filtration (CFF) is a technique extensively used in vaccine production and particularly in influenza vaccine manufacturing. In contrast to normal flow (dead-end) filtration (NFF), the fee…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Ultimately, a clear picture of attribute criticality, followed by mapping of their linkages to process parameters, can enable well-justified, science-based control strategies that put the right contro…