Search results for " activity" in Articles / App Notes
Article
Ensuring the Quality of Biologicals
moved into the 21st Century, it increased its activity in the biological field to address increasing numbers of biologicals and challenges driven by development of biosimilar products.
Pharmacopei…
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
Drug Discovery and Development in India
Apr 01, 2015
By Jane Wan
BioPharm International
Volume 28, Issue 4
Indian pharmaceutical companies’ entry into the drug discovery and development field dates back to the early 1990s …
Article
USP Publishes Monoclonal Antibody Guidelines
Mar 02, 2015
By Dale Schmidt, M.S., Anita Y. Szajek, PhD, Fouad Atouf, PhD, Tina S. Morris, PhD
BioPharm International
Volume 3, Issue 28
As FDA gears up towards approving biosimilar dru…
Article
SEC in the Modern Downstream Purification Process
Another benefit of using SEC is that the biological activity of the target of interest is preserved throughout the separation process, particularly if the target of interest requires that its quaterna…
Article
Relationship Building at Top of Mind for Clients
Annual study shows technical expertise is not enough.
Aug 1, 2014
By: Eric Langer
BioPharm International
Volume 27, Issue 8, pp. 12-14
Contract manufacturing organizations (CMOs) shou…
Article
Single-Use and Continuous Processing Technologies Change Facility Design
Viewing Changes in Pharmaceutical Facility Design
Single-use systems, continuous processing and isolator technology use a smaller footprint. Experts predict how the facilities of the future may …
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 …
Article
Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …
Article
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
“For structurally more simple biological medicinal products, a comparative clinical efficacy study may not be necessary if similarity of physicochemical characteristics and biological activity or pote…