BPD%202009%20Poster_GLG

Upstream Capabilities

Analytical Capabilities

BTEC’s Bioprocess Service CapabilitiesGary Gilleskie, Ph.D.

Golden LEAF Biomanufacturing Training and Education Center, North Carolina State University

Since opening in fall 2007, the Golden LEAF Training and Education Center (BTEC) has been preparing a skilled workforce for the demands of the biomanufacturing industry. Now BTEC offers its facilities, equipment, and expertise to solve some of the industry’s toughest technical problems. Our bioprocessing services initiative, which was established in the latter half of 2008, allows clients to take advantage of our capabilities in bioprocess development, protein manufacture (non cGMP), analytical method development, routine analytical testing and biomanufacturing technology development.

2009 has been an active year for the initiative. BTEC faculty and staff have provided services to several industry partners and to groups within NCSU. The list of projects includes E. colifermentation runs (for protein production) at 300-L scale, several different projects testing single-use, disposable bioreactor technology for animal (CHO) cell culture, HPLC method development applied to small biomolecules, and peptide identification by MALDI-TOF mass spectrometry.

So what are BTEC’s bioprocessing capabilities? This poster provides the details. BTEC’s analytical testing capabilities are described in a separate poster entitled “BTEC Analytical Capabilities.”

Downstream Capabilities

Bench- and production-scale Niro Soavi homogenizers for cell lysis

max pressure = 1000 bar

Introduction

Bench- and production-scale disc-stack centrifuges from Westfalia and Alfa Laval for cell recovery and clarification

∑= 5230 m2

GE Healthcare AKTA systems, for use with all types of chromatography – ion exchange, reversed phase, hydrophobic interaction, size exclusion, and affinity

Up to 180 L/h

Support Systems

BTEC’s downstream capabilities include those technologies required for production of biopharmaceuticals, including equipment for cell lysis, centrifugation, chromatography, and tangential flow filtration. Equipment scale accommodates both bench-scale studies and pilot-scale production.

A variety of ultrafiltration/ microfiltration units, including the Millipore ETU shown to the left

BTEC has the ability to execute both microbial fermentation and animal cell culture at a range of scales, using fixed, reusable equipment or single-use, disposable technologies. Equipment details are given below.

Fully automated 30-L and 300-L Sartorius fermentors/ bioreactors, SIP- and CIP-capable

Shake flask capabilities ranging from 500 mL to 2 L (no photo shown)

Automated 2-L fermentors/ bioreactors (shown in photo to the left) from Sartorius and Applikon®

Upstream Capabilities, continued

50-L and 250-L HyClone single-use bioreactors

20-L “rocker” bioreactor (Sartorius BIOSTAT® CultiBag RM) using disposable bags

In addition, BTEC’s upstream capabilities include• mass spec for bioreactor off-gas analysis • NIR fermentation analyzers• autosampler for bioreactors• a BSL-2 lab

BTEC is also equipped with a host of support systems required for biopharmaceutical production. These include:

• Glasswasher• Autoclave• Solution Prep Capabilities - up to 600 L prepped per batch and

stored in buffer bags• Variety of process utilities, including clean steam, high purity water

Downstream Capabilities, continued

max pressure = 1500 bar

∑= 1900 m2

Up to 100 mL/min

BTEC’s processing capabilities are complemented by an expanding list of analytical capabilities, which are described in the poster titled “BTEC Analytical Capabilities.”

Up to 5 m2

membrane area