Articles by Laura Bush - BioPharm International

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Articles by Laura Bush

The Challenge of Defining the Higher Order Structure of Biopharmaceutical Products

Mar 5, 2010

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.

Lessons from the War on Terrorism

Sharing information is a critical part of security—whether we're protecting travelers from bombs or patients from adulterated medicines.
Mar 1, 2010

Sharing information is a critical part of security—whether we're protecting travelers from bombs or patients from adulterated medicines.

What Will Pfizer Do With 79 Manufacturing Plants?

Feb 12, 2010

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?

QbD Gains Momentum

One might look at QbD's plodding growth and conclude that it is never going to make it to graduation.
Feb 1, 2010

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

Regulatory Relief: An Idea Whose Time Has Come

QbD has always embraced the notion that companies could make certain process changes without regulatory oversight.
Jan 1, 2010

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

Quality by Design A-MAb Case Study Challenges Conventional Thinking

Dec 10, 2009

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.

Vetter Launches New US Facility for Clinical Trial Materials

Dec 2, 2009

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.

Speeding Up Slowly

Do we really have to choose between saving money and saving time?
Dec 1, 2009

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

Manufacturing Problems Again Hold Up FDA Approval of Genzyme's Large-Scale Production of Lumizyme

Nov 17, 2009

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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