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  Bioprocessing Market Trends And Outsourcing Dynamics
 

This report affords readers the opportunity to gain insight into the bioprocessing market and where it’s heading. It provides an overview of the current market dynamics for bioprocessing as well as an outlook on what our survey respondents predict the marketplace will look like in five years. You can purchase the full report or download a free preview by clicking here.

Featured Editorial
4 Takeaways From The FDA’s Insulin Hearing
 
By Anna Rose Welch, editor, Biosimilar Development

Overall, four talking points arose during the presentations that were worthy of singling out. Many of these points touch on the broader discussions happening in the biosimilar sphere, including tailored development, interchangeability, immunogenicity, device innovation, and overall patient and provider education.

HHS Safe Harbor Rebate Proposal: Biosimilars' New Hope?
 
By Ronald W. Lanton III, Frier Levitt Government Affairs, LLC

This proposed rule would end the “safe harbor” provision under the anti-kickback statute for rebates paid to pharmacy benefit managers (PBMs) by manufacturers after the point of sale for a prescription drug. One major question is: Will this weaken the rebate trap that biosimilars often find themselves in?

Incorporating Natural Hazards And Distributed Infrastructure Into Risk Management For Biopharma Operations
 
By Mark Vessely, BGC Engineering, Inc., and Christina Vessely, Biologics Consulting, Inc.

Natural hazard events may seem like distant topics to some in the biopharmaceutical industry, but they hold relevance for all companies. Opportunities exist for risk management, including an important lesson in avoiding the gradual acceptance of such events as normal until an even greater catastrophic event occurs.

Industry Insights
Why, Why, Why… ELISA? A Look At The Benchmark HCP Assay
Article | By Joe Hirano, GE Healthcare Life Sciences

Biologics developers and manufacturers demand an accurate and reliable assay for host cell protein (HCP) quantitation. Let’s take a close look at why analytical scientists turn to the ELISA, and how it fits into process development.

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