Search results for " specification"

Article A Bright Future for the Plasma Fractionation Industry
The advantages of this QbD approach were claimed to be better information for process design, clear justification of the process and product specifications, and well-structured process and product kno…

Article Advanced Technologies Facilitate Scale-up and Technology Transfer
Single-use and modular technologies plus continuous manufacturing are increasingly important to biopharma scale-up and tech transfer. Jun 01, 2015 By Cynthia A. Challener BioPharm Inte…

Article Biosimilars Will Bring Significant Litigation and Patent Challenges
May 04, 2015 By Randi Hernandez  The risks involved with patent suits may become a bit more undesirable, thanks to new legislation aimed at deterring unreasonable patent suits. A senate bill…

Article Modular Manufacturing Platforms for Biologics
May 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 5 It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…

Article The Bullish Outlook for Biosimilars
Feb 01, 2015 By Jill E. Sackman, PhD, Michael J. Kuchenreuther, PhD BioPharm International There are several important reasons for stakeholders to be optimistic about prospects for b…

Article High-Throughput Process Development in an Historical Environment
Presentations, discussions, and information-sharing on modern bioprocess technology and high-throughput process development (HTPD) in an historical and culturally enriched environment is the essence…

Article DoE Provides Benefits, but Preparation Is Necessary
Nov 1, 2014 By: Cynthia Challener, PhD BioPharm International Volume 11, Issue 27, pp. 28-29  Using a design-of-experiment (DoE) approach allows a formulation development scientist t…

Article Bureaucratic Roadblocks Threaten Biopharma Growth
Protecting intellectual property rights is vital to biopharmaceutical innovation. There is a clear link between a country’s rate of economic development and the strength of its intellectual p…

Article Gowning Practices Provide Clues to cGMP Compliance
Review gowning practices as a tool to evaluate cGMP compliance in a facility. The foundation of any successful quality-assurance system is strict adherence to good manufacturing practices (GMP…

Article Raw Material Variability
Common examples would be out of specification for a product critical quality attribute (CQA), slower cell growth, low titer, and evidence of extraneous matter following visual inspection. Fixing…

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