News

Posted On: 10/06/2006

Destroying Biopharma Silos

PharmaManufacturing.com

Next year, new drug development and training programs will be introduced in Ireland and in Puerto Rico that attack one of biopharma’s greatest weaknesses: lack of interdisciplinary training and focus. On Sept. 20, Puerto Rico’s Economic Development Board (Pridco) and partners broke ground for a new Bioprocess Training and Development Complex (see Photo below) in Mayaguez, not far from the university.

The new center, due to come onstream next year, will have both a training and an R&D component, says Pridco Executive Director, Boris Jaskille, and its curriculum will focus on process improvement, troubleshooting, tech transfer and consulting. Abbott, Amgen and Ortho representatives are on the new Complex’s board of directors.

Students will include current Mayaguez students as well as manufacturing professionals who work at the island’s biopharma facilities, Jaskille says. The curriculum will soon be finalized, but students will work on pilot- and industrial-scale equipment. Companies will also be able to send their development teams there to scale up new processes.

An architectural drawing of the new Bioprocess Training and Development Complex in Mayaguez, Puerto Rico, a joint project of academia and the pharmaceutical industry.

Set for groundbreaking later this year, and a launch at the end of 2007, is Ireland’s National Institute for Bioprocessing Research and Training. NIBRT is designed to facilitate training, pilot plant scale-up and research in biopharma; it will offer training for pharmaceutical company partners as well as students in its four participating universities. It also will offer process scale-up and research facilities or turnkey services to drug companies.

Students will train on three pilot lines that mimic real GMP environments using realistically scaled equipment, including fermentation units with up to 1500-L capacity, says director Kurt Naujoks.

“Traditionally, with academic training, you’re either becoming a biologist, a chemical engineer or a pharmacist," Naujoks observes. "Here, we’re taking an integrated approach, so that the graduates are better suited to real-life environments, where, say, the engineer needs to talk to the cell-line designer and the regulatory specialist, and where the automation and control specialists need to connect with all three."

A Softer Landing

The facility is expected to meet an acute need. "When people graduate and start to work in the industry, they experience the same shock, since the specialized school training environment is so different from the environment into which they’re thrust," he says. “We believe that this program can soften their landing.”

It will also give industry a way to test processes and scale them up in a safe and dedicated environment, using the latest technologies and methods. Companies can send their teams to the Institute, or outsource the work to researchers based there.

Even though the actual facility is a year away from taking physical shape, NIBRT already has partners. On the industrial side, Organon, the pharma division of Akzo Nobel, will collaborate on research designed to improve the control and understanding of glycosylation in CHO cell culture. Meanwhile, on the academic side, Oxford University’s Glycobiology Institute has moved to Dublin.

Projects at the new center also will test traditional interpretations of FDA limits. "Normally everyone’s trying to be on the safe side, and not challenge FDA’s highly respected statements," says Naujoks. "As an independent institute, we can take a fresh look at what’s actually possible and what would still be valid. After all, people have been making recombinant products for 15 years."