Search results for " analysis"
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
“In addition,” he says, “use of analysis of the data collected by the manufacturing execution system can provide information about trends during different changeovers and their possible impacts on the…
Article
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Recently, the BioPhorum Operations Group (BPOG) conducted an economic analysis of the use of liquid handling systems and buffer concentrates (1, 5). The report highlights operational savings from usin…
Article
Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
IoT enabled devices can provide automated preventive maintenance and just in time (JIT) delivery of reagents, automated data collection, and analysis, and better integration with control systems, such…
Article
The Need for Advanced Process Modeling for New Therapeutic Biologics
… techniques that can be broken into several areas:
-Design of experiments and statistical analysis
-Deterministic models for optimization
-Scale-up models linked to exp…
Article
Ion Exchange Chromatography: Introducing New Capto™ HiRes Columns
• Designed for the preparation of highly pure proteins and for protein analysis, such as analysis of mAb charge variants.
• Replacing the well-established Mono Q™ and Mono S™ columns—with transiti…
Article
Emerging Therapies Test Existing Bioanalytical Methods
… well as recommended strategies for development, validation, and implementation of assays for sample analysis from regulated non-clinical and clinical studies.
Cellular and gene therapies are not…
Article
An Analytical Approach to Biosimilar Drug Development
Although analytical scientists have long been immersed in the traditional field of small-molecule pharmaceuticals, they are increasingly required to shift focus to large-molecule characterization and …
Article
Supply Chain Challenges for Single-Use Systems
Cytiva published a peer-reviewed single-use system lifecycle analysis (4). The results of this analysis showed that single-use consumables provide a better choice from the environmental impact perspec…
Article
Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
The annual report has expanded to include 60 questions with nearly 500 pages of analysis and data (1,2). Manufacturing capacity issues have always been at the core of the annual survey, but as the ind…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
The advantages of rinse sampling are that the entire surface can be sampled, with no disassembly of equipment and no direct sampling of the surface, and that rinse sample analysis via conductivity, TO…