Articles by Laura Bush - BioPharm International

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Articles by Laura Bush

The Outlook for Quality by Design

The complexity of Quality by Design leads naturally to questions of how much work it requires, how many companies have the resources to do it, and what the payoff is for anybody.
Sep 1, 2008

The complexity of Quality by Design leads naturally to questions of how much work it requires, how many companies have the resources to do it, and what the payoff is for anybody.

Determining Critical Quality Attributes Forms the Foundation for QbD Implementation

Aug 12, 2008

Since the principles of Quality by Design (QbD) for pharmaceutical manufacturing first emerged a few years ago, many companies have been struggling to understand the key concept of design space?what it is exactly, and how to establish it.

GMPs in Phase 1: Take 2

Because less is known about drugs in early development, quality systems are even more important at this stage.
Aug 1, 2008

GMPs in Phase 1 is more important now than ever before.

Biotech's New Frontiers

Just as antibody production is hitting maturity, areas like personalized medicine are presenting new difficulties.
Jul 1, 2008

Pushing frontiers in a maturing biotechnology industry.

BSPA Roundtable Addresses Disposal of Disposables

Jun 11, 2008

As the use of disposable bioprocessing equipment has increased, a new question is gaining prominence: What is the best way to dispose of the equipment after use?

Funding the FDA, Finally

Increased agency funding, whether through budget allocations or user fees, will not prevent another heparin crisis.
Jun 1, 2008

A stronger FDA will benefit both the industry and the public. And it now looks like we are starting down a path to build up that strength.

Straightforward Guidance

The FDA's current approach to process validation can be boiled down to one straightforward concept.
May 1, 2008

In the context of process validation, the confirmation of a belief must be checked repeatedly, throughout the product lifecycle.

What We Don't Know May, In Fact, Hurt Us

Now is a good time for companies to know their suppliers well.
Apr 1, 2008

Now is a good time for companies to know their suppliers well.

Biogenerics Conference Addresses Scientific and Regulatory Issues Surrounding Biosimilars

Mar 12, 2008

When considering how follow-on biologics will be compared to innovator products, Emily Shacter has a favorite question

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