Increasing Efficiency and Throughput with Separation and Purification

Increasing efficiency and throughput in downstream separation and purification performance is currently a major focus in the biopharmaceutical industry. Traditional TFF systems cannot be scaled in a linear fashion to meet the projected demand for fermentation and cell culture based products. NCSRT has created a patented line of filtration solutions that address the bottlenecks currently experienced as biopharmaceutical products scale up from clinical trials to blockbuster production quantities.

SmartFlow TFF: NCSRT's novel SmartFlow technology incorporates a patented ribbed design that forces uniform flow across the entire membrane surface unlike traditional TFF cassettes. The incorporation of these unique ribs is the result of applying this practical design approach to TFF fuid dynamics. The improved fluid dynamics extends the performance well beyond what is possible with traditional TFF.

OPTISEP SmartFlow Module Performance: NCSRT customer application data shows significant improvements in cell harvesting applications as compared to other TFF formats and combinations of centrifuges and dead end filtration. Independent tests demonstrate the higher flux and increased throughput of the OPTISEP modules in E. Coli harvest (Figure 1).¹

Figure 1

For cell harvesting or clarification applications, target protein recoveries consistently achieve >99% recovery in optimized SmartFlow TFF systems. Chubet et al. report a scale up strategy to achieve over 99% target protein recovery using a novel single module filtration process to harvest, concentrate, and diafilter SARS-CoV spike protein from insect cell culture at the 1,000- liter scale.² Kopf and Kacmar demonstrate the effect of membrane polymer chemistry at high shear (12,000 sec-1) on protein recovery from CHO cell culture (Figure 2).³

Figure 2

The performance advantage provided by OPTISEP SmartFlow TFF also applies to protein concentration applications.

OPTISEP filter modules accommodate ultra, micro, and nano filtration, and reverse osmosis membranes, enabling optimal processing solutions in the laboratory, pilot plant, and manufacturing suite. The modules are available in the variety of pore size, polymer, and supports. The OPTISEP product family provides direct linear scale up without loss of efficiency from 1 ft.² (0.09 m² ) to full systems operating over 8560 ft.² (800 m² ).

References

1. Davies ET, Tellez M, and Unger M. Isolation of proteins from fermentation broth of high cell density with a new cross flow filtration. Aachen Membrane Colloquium Proceedings. Aachen, Germany; 2005 Apr.

2. Chubet R, Kacmar J, and Kopf H. Development of a novel platform FF system for insect cell culture harvest. Advances in Separations and Purification Supplement to Biopharm Int. 2006; Jun 3.

3. Kopf H and Kacmar J. The effects of membrane pore size, material composition and volumetric challenge on flux performance and protein passage from CHO cell culture. Antibody Development and Production. Carlsbad, CA; March 1-3.

Company info

NCSRT, Inc.

1000 Goodworth Dr.

Apex

NC 27539

Tel: 919.387.8460

Email: mvanderhoff@ncsrt.com

Website: www.ncsrt.com