11.14.26 -- Bioprocess Online Newsletter - Best of October

The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.

The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, and more.

In this segment from the Bioprocess Online Live event, panelists David Scherr, Ph.D. (AstraZeneca) and Vadim Klyushnichenko, Ph.D. (Calibr-Skaggs), answer the question, “What should developers be thinking about upstream to avoid downstream complications?”

Shift from reactive sampling to continuous, data-driven control. Learn how in-line metabolic monitoring improves yield and batch consistency through real-time glucose and lactate insights.

Streamline mAb purification with confidence. Learn practical considerations for developing processes with advanced mixed-mode chromatography, ensuring superior impurity and viral clearance.

Computational fluid dynamics and metabolic modeling predict gas transfer more accurately than volumetric metrics, improving mammalian cell culture scale-up and process control.