Biomanufacturing Training and Education Center on Centennial Campus Revs Up Bioprocesses and Analytical Services

RALEIGH, NC, January 27, 2011 (Press-News.org) Nearly two years after jumpstarting an initiative to provide bioprocesses and analytical services to pharmaceutical and biotechnology companies, the Golden LEAF Biomanufacturing Education and Training Center (BTEC) on NC State's Centennial Campus continues to see significant growth.

"We're taking on more and more projects as the industry learns about the process development, analytical testing and development, and technology development services we can provide," said Gary Gilleskie, BTEC's associate director operations. "We're currently juggling seven active projects."

The Center recently completed four projects for its corporate clients, including:

- An exhaust filter design study for newly developed disposable cell culture bags
- Scale-up of a mammalian cell culture process for production of a proprietary protein therapeutic to a 50-L disposable bioreactor
- Sweet whey fermentation by Kluyveromyces lactis for production of insect feed
- UPLC for amino acid analysis of tissue culture media

BTEC is the largest facility of its kind in the world and holds more than $12.5 million of industry-standard equipment and a simulated cGMP (current Good Manufacturing Practice) pilot plant facility capable of producing biopharmaceutical products using cell growth and expression, recover and purification processes in a sterile environment. In addition to providing seminars, courses and training to corporate clients, the facility also trains undergraduate and graduate students at NC State and other colleges for jobs that produce medicines, vaccines, diagnostics, enzymes, amino acids, veterinary medicine and related products.

The Golden LEAF Foundation provided startup funds to design, build and equip the Center, which is managed by the College of Engineering. The facility is located on Centennial Campus, NC State's award-winning research park and technology campus.

BTEC's upstream biomanufacturing equipment includes bioreactors ranging from 2-L to 300-L scale, which can accommodate both fermentation and cell culture projects. This includes disposable bioreactor systems, for cell culture applications, with volumes ranging from 10-L to 250-L. BTEC also has the equipment required for protein recovery and purification steps, including high pressure homogenizers, centrifuges, chromatography systems, and tangential flow filtration systems, all in sizes that can accommodate bench-scale and pilot-scale studies.

BTEC's analytical technologies include HPLC, UPLC, multi-mode plate reader, SDS-PAGE, capillary electrophoresis, MALDI-TOF, quantitative PCR, and DNA sequencing. Typical tests performed include ELISAs, Western blots, protein concentration and purity, protein fingerprinting, spectral characterization, MW determinations, host cell DNA contamination, amino acid analysis, TOC analysis, endotoxin, bioburden, and microbial identification.

Other projects the Center has completed since the initiative began include:
- 30-L and 300-L microbial fermentation runs for production of proprietary proteins;
- Scale-up of inclusion body recovery steps for a protein therapeutic;
- Production of a therapeutic vaccine for use in toxicology studies;
- Evaluation of new disposable bioreactor prototypes;
- Analysis of a small molecule tumor suppressant in chicken plasma;
- Screening for anti-viral properties among proprietary small molecules; and
- HPLC for quantifying relative amounts of isoflavones in soybean samples.
For more information on BTEC's process development and analytical services, contact Gary Gilleskie at (919) 515-0176 or gary_gilleskie@ncsu.edu.

About Centennial Campus and NC State University
Centennial Campus (http://www.centennial.ncsu.edu) is an internationally recognized 1,314-acre research park and technology campus owned and operated by North Carolina University. Home to more than 60 corporate, government and non-profit partners, such as Red Hat, ABB, and the USDA, collaborative research projects vary from nanofibers and secure open systems technology to serious gaming and biomedical engineering. Four university college programs also have a significant presence on campus - College of Engineering, College of Veterinary Medicine, College of Textiles and the College of Education. NC State is one of the top research universities in the country, with expenditures in research approaching more than $325 million annually. The university ranks third among all public universities (without medical schools) in industry-sponsored research expenditures. (http://www.ncsu.edu)