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.

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.

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.

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.

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 is more important now than ever before.

Pushing frontiers in a maturing biotechnology industry.

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?

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.

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

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

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

The cause of the heparin crisis is still unknown. We do know, however, that the FDA is severely underfunded.

A public database of extractables and leachables data would save time, effort, and costs during drug development, agreed participants at the CMC Strategy Forum on Extractables and Leachables on January 27.

The US FDA has requested nearly $2.4 billion for its fiscal 2009 budget, a 5.7% increase over the budget that FDA received for the current fiscal year.

In our increasingly global industry; foreign manufacturing inspections are more important than ever.

The number one source of job satisfaction? A sense of accomplishment from a job well done.

Our second annual salary survey assesses not only how much people earn, but also how they feel about it.

Many companies acknowledged that Western regulatory standards are tougher than those in China.

The challenge is not in coming up with a list of activities to discard, but in finding a feasible way to stop doing them.

The upcoming Quality by Design (QbD) pilot program for biotech filings will focus on comparability protocols, Helen Winkle, director of the Office of Pharmaceutical Science at the FDA's Center for Drug Evaluation and Research, said on September 20, 2007.

Today, product costs, not process science, cause the most concern.

In analyzing the industry's current challenges, let's be careful before extrapolating about what they mean.

The corruption of China's food and drug sectors is not limited to one man. Likewise, real reform will require the efforts of many.

Quality guidelines are only as good as their implementation.

Without charges for some large merger deals, the publicly traded US biopharmaceutical industry would have been profitable in 2006-for the first time.

Fortunately for all of us, not everyone's head is in the sand.

Financial pressure to show short-term results also affects the pharmaceutical industry, from Big Pharma to small biotech.

The biopharmaceutical industry has gained a lot of experience in monitoring glycosylation, but still has a lot to learn about the structure–function relationship.

The United States Pharmacopeia (USP, Rockville, MD, www.usp.org) and the UK's National Institute for Biological Standards and Control (NIBSC, Hertfordshire, UK, www.nibsc.ac.uk) are seeking participants in a study of analytical methods used by the industry to characterize and quantify oligosaccharides.