Newsletter | February 25, 2021

02.25.21 -- The Opportunities & Challenges Of India's Biologics Market
 
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Featured Editorial
The Opportunities And Challenges Of India’s Biologics Market
 
By Joseph Pategou

Biosimilar drugs, due to their affordability, can play an important role in allowing the Indian government to provide a better healthcare system. However, as issues remain on the regulatory and manufacturing sides, India needs to see strong improvements to compete and appear as an important hub nationally and internationally.
The Intriguing FDA News You May Have Missed
 
By Anna Rose Welch, chief editor, Biosimilar Development

The Biosimilars Forum announced via press release that it had submitted commentary to the FDA’s notice entitled, “Examination of Secondary Claim Disclosure and Biosimilar Disclosures in Prescription Drug Promotional Materials.” Here’s what you should know about the FDA’s latest notice.
Industry Insights
Don’t Let Insufficient Data Undermine Your CMO And CRO Selection Processes
Article | By Kevin Olson, ISR Reports

Selecting a partner is challenging, but, with the right information, you can simplify your efforts and increase your likelihood of making the best decision. 
Manufacturing Of Sterile Aqueous Suspensions: A Primer
White Paper | By Omar A. Salman, Ph.D., Pfizer CentreOne Contract Manufacturing

Sterile suspensions are particularly difficult to manufacture. This technical article covers factors for success, including particle size, vehicle formulation, and considerations for high-shear mixing. 
Converting From ELISA To Biacore SPR Assays
Application Note | Cytiva

This article provides general guidance on how to convert an existing ELISA assay to a Biacore SPR assay and, by doing so, shows how you can get results in less than half the time compared with ELISA.
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