Tailored Services Backed by Media Expertise
Outsourcing Media Optimization to Increase Process Robustness and Performance
For drug producers, maximizing yield without compromisingproduct quality requires considering all critical parametersin process development to analyze and improve cell culture
conditions. Media performance is linked to several parameters
including the manufacturing process as well as the source andKey Media Development &Optimization Challenges---Unique process & target expectations requirea tailored media formulation .
Designing the right formulation is time- and costintensive.
Media development depends on specific expertiseand dedicated equipment.
High number of component- and concentrationdependent combinations create additionalcomplexity.
Access to manufacturing-grade raw materials is
crucial for low-risk scale-up.

Comprehensive Capabilities
from Benchmarking Studies
to de novo Development---

Adherent to suspension cell line adaptation service
Initial process screening and comparability studies toavailable solutions
Media optimization service based on a library of
existing formulations
Iterative de novo development from scratch to matchprocess performance indicators supported byadvanced data analytics (MODDE® & SIMCA® software)
Cutting-edge media analytical methods & equipment
including the Ambr® system, supporting an iterative,
flexible, & agile approachquality of raw materials. Optimizing a media formulation is
critical to shortening time-to-market and ensuring consistent
output. Combining a rational and research-driven approachwith statistical methods can enable solutions that are bothwell-founded and adaptable to your needs.

Optimizing Process Conditions Using an Integrated,
High-Performance Media & Feed Strategy
Media Rapid Prototyping
Using defined
formulations

Analytics
Understanding cellneeds & controlling
product quality

Media Development
Screening usinginternal libraryMediaOptimization

Developmentde novo

Qualifying product,process, & supplier

Troubleshooting

Adjusting proprietary
formulations

Case Study: Custom Medium Development for AAV Production in HEK293 Cells —Producing > 1.5-Fold Increase in Genomic Titers From Benchmark Study to Final Run
Fresh & spent media
analytics to understandcurrent process

Starting media selection
from scratch or basal
formulation

Cyclic development
testing media variants inthe specific process

Final variant confirmation
at 2 L bioreactor scale,including tech transfer

Frequent expert to expert interactions

Media variants two and three tested in the first development
cycle already showed competitiveness to the benchmark.
Figure 1: AAV2 production in HEK293 cells at shake-flask scale with 6 media
variants from first development cycle. Genomic titer shown as fold change
measured by qPCR 72 hours post-transfection in cell lysates.

12.0

1
0.68

0.9

0.82

0.62
0.38

0.5
0.1
0Benchmark

V1

V2

V3

V4V5V6Media variants identified in the second development cycle
outperformed the benchmark.
Figure 2: AAV2 production in HEK293 cells at shake-flask scale with7 media variants from second development cycle. Genomic titer shown as foldchange measured by qPCR 72 hours post-transfection in cell lysates.

Genomic AAV Titer[Fold Change]

2.0

1.65

1.5
11

0.91

1.04

1.14

1.87
1.54

1.25

0.5
0Figure 3: AAV2 production in HEK293 cells in 2 L benchtop bioreactors with
2 media variants from final development cycle. Genomic titer shown as foldchange measured by ddPCR 72 hours post-transfection in cell lysates.

Benchmark V1V2V3F or more information, visit
sartorius.com

V4V5V6V7

Genomic AAV Titer[Fold Change]

Genomic AAV Titer[Fold Change]

1.5

Before sending to the customer, we tested promisingintermediate variants in 2 L benchtop bioreactors. Bothvariants outperformed the initial benchmark.

1.55

1.5
1

1.47

1

0.5
0

Benchmark

V1V2Services Available as Standalone
or Packaged
Cell line adaptation service
Feed & media optimization service
Feed & media development service
Benchmarking & material testing
Access to our media production capabilities from rapid
prototyping to large scale liquids & powders for further
manufacturing use.

Specifications subject to change without notice.
©2024 Sartorius Stedim Biotech GmbH, August-Spindler-Strasse 11, 37079 Goettingen, Germany
Status: 06 | 2024