Biomedical Engineering Reference
In-Depth Information
adopt disposable systems. As long as the cost of changeover, cleaning valida-
tion, and compliance stays within reach, few manufacturers have an incen-
tive to mothball their stainless steel systems. However, as biogeneric drugs
begin entering the market, innovators will feel a real pinch and may adopt
the new way of manufacturing these drugs.
High-Expression Cell Lines
Many advances have been made in the titer obtained from animal cell cul-
tures. The magical level of 10 g/L is being reached, which is what is needed
to cut down the entire production operation in the upstream area. As a
result, future upstream facilities will shrink substantially. Many facilities
with designs based on 1 to 2 g/L titers will become obsolete as they would
bring a disconnect between upstream and downstream processing. A 2,000
L disposable bioreactor would be able to do what a 20,000 L bioreactor of the
past did. The size of bioreactors will inevitably shrink.
Flexible Factories
To anticipate future needs, manufacturing facilities need to move away
from large-scale, stick-built-fixed configuration designs to those that will
be less expensive and easier to build. Clean spaces will be optimized and
can easily be expanded and contracted. Interiors will be highly configu-
rable with utility panels and portable equipment to accommodate product
mixes and different production volumes. Innovations are also needed to
comply with the newer or upcoming requirements of the FDA and EMEA
in ensuring viral clearance, and this will require adopting unorthodox
heating, ventilation, and air conditioning (HVAC) systems instead of
physically separating the activities. A bioprocess facility with this mobile
warehouse design and disposable applications will offer several competi-
tive advantages for manufacturing. Quick construction and setup is par-
ticularly advantageous for vaccine production in response to pandemic
or bioterrorist threats at desirable geographical locations. Because capital
investment is relatively lower than for conventional facilities (and opera-
tions are also simpler with the application of disposable technologies),
lower fixed costs and less labor will be required to maintain and operate
these new facilities.
 
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