Newsletter | August 1, 2019

08.01.19 -- FDA & USP Clash On Biologics Standards

Featured Editorial
The Debate On Standards In Biologics Development Heats Up
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.

Bio/Pharma Maintenance 4.0: How To Get Started
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.

Industry Insights
Industry 4.0: Embracing Digital Transformation In Bioprocessing
Article | By Per Lidén, GE Healthcare Life Sciences

Currently, there is a transformation taking place that will pave the way for even more changes to how the industry approaches drug manufacturing.

Purification Of An Acidic IgM For Large Biomolecule Purification
Application Note | By J. Greenwood II,, 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.

Standing Out In The Crowded Biopharma CDMO Market
Webinar | ISR Reports

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. 

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