Biomedical Engineering Reference
In-Depth Information
Downstream Processing
Molecule-specific facilities and equipment will prove to be more cost-effective
than using a disposable system. The current attempts to make the tubing in
chromatography systems disposable will not be needed if the equipment is
dedicated to each molecule. With the development of better resins and the
partial purification achieved in the bioreactor, it will be more cost-effective to
dedicate equipment to molecules.
Closed Systems
Completely closed systems wherein buffers, media, protein capture, and
initial purification remain enclosed will allow the use of environment con-
ditions that are less expensive to maintain, for example, the use of a 500K
facility instead of a 100K facility currently recommended for upstream
processing.
Molecule-Specific Facilities
Molecule-specific facilities will become the norm to reduce the largest bur-
den of cross-contamination validation. This will become possible as the capi-
tal cost of establishing a facility reduces substantially. The focus will be on
smaller facilities that operate in a self-contained environment.
Max-Dispo Concept
While the use of disposable components has obvious advantages, with mole-
cule-specific facilities and substantially reduced sizes of production systems,
disposable items will be used where needed and not necessarily just because
disposable items are available. For example, buffer preparation is a noncon-
taminating exercise, and there is no need to use disposable stirrers: just the
containers need to be disposable. The industry will evolve into integrating a
realistic approach regarding what should be disposable.
