Biomedical Engineering Reference
In-Depth Information
Fermentation
If protein is expressed
extracellularly
If protein is expressed
intracellularly
Removal of cells from media
(centrifugation or filtration)
Recovery of producer cells
(centrifugation or filtration)
Cellular disruption
(homogenization)
Removal of
cellular debris
(centrifugation
or filtration)
Concentration of product-containing
extracellular media (ultrafiltration or
precipitation)
Initial purification/concentration
(ultrafiltration/ion exchange or
precipitation)
Chromatographic
purification; usually
2-4 chromatographic
steps
Adjustment of
potency and addition
of excipients
Sterile filtration
and aseptic filling
Freeze drying
Liquid preparation
Powder preparation
Sealing of final product
container, labelling and packing
Figure 6.1 Overview of a generalized downstream processing procedure employed to produce a fi nished-
product (protein) biopharmaceutical. QC also plays a prominent role in downstream processing. Qualty control
personnel collect product samples during/after each stage of processing. These samples are analysed to en-
sure that various in-process specifi cations are met. In this way, the production process is tightly controlled
at each stage
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