Newsletter | November 18, 2021

11.18.21 -- Updated Orange Book/Biologic Patent Study: Key Learnings

 
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Capitalize On Merger/Acquisition: 4 Tips To Consolidate Your CMO Network

Complex CMO networks are expensive and require many resources to manage. Plus, they prevent purchasing and operating at scale. Yet, the process of consolidating CMOs is daunting.

How To Use Quality By Design (QbD) Software To Improve An Existing Identification Method

What can you do when the identification method defined by the USP monograph does not provide clear guidance? The authors decided to improve the method with a quality by design (QbD) approach.

Optimizing Drug Safety And Efficacy Of Complex Next-Generation Biologics

Challenges exist when developing biologics drugs to be efficacious but safe. Novel analytical techniques, such as surface plasmon resonance, can help circumvent these issues and optimize development.

Increasing Productivity In Hydrophobic Interaction Chromatography (HIC)

In this study, the hydrophobicities of newer generation Capto HIC resins were compared to Sepharose High Performance and Sepharose Fast Flow HIC resins.

Measuring Interactions Between Fc Regions Of mAbs And Fc Receptors
It is crucial to evaluate the binding interaction of monoclonal antibodies (mAbs) with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo.
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