Search results for " characterization"
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The authors review efforts to limit polymer degradation without significantly impeding cell growth.
Jan 01, 2015
By Sara Ullsten, Shujian Yi, Jeffrey Carter, Eva Lindskog, Pokon Ganguli, Her…
Article
Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain.
Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technol…
Article
Improving PAT for Biologics
The recent emphasis on establishing a thorough understanding of the manufacturing process from the earliest process design stages through the use of process characterization studies is, however, a key…
Article
Viral Clearance Challenges in Bioprocessing
The Parenteral Drug Association Technical Report 47 (2) provides a framework for the preparation and characterization of virus preparations, and individual testing labs have developed their own descri…
Article
DoE Provides Benefits, but Preparation Is Necessary
For spectral data from characterization assays, Janssen calculates the Center of Spectral Mass Wavelength (or Mean Center Mass), which allows the creation of a relative stability profile for a given s…
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 and Trends in Biopharma Facility Design
Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design.
Sep 1, 2014
By: Susan Haigney
BioPharm International
Volu…
Article
Challenges of Protein Aggregation During Purification
Liddell adds that combining bioinformatics at the design stage with more extensive preformulation screens using high throughput approaches and additional characterization of aggregation propensity usi…
Article
Evaluating Design Margin, Edge of Failure and Process
Design space generation is encouraged in new product development.
Sep 1, 2014
By: Thomas A. Little, PhD
BioPharm International
Volume 27, Issue 9, pp. 46-49
A product’s or proc…
Article
Raw Material Variability
Fixing Variability in Raw Materials
Current best practice to fix these compliance issues includes extensive investigation and characterization of the impact, multifaceted statistical analysis (m…