From the Editor

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

Pushing frontiers in a maturing biotechnology industry.

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.

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

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.

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.

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.

Disposables are no longer a mistrusted new technology; they're seen as a potential solution to everyday problems.

The recent FDA decision that meat from cloned animals is safe for human consumption seems logical enough. A protein is a protein. But even if we can eat such meat, it doesn't necessarily make economic or ecological sense to do so.

In various races in the November elections, voters supported stem cell research. Now, will they prepared to fund it?

Whether it's for manufacturing drugs, characterizing cell substrates, or regulating new technology, quality systems provide a needed framework.

Taking a purist stance is always tempting. It can, however, have unintended consequences.

Is it possible to reconcile phage therapy, which is inherently variable, with requirements for tight product characterization and control?

The approvals of two groundbreaking vaccines in the last month is encouraging news. Vaccines have long been undervalued because they haven't been as profitable as other pharmaceuticals. So it's good to see them getting deserved attention that goes beyond fears of flu outbreaks.

The belief that glycosylation is critical to ensuring the functionality of protein therapeutics-and preventing immunogenicity-drives many manufacturing decisions. But is it time to question this industry tenet?

Alexander Fleming's original process for making penicillin was a low-volume, and presumably, labor-intensive affair. Today, it is a highly optimized, low-budget operation that is carried out only overseas. In other words, says Wei-Shou Hu, PhD, of the University of Minnesota, we engineered ourselves out of a job. Could we do the same with mammalian cell culture? Hu posed this question during a presentation at the BIO conference in April.

In recent years, FDA has made positive moves to foster innovation by streamling regulation. But the agency's recent proposal to exempt manufacturing for phase 1 clinical trials from GMP requirements seems ill advised.

In recent days, several different colleagues, in separate conversations about the industry, made remarkably similar comments.

At a recent scientific conference, a group gathered around a table to compare experiences. Participants, in turn, asked their colleagues how to avoid problem X or how to resolve challenge Y. In most cases, those responding said, "I have found method Z to work, but not all the time." In other words, it depends. Hearing about others' approaches is helpful, but each problem still must be solved individually.

Sometimes, being human is a drag. Especially in winter. The days are short and cold; the nights are longer and colder. In the gray light of midday, it's tough to be enthusiastic about anything.