By Anna Rose Welch, editor, Biosimilar Development
It’s only natural to expect animated scientific discussion between the FDA and USP, which have long been partners in science. But I was caught off guard by just how firmly the FDA has been putting its foot down on the role certain USP standards should (or should not play) in biologics development.
By Tobias Kuners of Koenders, managing consultant, Tob Management
Part 1 of this two-part series looked at the core aspects of Maintenance 4.0 and outlined a comprehensive maintenance process flow. In this second part, we will discuss how to get started with Maintenance 4.0, along with how to develop benchmark metrics that allow assessment of the gap between the current and desired states.
Application Note |
By J. Greenwood II, et.al.,Bio-Rad Laboratories, Inc.
The large size of IgMs makes their purification very challenging. See how Bio-Rad's new strong anion exchange resin (AEX), Nuvia HP-Q, has the ability to overcome the multiple issues faced when purifying large biomolecules.
When CDMOs understand what motivates drug innovators to outsource, who is involved in the service provider selection decision, and which CDMO attributes have the greatest influence on CDMO selection, they are able to communicate what is unique about their offering to the right audience at the right time.