Biomedical Engineering Reference
In-Depth Information
Leachables/Extractables
This controversy will be ended by the development of plastic films that are
inherently free from additives. In addition, through regulatory approval of
applications where products are mainly made using disposable systems, the
FDA/EMEA will establish the safety of plastic. Currently, no clear guidelines
exist from regulatory agencies, leaving a large burden on manufacturers.
This will be reduced by the agencies issuing specific guidelines for the use
of disposable systems in bioprocessing.
Multipurpose Disposable Bioreactors
The greatest hurdle in providing sufficient oxygen for the ever-higher
expressing cell lines has been removed by novel sparging systems to deliver
oxygen mass transfer capacity of 10 mmol/L/h (K
L
a = 50/h) when 50 × 10
6
cells/mL are cultivated. For microbial systems, like an
E. coli
fermentation
at 50 g/L dry cell weight, the required mass transfer capacity has to be 200
mmol/L/h (K
L
a > 800/h) or even higher. More advances will be made in the
use of disposable bags that will be available with integrated sensors and
equipped with connections for feed, inoculums, sampling, and with gas
inlet and exhaust gas filters.
In conclusion, the disposable technology of today will prove to be a “game
changer” in the field of bioprocessing, making it easier to develop new drugs
and to conduct research in the emerging field of stem cells and gene therapy.
The driving force behind this change will be the cost savings realized by the
industry in making this switch even though it may mean discarding a heavy
infrastructure of manufacturing biological drugs.
