Search results for " quality"
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
…n to reduce testing during cleaning qualification and continuous monitoring stages without impacting quality. Laboratory results from total organic carbon (TOC) and conductivity rinse sample for an a…
Article
Perfusion in the 21st Century
Now, improved continuous culture technologies such as perfusion are on the rise, as biosimilar manufacturers look for new ways to cut costs while increasing quality and productivity.
With perfusio…
Article
Framing Biopharma Success in 2016
Encouraging companies to make capital improvements to avoid future quality and manufacturing problems, however, can be a tough financial and regulatory argument. In a 2015 survey of 100 executives fro…
Article
Implications of Cell Culture Conditions on Protein Glycosylation
Richard Easton
This article reviews the implications of cell-culture conditions on biologic product quality, focusing on glycosylation and analytical techniques for its accurate assessment. Glyco…
Article
Tackling Analytical Method Development for ADCs
Both small and large
As for any drug, analytical methods for the characterization of ADCs must be developed, and separate quality control (QC) tests must be established for lot release of the fina…
Article
Improving PAT for Biologics
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) approach to pharmaceutical manufacturing is the implementation of process ana…
Article
Setting Standards for Biotech Therapeutics in India
India has emerged as a key supplier of high quality and affordable medicines not only to the developing world, but also to developed economies as well (Figure 1A) (1). This sector has recorded a compo…
Article
EMA Collaborates with HTA Assessment Networks
First a drug has to be approved for its quality, safety, and efficacy by one or more regulatory authorities. This approval can be either by the central London-based European Medicines Agency (EMA) for…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Before an analytical method can be incorporated into a characterization platform or a quality control system, it must first demonstrate that the method is suitable for its intended purpose. Guidelines…
Article
Remote Monitoring and Big Data Advance Upstream Automation
“Connected, continuous, and process analytical technology (PAT) solutions that bring more process intelligence and quality decisions to the factory floor are becoming more common,” asserts Marc Sincla…