Delivery Challenges

The therapeutic application of biotechnology-based drug substances poses several problems, such as the low permeability across biological membranes due to the inherent physicochemical instability of biomacromolecules as well as their high molecular weight and polar surface characteristics. This implies that biotechnology-based pharmaceuticals for systemic treatment are administered parentally, although efforts are made to improve bioavailability via alternative routes of administration as for instance the nasal, pulmonary, and oral route (3-5). A crucial issue to consider is how to overcome these biological barriers, whether the drug delivery system is administered to a patient by

Source malarial Microbial or mammalian cells

Extracellular protein Removal ot cells

Concentration of extract

Cemrifugation/precipitation

Capture

Affinity or ion-exchange chromatography Intermediate purification Ion-exchange chromatography Hydrophobic interaction chromatography Polishing

Size-exclusion chromatography a.o Conditioning (buffer. pH. concentration adjustment)

intracellular protein Recovery of cells Cell breakage Removal of debris

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