October 10, 2012

Life Science Industry Forum: Process Robustness

Both John Berra, retired chairman of Emerson Process Management, and Peter Zornio, chief technology officer, introduced the Life Sciences Industry Panel at the Emerson Global Users Exchange—a fact that reflects how important this industry is to Emerson. “Not only important to Emerson,” said Berra, “but to the world.”

Berra reinforced his message that automation is a noble profession, and that automation engineers often toil in obscurity. “Life sciences is especially challenging,” he continued, “with a whole layer of documentation and regulatory requirements” to consider.

Discussing his work at a children’s hospital back home, Berra referred to “the butterfly effect” related to the notion that everything matters, as mentioned by keynote speaker Andy Andrews. Berra told the packed room that “your butterfly wings are echoing through the halls” of the hospital, reflecting “goodness that can be traced back to your efforts as automation professionals.”

Panelists included Scott Bradley of Bradley-James, Lars Petersen of Roche, Ian Allen of Infinity Automation, and Francis Sidnam of Briston-Myers Squibb. Overall, panelists said that the Life Sciences industry has done a good job of automating in a fundamentally vertical way—labs are automated top to bottom, as are clinical trials and full-scale production. The new task is to save money and shorten the development timeline by automating in a horizontal way, so more efficient technology transfer can take place to speed up full-scale production.

A problem is, in many pharmaceutical and biologic companies, no one person sees the drug through the process, from initial lab tests to clinical trials and eventually into full-scale production. This cultural problem has yet to be solved, said panelists.
Better control of experiments at the process development level can increase efficiencies by performing more runs with less data variance, using the same or fewer staff. One speaker used Delta V and realized a three-fold increase in the number of experiments.

The challenge is to provide real-time monitoring of variances, which can result in sometimes very simple steps being taken to “save” a batch. The information must be presented in a way chemists can understand it, one panelist said.

Lars Petersen mentioned a successful tech transfer from pilot plant to phase one clinical trials in as little as 8 weeks, compared to the old timeline of more than 5 months. Petersen also mentioned they discovered, through their process development platform, that 90% of all parameters stay the same. From a validation point of view, this is critical, he said.

“That results in getting the medicine to the patient faster. That’s the ultimate challenge. That’s what we are trying to accomplish,” Petersen said.

Berra encouraged all those in the room to “give back” to the profession. Not everyone can afford to establish a scholarship, but you can donate time, he said. “Or you can lobby your company to provide equipment and labs so the ‘toys’ we play with are readily available on campuses,” he added. Berra paid homage to the robotics industry, giving them credit for sponsoring contests and exposing students to robots early in the education. “Let’s create an awareness that not only are we noble,” Berra said, “but that we are cool.”