| |
Back
Culture Improvement Cases That Would
Benefit from Design of Experiment
- 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 finding
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.
Back to top
|