Biomedical Engineering Reference
In-Depth Information
products/batches, facilitates easy connection to and operation with pre-
packed ReadyToProcess™ columns and other process columns, and enables
scalable processes using UNICORN™ software.
Studies conducted using the foregoing ReadyToProcess system by GE to
manufacture a monoclonal antibody and comparing it with the traditional sys-
tem shows a reduction in the total process time by half from almost 50 hours to
24 hours. Most of the time savings comes from obviating interim validation of
equipment. The purity levels of the product obtained are generally comparable.
However, in this particular example, the cost of materials is substantially higher
when using the ReadyToProcess system; how much of it gets reduced by the
time savings would depend on the cost of time to the individual processor.
Step
ReadyToProcess
Traditional
% Time saving
Upstream
Wave Bioreactor
Stirred tank
0
Capture
ReadyToProcess
Protein A
AxiChrom 70 column
with Protein A
55
Buffer Exchange,
UF
ReadyToProcess
hollow fiber
cartridges
Kvick cassettes
55
Polishing
ReadyToProcess
prepacked column,
Capto
AxiCrom Capto
66
Formulation
ReadyToProcess
hollow fiber
cartridges
Kvick cassettes
30
While the foregoing example provides a very good view of the state of the
art today, there remain many hurdles to providing a true cost-effective sys-
tem. One way of achieving this goal would be to combine the upstream and
downstream processes, as suggested elsewhere in this topic.
The foregoing system, however, can be further modified by using Scilog's
single-use ultrafiltration system. The SciPure 200 (
www.scilog.com
) is a sin-
gle-use bioprocessing platform for the automation, optimization, and docu-
mentation of tangential flow filter (TFF) Applications. The system has been
designed to meet cGMP and 21 CFR Part 11 standards for data collection
and security as a stand-alone device with the ability to create and execute
discrete or batch operations for filling, concentration, diafiltration, and nor-
malized water permeability (NWP). User-selectable end points and alarms
enable hands-free operation and ensure safe, consistent process perfor-
mance. The patented proprietary technology enables the SciPure 200 system
to respond to sensor feedback and thus maintain the user-defined flows and
transmembrane pressure (TMP) simultaneously. All wetted flow-path mani-
fold components of the SciPure 200 are considered single-use consumables.
SciLog (
www.scilog.com
)
recently developed a fully automated, single-
use purification platform that purportedly improves downstream process-
ing efficiencies and may help cut costs. Other companies are developing
