Search results for " patents"
Article
Improvements in Protein A Chromatography
Process Development Forum speaks about Protein A chromatography with Glen Bolton, Scientific Director at Amgen. Bolton recently published a paper “Role of more than 40 years of improvement in Protei…
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
For the earliest biologics, patents have expired or are near expiration, opening the door for follow-on generic product competitions. FDA approved the first Humira (adalimumab) biosimilar, Amjevita (A…
Article
Improving Process-Scale Chromatography
Advances in technology are increasing the productivity and efficiency of commercial-scale chromatography bioprocesses.
By Cynthia Challener, PhD
Chromatography is a crucial step in the purif…
Article
Perfusion in the 21st Century
Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.
By Bruce Lehr, Delia Lyons
Cell-culture technology for biopharmaceutical manufact…
Article
Biosimilars: Making the Switch Comes with Challenges
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.
By Sean Milmo
The use o…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design.
By Peter Genest, John Joseph
The benefits of adopting single-use technologies in the production of biopharmaceuticals…
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Continuous Processing for the Production of Biopharmaceuticals
The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platf…
Article
Finding Opportunities in Brazil
Feb 06, 2015
By Hellen Berger
BioPharm International
Volume 28, Issue 2
Brazil’s turbulent presidential election in October 2014 shed some light on the country’s political landscape …
Article
FDA Approves First Biosimilar
Mar 06, 2015
By Randi Hernandez
BioPharm International
FDA approved Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. The approval is a groundbreaking decision, as Sandoz is the firs…
Article
New Era for Generic Drugs
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.
Nov 1, 2014
By: Jill Wechsler
BioPharm International
Volume 11, Issue …