Newsletter | August 28, 2019

08.28.19 -- Inside NIIMBL And Its New FDA Partnership

 
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Featured Editorial
Inside NIIMBL And Its New FDA Partnership
 
By Matthew Pillar, editor, BioProcess Online

NIIMBL director Kelvin Lee, Ph.D., gives us an exclusive update on the Institute and its goals, how it’s funded, who’s keeping score on progress, and what its newly expanded partnership with the FDA brings to the table.

2 Bills, 1 Goal: Lower Drug Prices Through Biosimilars
By Ronald W. Lanton III

Just prior to an election season, it is not surprising to see a few bills emerge as potential silver bullets to solve pressing policy issues. One issue that has consumed the public for several years is drug prices. This article examines two Congressional bills aimed at increasing biosimilar utilization in an effort to lower drug costs.

Industry Insights
How To Adapt Existing Biomanufacturing Processes To Maximize Production
Article | By Patrick Guertin and Yasser Kehail, GE Healthcare Life Sciences

Achieving “smarter,” more flexible workflows requires a complete understanding of today’s novel solutions and technologies, which, when applied appropriately, can push the boundaries of drug development and offer critical advantages in an increasingly competitive industry.

A Case Study In Real-Time Release Testing
Case Study | By Juan L. Torres, Ph.D., Biogen

Real-time release testing can be defined as a set of in-process controls that may provide greater assurance of product quality than end-product testing.

Single-Use Technology: The Next 5 Challenges To Conquer
Article | Parker Bioscience

While single-use processing has limitations with scale of operations when compared to stainless-steel setups, several trends are mitigating the impact of these limitations significantly.

The Use Of Amsphere A3 Resin To Purify Antibody Fragments
Q&A | JSR Life Sciences

This Q&A outlines the use of Amsphere A3 resin to purify antibody fragments, explains the molecular binding mechanism for VHH single-domain antibodies, and compares dynamic binding capacity data with those of other affinity resins.

In Vivo Models And In Vitro Assays For Human RSV Infection: Preclinical Antibody, Small Molecule, And Vaccine Development
White Paper | GVK Biosciences

Despite over 50 years of research, there remains no licensed vaccine product, and disease due to RSV infection remains an unmet medical need. Learn how customized and high-quality preclinical animal models and ex vivo readouts can support your anti-RSV biologics development from concept all the way to IND.

Optimize Biologic Drug Development With The Power Of Scientific Informatics
Webinar | Dassault Systemes Americas
The complex structure of biologics, and the nature of the interactions with their partners, requires accurate modeling methods to predict their physicochemical properties.
Mitigating Risk Through Product Characterization
Webinar | MilliporeSigma (Product Characterization)

In this webinar, multiple approaches to characterizing the physicochemical and structural attributes of therapeutic mAbs is presented, with a focus on how it influences the resulting biological activity.

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