Biomedical Engineering Reference
In-Depth Information
that is traditionally seen in stainless steel reactors, all at a fraction of the cost
of stainless steel reactors and 3D disposable bioreactors. In the future, most
bioreactors will be of the 2D type at least in the fields of drug development,
contract manufacturing organizations (CMOs), contact research organiza-
tions (CROs), research institutions, and small companies.
Scale-Up
While clinical supplies can be prepared on a smaller bioreactor, the man-
ufacturer wants to make sure that larger volumes will be available fully
scaled-up; this was not possible with the best-selling Wave Bioreactor as it
was limited to a size of 500 L and there were no options to go to higher vol-
umes. Since the Wave Bioreactor requires rocking the bag, the volume of 500
L was just about what the bag would take as stress; also moving half a ton
of liquid up and down required some heavy engineering. What Wave could
have done was to promote the use of multiple bioreactors in a chain to obtain
higher batch sizes, an idea that was recently innovated by MayaBio that used
the Wave Bioreactors to transform them into producing a high growth of
bacterial cultures. Since manufacturers must meet the CFR 21 definition of
a batch as being a homogenous system, it is possible to circulate the media
among several bags to qualify them as a single batch to reduce the cost of
testing several batches. In the future, this method will be widely used to
reduce the validation requirements for different size batches, and entails
only conducting mixing validation studies.
Cost
The current market of major disposable bioprocessing equipment is con-
trolled by a few giants: GE, Pall, Sartorius-Stedim, EMD Millipore, Thermo
Fisher Scientific, Xcellerex, and Saint-Gobain. A large number of small, spe-
cialized producers of equipment are filling the need of small-to-medium-
sized bioreactors. It is not surprising that many of the leaders are emulating
each other to stay competitive in terms of the choices available. However,
the cost of these integrated systems offered by GE, EMD Millipore, and
Sartorius-Stedim has become prohibitive for use on a small scale. Once the
equipment manufacturers realize that there is a large market to serve with
less expensive systems, the prices will fall. However, there will always be the
higher-end products for Big Pharma, which loves to spend big bucks. For the
rest of the world, there will be more reasonable choices.
