Search results for " standardization"
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
ASN-0002: Authentication of Human Cell Lines: Standardization of STR Profiling, ATCC-Standards Development Organization (SDO), Manassas, Virginia, USA (2012).
22. F. Castro et al., Int. J. Can…
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexa…
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
Ensuring the Quality of Biologicals
BRPs are established in view of achieving standardization of test methods for the quality control of biologicals. Collaborative studies are undertaken to establish these reference preparations leading…
Article
Securing the Single-Use Supply Chain
Parkinson, on the other hand, argues that standardization would lead to a halt in innovation. “Single-use products are not commodities and will not be in the foreseeable future; innovation is critical…
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
Ensuring buildings, whether stick built or modular, comply with international standards, such as Deutsches Institut für Normung (DIN), European Standards, International Organization for Standardizatio…
Article
Establishing Acceptance Criteria for Analytical Methods
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.
By Thomas A. Little, PhD
To control the consistency and quality o…
Article
Modular Manufacturing Platforms for Biologics
While modularity supports standardization and repeatability, it can also support customization if done correctly, says Almhem. “Taking a fixed process and installing it in a building module does not p…
Article
Global Expansion Shapes Drug Oversight
Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.
Few FDA officials discuss pharmaceutical regulation these days without …