Newsletter | October 24, 2024

10.24.24 -- Why Aren't QC Labs Fully Automated Yet?

FEATURED EDITORIAL

What To Do When Regulatory Findings Need Quality Risk Management Action

More than half of all recent warning letters issued by the FDA include citations for absent or incomplete risk assessments. This article examines what regulators are looking for.

Expert Voices: Why Aren't QC Labs Fully Automated Yet?

Leading automation experts chime in on why QC labs, otherwise ideal for robotics, have been slow to adopt and standardize the technology.

INDUSTRY INSIGHTS

Quantitation Of Retrovirus-Like Particles (RVLPs) In CHO Derived Products

Application Note | MilliporeSigma

Review key methods which are applied to ensure safety of such recombinant proteins, with a focus on alternate and superior methods to the standard transmission electron microscopy (TEM) method.

NEWS HEADLINES

European Medicines Agency Confirms Acceptance Of Marketing Application For AVT03, A Proposed Biosimilar To Prolia® And Xgeva®

US FDA Approves Dong-A ST's IMULDOSA (ustekinumab-srlf), A Biosimilar To STELARA

Henlius Shines At CPHI Worldwide 2024, Expanding New Opportunities For International Collaboration

Fresenius Kabi lLaunches Tyenne7®*, The First And Only Approved tocilizumab Biosimilar In Canada

SOLUTIONS

Early Drug Development Made Easy With Small Quantities