KBI Case Studies discusses four process development case studies: 1) Improving Titer - KBI routinely improves titer several fold compared to original processes through feed and supplement optimization. 2) Toolbox for Product Quality Optimization - KBI uses strategies around raw materials and process conditions to optimize product quality attributes like galactosylation. 3) High Throughput Process Development Using Microbioreactors - KBI has demonstrated microbioreactor scalability and integrating this technology reduces process development timelines by 1-2 months. 4) High Cell Density Process - KBI has developed high cell density processes exceeding 100 million cells/mL with improved viability and quality profiles using alternating tangential flow technology.

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

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

3. 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

4. KBI Case Studies | Process Development
Improving Titer

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

6. 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

7. KBI Case Studies | Process Development
Toolbox for Product Quality Optimization

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

9. KBI Case Studies | Process Development
Objective:
● Demonstrate microbioreactor scalability and shorten
process development timeline by using microbioreactors
Outcome:
● 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

10. KBI Case Studies | Process Development
High Throughput Process Development Using Microbioreactors
Days Days
ViableCellDensity(10^6cells/mL)
Viability(%)

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

12. KBI Case Studies | Process Development
Objective:
● Develop high cell density processes using ATF
Outcome:
● KBI has developed high cell density processes (>100
million cells/mL) with improved viability and product quality
profiles.
High Cell Density Process

13. KBI Case Studies | Process Development
High Cell Density Process

14. www.kbibiopharma.com
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1101 Hamlin Road
Durham, NC 27704
Tel: +1 919 479 9898
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