Search results for " characterization" in Articles / App Notes
Article
Developing a Robust Bioprocess Using Mechanistic Models
Regulatory agencies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA) demand strict requirements on process characterization and validation studies and ask for a deep …
Article
Using Digital Twins to Model Process Chromatography
Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.
By Jennifer Markarian
A digital twin is a model of a proces…
Article
Purifying Samples for Cryo-EM Preps
Join us to learn about:
- Managing purification in microliter scale
- Sample characterization in cryo-EM workflows
- Tools and tips for purifying samples for cryo-EM
Date: Tuesday, Oct…
Article
Controlling Cell Culture Process Variability Through Supplier-Enabled Data Management and Analytics
In drug development and manufacturing, variability in raw materials presents high risks to the success of processes and products. When raw material variability issues arise, manufacturers and supplier…
Article
Best Practices for Selecting a Top-Quality Cell Line
Irina Shi - Stock.Adobe.com
Leveraging automation and a step-by-step approach are keys to success.
By Cynthia A. Challener
Cell lines determine the performanc…
Article
Monitoring and Control of Inline Dilution Processes
Another important factor for consideration, according to Vermunt, is the fact that for many buffers, creating a concentrate suitable for ILD is equal to the study and characterization needed for use-s…
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
What’s more, analytical platforms for in-process control and cell characterization are lacking in the cell therapy industry but are being actively pursued.”
It is important to note, however, whe…
Article
Moving PAT from Concept to Reality
Raw-material characterization is performed using handheld Raman/near infrared (NIR) scanners. In bioreactors, in-line sensors measure pH, temperature, dissolved oxygen (DO), and carbon dioxide; in-lin…
Article
Emerging Therapies Test Existing Bioanalytical Methods
The time upfront in production and characterization of high-quality reagents will result in reduced cost and timelines for the program. Experiments to develop the methods should be carefully thought t…
Article
Scalable Viral Vector Manufacturing
The interest for robust and scalable viral vector manufacturing is rapidly increasing, with the recent developments of both cell and gene therapy and oncolytic virus-based therapies. As cost pressur…