06.13.26 -- Bioprocess Online Newsletter - Best Of May

Join Bioprocess Online's Tyler Menichiello for a live panel with David Scherr, Ph.D. of AstraZeneca and Vadim Klyushnichenko, Ph.D. of Calibr-Skaggs Institute for Innovative Medicines as they explore how biologics teams are improving process efficiency beyond higher titers. Learn practical strategies for simplifying purification, reducing chromatography steps, addressing developability and facility constraints, and optimizing complex molecules like bispecifics. Register now to discover the productivity levers that matter most.

The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications. Here's why the outsourced pharma industry should take note.

A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.

In this Bioprocess Online Live event, our panelists respond to results from an audience poll. Audience members indicated they use PATs for real-time monitoring more in upstream than in downstream.

Clarifying post–virus inactivation streams with a charged depth filter can remove precipitates while significantly reducing HCPs. See how a dual‑layer filtration approach supports stronger impurity control.

Look at how denaturing SEC‑MS uncovers low‑level oligomers and truncated variants in GLP‑1 peptides, offering clarity on impurity profiles and supporting confident assessment of molecular integrity.

GLP‑1 therapies are changing injectable care and driving rapid progress in delivery and manufacturing. Examine how patient needs, emerging tech, and regulations are reshaping chronic treatment.