Search results for " production" in Articles / App Notes
Article
Biosimilars Will Bring Significant Litigation and Patent Challenges
May 04, 2015
By Randi Hernandez
The risks involved with patent suits may become a bit more undesirable, thanks to new legislation aimed at deterring unreasonable patent suits. A senate bill…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
During biosimilar development, it is necessary to demonstrate that the physicochemical properties, efficacy, and safety (e.g., immunogenicity) of the biosimilar are similar to those of the …
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
Q&A with Industry Leaders: Rita Peters
Continuous processing is established in solid-dose manufacturing and is being used in upstream biopharmaceutical production. Strategies to connect upstream and downstream operations and extend continu…
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
Countries around the world face a gro…
Article
Innovative Chromatography Resins Can Improve Purity and Quality
In partnership, Navigo and Repligen completed ligand discovery, ligand selection, small-scale production, and scaled-up manufacturing in 10 months. In February of 2021, Repligen launched a new resin (…
Article
Cytiva Invests $500 Million Over 5 Years to Expand Global Capacity
Cell culture media production will increase as the result of new manufacturing lines, cleanroom space, personnel, and additional personnel shifts at the company’s site in Logan, UT. Further, the compa…
Article
Understanding Validation and Technical Transfer, Part 2
The obvious analogy is a clinical trial followed by subsequent commercial-scale production of a biopharmaceutical product.
The process inputs are water and coffee; but what type of coffee is se…
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
… BioPlan Associates’ 14th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (2).
The advancement of automation, including robotics, is one area of progress for f…
Article
Techniques for Improving Process Development for Exosome-Derived Therapeutics
Specifically, Codiak is investigating the delivery of nucleic acids and engineering exosomes that, when combined with a platform production process, can become exosome drug therapeutics that are scala…