Newsletter | January 16, 2025

01.16.25 -- Become A cGMP "Special Agent" With A License To Care

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With a third wave of biologics patents expiring, the race is on to seize the booming opportunities in the fast-evolving biosimilars field. What’s driving the patent scramble? What hurdles in manufacturing, regulation, and market access must be cleared for biosimilars to thrive? And how are global industry leaders carving out strategies to dominate the market? Don’t miss Bioprocess Online Live happening February 4th. Registration is completely free, thanks to the support of Cytiva and Ecolab Life Sciences.

FEATURED EDITORIAL

Deploy AI To Become A cGMP "Special Agent" With A License To Care

Addressing systemic cGMP issues requires more than technical fixes — it demands organizational transformation. Thoughtfully applied, AI can empower professionals to become "special agents" of quality, equipped with a "license to care."

11 Key Contributing Factors For Maintaining Sterility Assurance

Containers and closures, depyrogenation, equipment, materials, personnel, and 7 more major factors all contribute to sterility assurance.

INDUSTRY INSIGHTS

End-To-End Analytical Solutions For Biologic Development

Discover comprehensive, state-of-the-art analytical services that ensure quality, safety, and regulatory compliance throughout every stage of your biologic drug’s lifecycle.

NEWS HEADLINES

GlycoNex Announces Licensing Agreement For SPD8 Biosimilar

AAM Applauds Senate Bill To Protect Patient Access To Affordable Medicines

Xbrane Files BLA For Ranibizumab Biosimilar Candidate To FDA

SOLUTIONS

Multivariate Inter-Stage Batch Profile Monitoring And Future State Estimation