The 2013 BIO International Convention
takes place this month in Chicago, Illinois. Since cell-culture media are such
a critical component for the manufacture of biologics, the fourth issue of The Pharmaceutical Sciences,
Manufacturing & Marketplace Report includes a
roundtable discussion on this subject, with comments on trends in media
development from leading manufacturers.
With respect to media for protein
expression, the focus, it seems, has moved from increasing protein expression
yields to ensuring product quality by gaining better control over the makeup of
the cell- culture media. That means closer scrutiny of raw materials and
investigation of the effect of each of the numerous media components on cell
performance, which has led to increased investment in and development of
characterization techniques.
Of course, there is also growing demand
for culture media used for the production of therapeutic cells. The media
needed in these applications must be carefully designed to encourage
proliferation without specialization until the desired time. Isolation of the
cells, which tend to be fragile, requires much gentler downstream processing
conditions.
The use of chemically defined media
seems to offer a solution in both applications. Manufacturers can characterize
individual raw materials and ensure that they meet specifications and perform
as needed. The key will be the ability
to achieve accurate characterizations and develop methods that allow
researchers to make connections between specific component properties and
certain cell performance parameters.
Are there technologies available today
that can achieve these goals, or do existing characterization techniques
require modifications to be of maximum use? How do you evaluate the performance
of your cell culture media? What do you expect from your media supplier along
these lines?
We’d like your opinion. And suggestions
of topics related to biologic API manufacture that you don’t believe receive
the attention they should. Think about writing a guest blog – I welcome your
input.
Look for the fourth issue of The Pharmaceutical Sciences,
Manufacturing & Marketplace Report this week.
If you haven’t signed up to receive it yet, take the opportunity right now.
Just click here.
Cynthia
A. Challener, PhD
Editor
The Pharmaceutical Sciences,
Manufacturing & Marketplace Report
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