Search results for " information" in Articles / App Notes
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
An assessment of mycoplasma contamination in the National Center for Biotechnology Information Sequence Read Archive conservatively found that 11% of projects were contaminated (19). The authors estim…
Article
Selecting a Comprehensive Bioburden Reduction Plan
Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination.
By Randi Hernandez
There are multiple variables to consider …
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
By studying multiple factors simultaneously, DoE allows a maximum amount of information from the minimum number of experiments. Objectives such as screening, optimization, and robustness testing are s…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
It aims at harmonizing inspection procedures globally by developing common GMP standards, training inspectors, and facilitating exchange of information and mutual confidence between regulators.
Article
ÄKTA Laboratory-Scale Chromatography Systems Handbook
Experienced system users will also find valuable and detailed information on different hardware modules.
Download now.
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
Biosimilars Will Bring Significant Litigation and Patent Challenges
…he litigation to date has stemmed from biosimilar applicants trying to avoid the BPCIA's complicated information exchange and negotiation processes, and attempting to side-step its requirements to di…
Article
Ensuring the Quality of Biologicals
This informational chapter, which is intended to be published by the end of 2015, has undergone public enquiry and gives examples of the critical quality attributes specific to each class of raw mater…
Article
Modular Manufacturing Platforms for Biologics
Thus, the company writes, a measure of both viable and nonviable particles is required to provide enough information about whether or not a cleanroom is suitable for a biologic (12).
The level of …
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 …