Articles by Laura Bush - BioPharm International

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Articles by Laura Bush

Capacity Planning Challenges Even Genentech

Feb 11, 2009

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.

How Change Plays Out

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

How change plays out will depend not only on the new Whitehouse, but on pharma leaders' ability to adapt to changing times.

Taking on 2009

Clearly the curse "May you live in interesting times" is upon us.
Jan 1, 2009

Looking ahead at the biopharmaceutical industry into 2009.

Revised Draft Process Validation Guidance Emphasizes Process Understanding and Ongoing Monitoring

Dec 10, 2008

The US Food and Drug Administration has issued a new draft guidance document on process validation.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.

The New Era of Process Validation

This guidance manages to explain the underlying concepts of Quality by Design without every using the phrase.
Dec 1, 2008

The FDA's revised process validation guidance manages to explain the underlying concepts of Quality by Design without every using the phrase.

The Environmental Impact of Disposables

The disposables based facility produced 25% less carbon dioxide than the stainless steel–based facility.
Nov 1, 2008

Despite creating plastic waste, the disposables option is better for the environment.

New Investments Revive Hopes for Plant-Made Pharmaceuticals

Oct 8, 2008

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.

Sick Economy, Sick Healthcare System

We are already paying for a lot of care for the uninsured in a very indirect, untransparent, and inefficient way.
Oct 1, 2008

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.

Mastering Process Development: Six Months from Transfection to Pilot

Sep 23, 2008

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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