Standardized, Hands-on Biomanufacturing Training is Essential

Several years ago, after conducting yet another disappointing job interview, I realized that the only way I was going to find competent manufacturing professionals was to steal them from the biomanufacturing plant down the street or train existing ones. Not wanting to design my own comprehensive in-house training program, I decided to join a team that would design the concept for a revolutionary new training center. The new center's aim was to produce graduates and trainees that know about current good manufacturing practice (cGMP) compliance, understand the basics of unit operations, and have actually touched a working bioreactor or utility skid.

Rick Lawless

Educators, industry professionals, and government officials worked together to secure a grant for almost $39 million to build the Golden LEAF Biomanufacturing Training and Education Center (BTEC) at North Carolina State University. It took another $7 million from state government and donations from local industry to install the initial process equipment.

The center is now the largest of its kind in the world and is consistent with the NC State University mission to produce graduates who hit the ground running. BTEC provides hands-on education and standardized training for manufacturing biomolecules. The curriculum was designed using data from a survey of local industry professionals conducted by the North Carolina Biotechnology Center.¹

Introductory courses teach students the fundamentals of cell growth and biomolecules. Intermediate courses help students transition from bench-scale to industry equipment. In the advanced courses, students are exposed to cGMP, large-scale equipment issues, and clean utilities. The scope of learning is broader than what a new employee would experience on the job, so graduates with a minor in biomanufacturing are uniquely qualified and can tackle most first assignments with ease.

I was so convinced of the long-term value of the center and its potential to support industry growth that I went to work for BTEC in 2006. For companies, BTEC is cost efficient and produces graduates with skills that can be easily modified to fit company procedures. BTEC students learn to work in clean rooms, document their work, and conduct failure investigations. They also learn how to read engineering drawings and can list the components of clean utility systems and explain the function of each.

Most importantly, after assembling and disassembling bioprocessing equipment, troubleshooting leaky vessels and plugged valves, and reacting to other operational failures, students come out of the class with wealth of knowledge and skills. BTEC is also charged with keeping up with, and even creating, technology improvements and revising its curriculum accordingly. Skilled professionals are important now, and will be even more important as Big Pharma companies try to reduce costs to reach new markets in developing countries and compete against manufacturers of follow-on biologics.

Early BTEC successes include growing enrollment, high placement rate, and several training and development contracts. The ultimate proof of BTEC's success will come as companies expand or build new plants in NC and when former students return to BTEC to recruit for the new positions that have been created.

Rick Lawless is an associate director at the Golden LEAF BTEC, NC State University, Raleigh, NC, 919.513.0969, rick_lawless@ncsu.edu

REFERENCES

1. North Carolina Biotechnology Center; North Carolina Biomanufacturing and Pharmaceutical Training Consortium. The model employee: preparation for careers in the biopharmaceutical industry, Raleigh, NC;2005 May.