kbi case studies: process development

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KBI Case Studies Process Development Improving Titer Toolbox for Product Quality Optimization High Throughput Process Development Using Microbioreactors High Cell Density Process

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Page 1: KBI Case Studies: Process Development

KBI Case StudiesProcess Development

Improving Titer

Toolbox for Product Quality Optimization

High Throughput Process Development Using Microbioreactors

High Cell Density Process

Page 2: KBI Case Studies: Process Development

Improving Titer

Toolbox for Product Quality Optimization

High Throughput Process Development Using Microbioreactors

High Cell Density Process

KBI Case StudiesProcess Development

Page 3: KBI Case Studies: Process Development

KBI Case Studies | Process Development

Improving Titer

Objective:

● Increase titer compared to the process transferred to KBI

Outcome:

● Through feed and supplement optimization, KBI routinely improves titer several fold compared to the process transferred to KBI

Page 4: KBI Case Studies: Process Development

KBI Case Studies | Process Development

Improving Titer

Page 5: KBI Case Studies: Process Development

Improving Titer

Toolbox for Product Quality Optimization

High Throughput Process Development Using Microbioreactors

High Cell Density Process

KBI Case StudiesProcess Development

Page 6: KBI Case Studies: Process Development

KBI Case Studies | Process Development

Objective:

● Modify product quality to match a predetermined target through use of a toolbox of strategies around raw materials and process conditions

Outcome:

● KBI has a toolbox of strategies to optimize galactosylation, fucosylation, mannonse-5, glycation, and charge distribution

Toolbox for Product Quality Optimization

Page 7: KBI Case Studies: Process Development

KBI Case Studies | Process Development

Toolbox for Product Quality Optimization

Page 8: KBI Case Studies: Process Development

Improving Titer

Toolbox for Product Quality Optimization

High Throughput Process Development Using Microbioreactors

High Cell Density Process

KBI Case StudiesProcess Development

Page 9: KBI Case Studies: Process Development

KBI Case Studies | Process Development

Objective:● Demonstrate microbioreactor scalability and shorten

process development timeline by using microbioreactorsOutcome:● KBI has demonstrated scalability of ambr microbioreactors

and has integrated this technology in process development workflow. Use of microbioreactors can reduce process development timeline by 1 – 2 months.

High Throughput Process Development Using Microbioreactors

Page 10: KBI Case Studies: Process Development

KBI Case Studies | Process Development

High Throughput Process Development Using Microbioreactors

Days Days

Via

ble

Cel

l Den

sity

(10

^6 c

ells

/mL)

Via

bilit

y (%

)

Page 11: KBI Case Studies: Process Development

Improving Titer

Toolbox for Product Quality Optimization

High Throughput Process Development Using Microbioreactors

High Cell Density Process

KBI Case StudiesProcess Development

Page 12: KBI Case Studies: Process Development

KBI Case Studies | Process Development

Objective:● Develop high cell density processes using ATFOutcome:● KBI has developed high cell density processes (>100

million cells/mL) with improved viability and product quality profiles.

High Cell Density Process

Page 13: KBI Case Studies: Process Development

KBI Case Studies | Process Development

High Cell Density Process

Page 14: KBI Case Studies: Process Development

www.kbibiopharma.com

PO Box 155791101 Hamlin RoadDurham, NC 27704

Tel: +1 919 479 9898

Contact Us

Page 15: KBI Case Studies: Process Development