Search results for " specification" in Articles / App Notes
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
By Leonard P. Freedman, Mark C. Gibson, Richard M. Neve
Irreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays and increased costs of …
Article
Fluid Handling in Biopharma Facilities
Industry experts discuss challenges, trends, and innovations in fluid handling.
By Susan Haigney
Contamination prevention in biopharmaceutical manufacturing is crucial, and the proper handling…
Article
Using Single-Use Technologies in Downstream Processing
The use of single-use systems in downstream processing offers benefits in filtration and sampling and may reduce the risk of contamination.
Jul 01, 2015
By Susan Haigney
BioPharm Inter…
Article
Taking a “Development-by-Design” Approach to Cell Therapies
The two companies have already been working together for a year now, honing the design and specifications for the instrumentation, says NeoStem’s Chief Scientific Officer (CSO) Robert Preti. The equip…
Article
Use of Multivariate Data Analysis in Bioprocessing
Apr 06, 2015
By Anurag S. Rathore, Sumit K. Singh
BioPharm International
The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motiva…
Article
Continuous Chromatography: Trends, Definitions and Approaches
Process Development Forum speaks with Karol Lacki, Customer Collaborations Leader at Cytiva, about continuous chromatography.
There is a lot of attention being paid to continuous chromat…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
Apr 02, 2015
By Jill Wechsler
Pharmaceutical Technology
Volume 39, Issue 4
To ensure patient access to high quality, safe, and effective medicines, FDA spends considerable time and resou…
Article
Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 4
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …
Article
Quality by Design and Extractable and Leachable Testing
What are the planned sets of controls, based on the design space that will ensure end-product quality? It is sensible to apply control upstream--to the component extractable specification--where the s…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
This finding can be used by SUS suppliers in raw material specifications to ensure consistent product performance in bioprocessing end use. There is no universal threshold value, however, for oxidized…