Newsletter | July 3, 2019

07.03.19 -- Is FDA Preparing For Tailored Biosimilar Development?

 
Featured Editorial
FDA’s “Show Me The Data” A Recipe For Tailored Biosimilar Development?
 
By Anna Rose Welch, editor, Biosimilar Development

In this first of what will be a two-part article, USP's Fouad Atouf highlights the challenges presented by the FDA’s newest guidance while remaining optimistic that the large amount of data recommended today will open doors to more efficient development in the (hopefully) near future.

Trends In Single-Use System Adoption In The Biopharma Industry
 
By Ilene Roizman, BioPlan Associates, Inc.

Upstream bioprocessing at large and commercial scales is projected to be the fastest growing segment of the single-use system (SUS) market as products now in development using SUSs move up to commercial manufacturing.

Industry Insights
Addressing New Chromatography Challenges With Fiber Adsorbents
White Paper | By Iwan Roberts, GE Healthcare Life Sciences

A new adsorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed-bed chromatography purification systems and also aims to address the capacity issues of chromatography membranes.

Stop Compromising Between High Yield And High Purity In Downstream Purifications
Application Note | Bio-Rad Laboratories, Inc.

Mixed-mode resins are often used when unimodal resins fall short of providing the required process productivity and/or process economics. To overcome this deficiency, Bio-Rad developed the Nuvia aPrime 4A Resin with an optimal balance of ion exchange and hydrophobic interactions to deliver simultaneous purity and yield of therapeutic proteins and monoclonal antibodies that are typically difficult to purify.

Services Marketing: You Can’t Build A Strong Marketing Strategy On A Weak Foundation
Article | By Kevin Olson, Industry Standard Research

Too often, marketers lack vital information to create an effective marketing strategy and your organization and department suffer due to constant disruptions of marketing plans. 

Sponsor
 

Join Biosimilar Development in attending the global 10th annual SMi Biosimilars Conference, held September 25 and 26, in London, United Kingdom. The meeting will gather biosimilars experts to discuss manufacturing and commercialization. Hear from key opinion leaders as they offer insight into the areas of sustainability of the biosimilars market, understanding the regulatory framework, overcoming legal issues, and bridging the gap between pharmaceutical companies, patients, and investors. Registration is now open — register here now.

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