Search results for "host" in Articles / App Notes
Article
Biosimilars to Drive Modern Manufacturing Approaches
The manufacturer also has to carefully develop analytical methods and the expression system for the construct and host cell. These activities can help refine the manufacturing process, where incorpora…
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
It was decided with support from various regulatory agencies to make every effort to avoid sources that were known as potential hosts for human pathogens, such as bovine sources, and also to require s…
Article
A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
Complexity and scale are two stumbling blocks to the implementation of single-use systems on the commercial manufacturing scale, reported participants in a panel discussion hosted by BioPharm Internat…
Article
Implications of Cell Culture Conditions on Protein Glycosylation
The choice of host cell and the bioreactor conditions used in bioproduction of proteins significantly affects protein product quality. This is due both to the structural complexity of proteins themsel…
Article
Selecting the Right Viral Clearance Technology
Target clearance values also depend on whether certain viruses are known to be present in the host organism or if the process is intended to clear a broad range of virus types. “An inadequate understa…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
Editors’ Note: This article is based on a topic addressed during the 6th Pharmaceutical Inspection Co-operation Scheme (PIC/S) Expert Circle on APIs meeting, held in Rome in May 2014 and hosted by the…
Article
USP Stresses Pharmacopeial Standards at CPhI China
Jun 29, 2015
By BioPharm International Editors
The United States Pharmacopeial Convention (USP) hosted a pharmacopeial and regulatory compliance seminar at the 2015 CPhI China conference, he…
Article
Fermentation for the Future
The company also offers a modular plasmid system, platform host strains and a set of helper proteins designed to work with the platform. In addition, VTU can produce up to 25,000 clones per week in 96…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
The latter would include both assessment of the function of the drug in the serum, as well as the activity of potentially induced host neutralizing anti-drug antibodies (nAbs). “Very importantly, for …
Article
New Era for Generic Drugs
Hatch-Waxman also has generated a host of legal, regulatory, and economic issues that complicate generic drug oversight and distribution.
User fees alter landscape
The Hatch-Waxman anniversary a…