Newsletter | January 30, 2025

01.30.25 -- New Regulatory Survey Findings: Biotech Market Access Challenges

SPONSOR

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

A Justification For Using In-Process Controls In Place Of Cleaning Validation

This article provides a procedure for using and cleaning shared columns and column packing equipment and using in-process controls that eliminate the need for cleaning validation.

New Regulatory Survey Findings: Biotech Global Market Access Challenges And Learnings

To understand biotech companies’ evolving geographic strategies and perceptions, Arriello recently commissioned a transatlantic survey among regulatory, safety, and quality directors at small/medium biotechs, with respondents in Ireland and North America.

INDUSTRY INSIGHTS

3 Ways To Maximize The Benefits Of Your CDMO Partnership

An experienced CDMO partner can help bridge the gap from lab scale to clinical and commercial scale while sharing the critical insights needed to launch a biologic manufacturing program.