Biomedical Engineering Reference
In-Depth Information
For capturing and polishing, a steel column is packed with a resin (station-
ary phase) comprising porous beads made of a polysaccharide, mineral, or
synthetic matrix conjugated to specific functional groups exploiting different
separative principles. The protein mixed with other components is loaded
onto the column slowly, and once it is bound to resin, the resin is eluted with
appropriate pH and electrolyte solutions to separate the target protein from
the mixture. The resin is cleaned and sanitized for repeated use that may
involve dozens or perhaps hundreds of cycles. To overcome the time needed to
pack resin and operate a column, several companies now offer columns such
as GE's ReadyToProcess systems for use in AKTA machines. GE offers a wide
range of resins and offers custom resins as well. These are high-performance
bioprocessing columns that come prepacked, prequalified, and presanitized.
Designed for seamless scalability, they deliver the same performance level
as available in conventional processing columns such as AxiChrom™ and
BPG™. Currently available with a range of BioProcess™ media in four dif-
ferent sizes—1, 2.5, 10, and 20 L—these are designed for purification of bio-
pharmaceuticals for clinical phase I and II studies. Depending on the scale of
operations, they can also be used for full-scale manufacturing, as well as for
preclinical studies. The columns can be used in a wide range of chromato-
graphic applications for separation of various compounds such as proteins,
endotoxins, DNA, plasmids, vaccines, and viruses.
Atoll offers the MediaScout MaxiChrom columns (
www.atoll-bio.com
),
which are disposable and totally incinerable; they come packed with Amberlite
XAD-4 as disposable item for removal of detergents after virus inactivation
during production in completely incinerable columns, and packed separation
media for virus removal during production in completely incinerable columns,
packed separation media for virus validation experiments during registra-
tion of a separation scheme in completely incinerable columns. MediaScout®
MaxiChrom 100-X columns (X = 50-300 mm) are professionally packed with
any resin or chromatography media chosen by the user, preferably with mate-
rials of particle size larger than 50 µm. They are individually flow-packed to
take into account the varying compressibility of each resin. Bed heights are
fixed to an accuracy of ±1 mm. MaxiChrom 100-X chromatography columns
are designed for preparative applications and/or scale-up development work.
The column hardware is fully incinerable, which makes the columns particu-
larly useful for single use in biopharmaceutical production.
The Case of Monoclonal Antibodies: A GE Report
To reduce costs and shorten time to market, the use of plug-and-play tech-
nology is increasing in process development as well as in later-stage produc-
