Search results for "analysis" in Articles / App Notes
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 expe…
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
…armaceuticals, they are increasingly required to shift focus to large-molecule characterization and analysis with the growth of biotherapeutics in the pharmaceutical industry pipleline (2).
…
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…
Article
Development of Purification for Challenging Fc-Fusion Proteins
Data analysis
Statistical analysis was carried out using Minitab software. Percent reduction was defined through the use of Equation 1:
[Eq. 1]
…
Article
Managing Risk in Raw Material Sourcing
To identify and assess risk, the company uses a documented risk-assessment process, facility audits, and a toolkit that includes such methods as failure modes and effect analysis, fishbone diagrams, a…