Search results for " biotechnology"
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…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability.
Sep 2, 2014
By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…
Article
Healthcare Reform in China
The biotechnology sector is another key development that companies can look to explore. The Chinese government has invested $1.6 billion to support major new drug innovations from 2011 to 2015, focusi…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
The gene functions were obtained from the website of the National Center for Biotechnology Information (www.ncbi.nlm.nih.gov/gene).
Results
Concentrated feed medium M1 test in shake flask…
Article
Q&As with Industry Leaders
Karol Lacki, Customer Collaborations Leader, Cytiva
The Role of HIC in Biotech
Professor Alois Jungbauer, Department of Biotechnol…