Newsletter | February 24, 2022

02.24.22 -- Cardinal Health Predicts 2022 To Be Turning Point For US Biosimilars

Featured Editorial
Industry Insights
Top Four Considerations For Tech Transfer Performance

Successful tech transfer is how long-term strategic CDMO relationships begin. A product’s continued success may hinge on this critical exchange of product data and required regulatory filings.

Mechanistic Modeling For Downstream Processing: Digital Twins Are Here To Stay

Expensive and time-consuming laboratory experiments, iterative empirical optimization, and even statistical methods alone are not the answers to the challenges of the future. Many global biopharma companies are working on establishing digital twins of their upstream or downstream processes.

Designing Successful Viral Clearance Studies

Despite careful testing of starting materials and in-process intermediates, there is still a risk that a virus could enter the manufacturing process undetected. Here, we review the studies that involve scaling down individual process steps, and, for each step, spiking virus into the specific process intermediate, performing the process step and measuring the virus remaining after the process step.

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