IntelliCyt eBook - October 2017 - 28

Development & Optimization: The Dynamic Duo of Biomanufacturing * Strategic Cell-Line Development

development. Screening began with a focus on basic growth and productivity
characteristics, then assessed more complex attributes. All the way through,
cells were grown under conditions as similar as possible to those needed for
the eventual process. It was known, for example, that fed-batch conditions had
to be accommodated. Only after reducing the candidates to two host cell lines
and one vector did a full development program begin.
The take-home lesson: Use simple, straightforward screens early on to weed
out undesirable characteristics such as poor growth, unsuitability to process
conditions, and low productivity that subsequent lines are likely to inherit.
Thereafter, apply more detailed characterization-but only after the
likelihood of success is greatly improved.

Engineering Viruses Out

If you are to find a good host cell line and vector, you should, Fujifilm
Diosynth believes, examine multiple avenues and have a robust
screening technique.

| GENengnews.com

During the production of biologics, the contamination of commercial
bioreactors is a rare but devastating and costly event. Although infrequent,
viral infection of a bioreactor can be catastrophic for the manufacturer,
resulting in the loss of product, temporary withdrawal from the market, and
extensive clean-down costs. Contamination events can also have an impact
on patient safety and regulatory implications. Viruses can be introduced
into biologic manufacturing processes through a variety of routes including
contaminated raw materials, infected cell lines, or via environmental factors
during the manufacturing process.

http://www.GENengnews.com

IntelliCyt eBook - October 2017

Table of Contents for the Digital Edition of IntelliCyt eBook - October 2017