Newsletter | March 19, 2020

03.19.20 -- How Can Hospitals Lead The Biosimilar Charge?

Featured Editorial
How Can Hospitals Lead The Biosimilar Charge?
By Anna Rose Welch, editor, Biosimilar Development

One oncology expert shares his thoughts on the operational challenges biosimilars may pose hospitals and what biosimilar manufacturers need to consider as they continue to invest in and launch oncology biosimilars.

Bracing For March 23: FDA Issues Final Q&A On Transition Biologics
By Kate Cook, Greenleaf Health

The FDA has prepared diligently for the transition date by issuing guidances addressing several sticky issues, including final Q&A guidance on the "deemed to be a license" provision of the BPCIA.

U.S. Sites Play Surprise Role In FDA’s Drug GMP Warning Letter Report
By Barbara Unger, Unger Consulting Inc.

Fiscal year 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, depth of focus, and trends in enforcement actions. This article presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.

Industry Insights
Biosimilars Made Simple: A Micro-Analysis Of Biosimilars & Relevant Policy
White Paper | By Lanton Law

With all the promise biosimilars hold, why we are not seeing increased market uptake? There are many reasons that involve policy, legislation, and the legal system that have led to the current state of the biosimilar market in the U.S. This white paper examines the basics.

The Benefits Of Flow Cytometry In Immuno-Oncology Research
Article | By Jennifer Ellis and Gunjan Choudhary, Bio-Rad Laboratories, Inc.

Flow cytometry introduces a powerful and versatile technology into studies, enabling in-depth analysis of cell signaling and behavior.

Purifying Tagged Proteins Using ÄKTA go Protein Purification System
Application Note | GE Healthcare Life Sciences

ÄKTA go is a small and compact liquid chromatography system that allows researchers to perform routine protein purification with ease while allowing for efficient use of bench and cold cabinet space.

Sterile Injectables Fill/Finish
Pfizer CentreOne Contract Manufacturing
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