The Process Development Blog

A lack of process understanding & control leads to: inability to scale, product quality drift, & costly delays from batch failures & regulatory concerns

Tech transfer of Advanced Therapy Medicinal Products (ATMPs) presents additional challenges beyond those faced when transferring more traditional biologics.

A comprehensive development history is vital for addressing CMC queries. Digitalization ensures an accurate and complete CMC story for every medicine.

In this case study, operating temperatures had an impact on process performance attributes and product quality resulting in a variable purification step.

[Webinar] Explore the benefits of applying CFD to better understand your process.

ATMP's represent an area of burgeoning development and rapid growth in the pharma industry. But manufacturing infrastructure & capacity must keep pace

Optimizing cell culture media directly impacts cell growth, yield, and biotherapeutic quality, enhancing productivity and cost-efficiency.

[Webinar] Learn more about the use of Continuous Processing for Crystallization.