Mar 5, 2010
By:
Laura Bush
Characterizing the higher order structure (HOS) of protein drugs increases manufacturers' understanding of stability and batch-to-batch variability, and may make it possible to link variants or aggregates to safety and efficacy. Yet at the January 24 CMC Strategy Forum in Washington, DC, regulators expressed concern that methods to characterize the three-dimensional structure of proteins are not routinely applied to biotechnology products.
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Sharing information is a critical part of security—whether we're protecting travelers from bombs or patients from adulterated medicines.
Mar 1, 2010
By:
Laura Bush
Sharing information is a critical part of security—whether we're protecting travelers from bombs or patients from adulterated medicines.
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Feb 12, 2010
By:
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?
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One might look at QbD's plodding growth and conclude that it is never going to make it to graduation.
Feb 1, 2010
By:
Laura Bush
One might look at QbD's plodding growth and conclude that it is never going to make it to graduation.
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QbD has always embraced the notion that companies could make certain process changes without regulatory oversight.
Jan 1, 2010
By:
Laura Bush
QbD has always embraced the notion that companies could make certain process changes without regulatory oversight.
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Dec 10, 2009
By:
Laura Bush
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.
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Dec 2, 2009
By:
Laura Bush
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.
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Do we really have to choose between saving money and saving time?
Dec 1, 2009
By:
Laura Bush
Do we really have to choose between saving money and saving time?
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Nov 17, 2009
By:
Laura Bush
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.
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