Search results for " biotechnology" in Articles / App Notes
Article
Quality Systems Key to Lifecycle Drug Management
Post-approval changes for biotech therapies will continue to be managed by OPQ’s Office of Biotechnology Products.
A smooth hand-off from new drugs to lifecycle is important, commented ONDP acti…
Article
Host-Cell Protein Measurement and Control
Jun 01, 2015
By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem
BioPharm International
Volume 28, Issue 6, pg 32–38
Host-cell proteins (HCPs) constitute a major part of proce…
Article
A Bright Future for the Plasma Fractionation Industry
That was one of the conclusions reached when the 9th Plasma Product Biotechnology (PPB) meeting ended on the beautiful island of Sardinia, Italy in mid-May. This meeting series, which is a joint organ…
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
Ensuring the Quality of Biologicals
This was followed by monographs for an increasing number of biotechnology products in the 1990s and 2000s. As the Ph. Eur. moved into the 21st Century, it increased its activity in the biological fiel…
Article
Labeling of Biosimilars
“As a result there are some countries where intended ‘copy’ (or non-comparable) biotechnology products have been licensed under regulatory pathways that are not appropriate for biotherapeutic medicine…
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
Improving PAT for Biologics
According to Becker, as biotechnology has advanced, the number of factors and setpoint accuracy and precision of control have become more demanding. At the same time, regulatory agencies have continue…
Article
Viral Clearance Challenges in Bioprocessing
Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin (1998).
2. Parenteral Drug Association, Technical Report No. 47: Preparation of Virus…
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…