Taking on the Challenges

The challenges facing the industry as a whole are increasing the pressure on manufacturing organizations to lower costs. At the same time, it seems, we need to find ways to do just about everything faster, including responding with greater agility to changing conditions—including evolving pipelines, developments in process technologies, and pandemic outbreaks and bioterrorism.

To achieve these daunting goals, the industry needs practical problem-solving, a willingness to take risks and provide examples for others, and vision. All of those were on view at the BioProcess International conference in September.

Laura Bush

For example, speakers from Acceleron and BioMarin provided gutsy examples of how quickly plants can be built with single-use systems and minimal piping. They went from design to first batch in 18 months or less! The five or six years typically needed to build a plant is a major cause of today's capacity glut: At five years out, capacity need projections simply are not very accurate. If we can wait to build until two years before a plant is needed, we can respond better to changing conditions—in drug pipelines and bioprocessing methods—and put a lot less capital at risk.

Of course, single-use technologies aren't a panacea. They probably won't ever be suitable for all processes, and many companies need to make use of an existing manufacturing base. Carol Basey of Genentech provided valuable lessons in how to find flexibility in established plants. When addressing gaps in facility fit at the company's plant in Vacaville, California, she looks for operational solutions, which are generally quicker and cheaper than the other options—process intensification and equipment modification. For example, to deal with insufficient buffer capacity, instead of using a new resin with greater binding capacity (process intensification) or installing a bigger tank (an equipment change), it may be simpler, cheaper, and faster to filter and re-batch the buffer.

Jon Coffman of Pfizer, however, raised this kind of problem-solving to another level, taking it from practical to visionary. And although he addressed the issues in hypothetical terms, his theory was firmly grounded in experience.

First, he challenged current assumptions about speed. A government agency recently asked an industry task force how fast a million doses of a new therapeutic antibody could be manufactured to treat a bioterror agent. The panel's answer: 14 to 15 months. Coffman counters that we can do much better. In fact, making some aggressive but realistic assumptions about how quickly certain steps could be done, he says we could produce 100 kilograms of a new MAb in just 60 to 90 days.

We also can significantly lower manufacturing costs, he said. In traditional industry thinking, the expense of manufacturing MAbs means they must be targeted at deadly diseases like cancer, for which you can charge a high price. But what if instead of needing to charge $10,000 per treatment, $100 was enough? Then, we could bring in the same revenue by treating 50 million patients instead of 50,000. This would enable us to target a broader range of diseases, and sell to the masses. This is indeed possible, he asserted, although work still needs to be done to make it a reality.

The need to improve biomanufacturing's responsiveness and costs is driven by larger pressures that threaten the overall structure of the industry. That is why I found it so inspiring to hear experienced industry experts say that we can overcome these hurdles in a way that not only helps the industry survive, but that also enables the industry to serve patients better. In difficult times like these, that is the kind of problem-solving and leadership we need.

Laura Bush is the editor in chiefof BioPharm International, lbush@advanstar.com