Laura Bush

After 18 years, Human Genome Sciences (HGS, Rockville, MD) may soon have its first drug on the market. And thanks to a bold scale-up strategy, HGS?s manufacturing organization is ready.

A single standard should apply to all comparability exercises for biologics, be they for biosimilars or manufacturing changes.

As part of a news series on the H1N1 influenza pandemic, BioPharm International interviewed Ben Machielse, Drs., executive vice president of operations at MedImmune, to ask about his company's experience manufacturing vaccines against H1N1.

In February, we reported on Pfizer's plans for reconfiguring its global manufacturing network of 79 plants, following its recent acquisition of Wyeth. Now, we have the answer.

New R&D models must be tried, but it will take time to see if they work. In the meantime, a new kind of threat is on the horizon: biobetters.

Now is not an easy time to lead a pharmaceutical company. The patent cliff is fast approaching, pipeline challenges remain, capital markets are tight, and the blockbuster model is fast on its way out. Meanwhile, regulations on sales and marketing continue to tighten.

We all know that experience is the best teacher. With H1N1, we have a great opportunity to learn important lessons.

Given today's challenges, traditional strategies were bound to change. Now, there is one more big threat (or opportunity?) on the horizon.

Characterizing the higher order structure (HOS) of protein drugs increases manufacturers' understanding of stability and batch-to-batch variability, and may make it possible to link variants or aggregates to safety and efficacy. Yet at the January 24 CMC Strategy Forum in Washington, DC, regulators expressed concern that methods to characterize the three-dimensional structure of proteins are not routinely applied to biotechnology products.

Sharing information is a critical part of security-whether we're protecting travelers from bombs or patients from adulterated medicines.