Laura Bush

Laura Bush was editor in chief of BioPharm International.

Articles by Laura Bush

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New Adventures

Biotech, and bioprocessing more specifically, is a great place to be. But it's time for a new adventure.

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Tug of War

Regulatory relief requires that regulators trust companies to know what they are doing, and to do it-consistently.

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A single standard should apply to all comparability exercises for biologics, be they for biosimilars or manufacturing changes.

As part of a news series on the H1N1 influenza pandemic, BioPharm International interviewed Ben Machielse, Drs., executive vice president of operations at MedImmune, to ask about his company's experience manufacturing vaccines against H1N1.

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New R&D models must be tried, but it will take time to see if they work. In the meantime, a new kind of threat is on the horizon: biobetters.

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.

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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QbD Gains Momentum

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

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