Feb 11, 2009
By:
Laura Bush
Even the best biotech companies lack a crystal ball. In 2003, Genentech had a shortage of manufacturing capacity. So they started an internal campaign, called "Every Gram Counts," to produce as much as possible.
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How change plays out will depend not only on the new Whitehouse, but on pharma leaders' ability to adapt to changing times.
Feb 1, 2009
By:
Laura Bush
How change plays out will depend not only on the new Whitehouse, but on pharma leaders' ability to adapt to changing times.
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Clearly the curse "May you live in interesting times" is upon us.
Jan 1, 2009
By:
Laura Bush
Looking ahead at the biopharmaceutical industry into 2009.
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Dec 10, 2008
By:
Laura Bush
The US Food and Drug Administration has issued a new draft guidance document on process validation. This much-awaited revision of the 1987 guidance of the same name has been in the works for at least three years, and is being welcomed by industry experts.
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This guidance manages to explain the underlying concepts of Quality by Design without every using the phrase.
Dec 1, 2008
By:
Laura Bush
The FDA's revised process validation guidance manages to explain the underlying concepts of Quality by Design without every using the phrase.
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The disposables based facility produced 25% less carbon dioxide than the stainless steel–based facility.
Nov 1, 2008
By:
Laura Bush
Despite creating plastic waste, the disposables option is better for the environment.
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Oct 8, 2008
By:
Laura Bush
New investments by two different pharmaceutical companies in programs to manufacture biologics in tobacco plants are reviving hope in the promise of plant-made pharmaceuticals.
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We are already paying for a lot of care for the uninsured in a very indirect, untransparent, and inefficient way.
Oct 1, 2008
By:
Laura Bush
The country is reeling from US Treasury Secretary Henry Paulson's proposed $700 billion Wall Street bailout. In appealing for support, Paulson stressed this was a crisis. This sense of urgency is reminiscent of the way millions of Americans without health insurance cope with medical problems—in the emergency room, because they have no access to routine and preventive care.
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Sep 23, 2008
By:
Laura Bush
In biomanufacturing today, there is increasing focus on improving process development. The goal is to accelerate development and reduce costs, without compromising the ability to scale up to a robust commercial process later on.
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