Search results for " development" in Articles / App Notes
Article
USP Stresses Pharmacopeial Standards at CPhI China
“We will strengthen our collaboration with the Chinese Pharmacopoeia Commission and other partners to share knowledge on pharmacopeial standards, promote industry developments, and improve public heal…
Article
What’s In a Name? For Biosimilars, A Lot
Jun 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 6
There is still some uncertainty surrounding whether a biosimilar will share the same compendial identity—or …
Article
Biosimilars Will Bring Significant Litigation and Patent Challenges
…n processes, and attempting to side-step its requirements to disclose confidential manufacturing and development processes.”
Future litigation is expected to focus on the manufacturing processes …
Article
Re-use of Protein A Resin: Fouling and Economics
Maximizing the lifespan of preparative Protein A columns is a central topic during process development for monoclonal antibodies and Fc fusion proteins. It is clear that the industry does not have a d…
Article
FDA Approves First Biosimilar
Christl said in January 2015 that a major drug development concern with biosimilars is addressing analytical differences. She said that some biopharma companies fail to establish a strong foundation o…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The authors review efforts to limit polymer degradation without significantly impeding cell growth.
Jan 01, 2015
By Sara Ullsten, Shujian Yi, Jeffrey Carter, Eva Lindskog, Pokon Ganguli, Her…
Article
Trends in Single-use Bioreactors
Once those things are done for the first single-use unit operation, further development of similar strategies for additional single-use unit operations can occur.
Sherman (Sartorius): A single-use…
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
Applying GMPs to the BioPharma Supply Chain
Defining best biopharmaceutical practices is necessary to ensure the safety of the supply chain.
Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be availab…
Article
Biopharma Moves to Integrated, Single-Use, Downstream Processing
…ing processes currently used for downstream manufacturing to more continuous approaches requires the development of revolutionary technologies, such as continuous chromatography systems. On the small…