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EXAMPLES
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Examples of DOE Application in Cell Culture Development
- A researcher uses cell culture to study a cellular
protein secreted in vitro. To continue her experiments, she needs a
larger quantity of the protein than currently available. For this purpose,
the culture needs to be expanded and several scale up options tested,
including feed rate and gas exchange combinations in various culture
vessels.
- A process development specialist uses bioreactors for production
of a glycoprotein. However, the production process could benefit
from a better balance between cost and productivity. The experiments
required to find the right settings could take several weeks, and
time is of essence.
- An R&D researcher has screened several early transfectants
for selection of high-producing candidates using multi-well plates.
Two clones were selected for providing the best specific productivity.
However once tested in bioreactors, productivity shows poor correlation
with earlier findings in multi-well plates. The researcher would
like to retest all transfectants in batch and fed-batch modes but
the number of bioreactors required for the experiment is limited.
- A scientist has selected four medium formulations as best candidates
to support high cell density growth of a hybridoma cell line. He wants
to optimize growth performance by mixing these formulations together
and determining the best mixture combination for the cell line. Experiments
will be performed in bioreactors to minimize scalability issues, and
must include the effect of process factors such as feed rate and temperature
on cell response.
- A laboratory assistant was assigned a research task involving human
primary cells isolated in the laboratory. These cells have been cultured
in standard medium supplemented with 10% serum. Serum is inhibitory to
these cells and the lab assistant has to develop a medium formulation
with minimal or no animal-derived component that can still maintain cell
characteristics. She has 6 months to complete her project and needs to
focus on the critical factors affecting cell growth and differentiation.
- Before progressing to full-scale commercial manufacturing, a production
engineer wants to ensure that the procedure for the production of a viral
vaccine is robust, i.e. not subject to deviations. Four factors are known
to affect production independently, and specifications have been established
for each one during validation tests. The engineer however suspects that
some specification violations may be due to factor interactions. If so,
these factors may need tighter control than anticipated.
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