Laura Bush

Following its recent acquisition of Wyeth, Pfizer has 79 manufacturing plants around the world?43 from Pfizer and 36 from Wyeth-and relationships with about 250 contract manufacturers. It?s a wealth of resources, which altogether make 32,000 SKUs. Now, how to consolidate it all?

One might look at QbD's plodding growth and conclude that it is never going to make it to graduation.

QbD has always embraced the notion that companies could make certain process changes without regulatory oversight.

When the CMC Biotech Working Group began developing a case study on applying Quality by Design (QbD) to biotech products, the goal was to challenge conventional thinking on the subject.

The German fill-finish provider Vetter inaugurated a new US facility in Skokie, IL, just outside Chicago, along with a new subsidiary, Vetter Development Services USA Inc.

Do we really have to choose between saving money and saving time?

Following a five-week inspection of Genzyme's plant in Allston Landing, MA, the US Food and Drug Administration is still not satisfied with the company?s large-scale manufacturing of Lumizyme.

What football and bioprocessing both have in common is that in both cases, success is a minimum requirement.

The Korean CMO Celltrion and Hospira, a small-molecule injectable generics and drug delivery company based in Lake Forest, IL, agree to co-market biosimilars developed by Celltrion.

Diminutive bacteria with the right geometry (i.e. very thin) may be useful for research and development work on sterilizing-grade and other 0.2 uM filters, said Kurt Brorson, PhD, a staff scientist for the FDA/CDER's Division of Monoclonal Antibodies.