ROLE OF DOWNSTREAM PROCESSES IN PURIFICATION OF

BIOPHARMACEUTICALS.

Biopharmaceuticals are medical drugs produced using biotechnology. They are proteins
(including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) used for
therapeutic or in vivo diagnostic purposes, and are produced by means other than direct
extraction from a native (non-engineered) biological source. A large number of
biopharmaceuticals are derived from animas, rest from plants and other micro-organisms.

Irrespective of the source of Biological platform used to manufacture, the first product is
always produced in a turbid, impure state. If the filter media predominantly contains
Dispersed solids and the filter media filters suspended solids, there would be a greater
number of impurities to tackle. This short note focusses on importance of DPT in purification
of biopharmaceuticals from plants. Although Downstream processes account for 80 percent
of the overall costs, they are imperative in a manufacturing process. Many strategies have
been developed to simplify DSP, e.g. fusing target proteins to elastin-like polypeptides so
they can be purified by inverse transition cycling, the heat precipitation of host cell proteins
(HCPs) and aqueous two-phase separation. [1]

However, cost is the main criteria in a downstream process. In order to decrease costs , filter
capacity can be increased. To improve filter capacity beyond the nominal optimum, a broad
range of flocculants can be put into use. Owing to the high molecular mass of flocculants, the
filter capacity is automatically increased. The most effective flocculants change the particle
size distribution, which means that the filter area and retention rating must be adapted to
match the new feed stream conditions to achieve optimal filter capacity. Charged flocculants
use the concept of separation based on magnitude of charge. Flocculants therefore provide a
powerful, cost-effective solution for the development of efficient clarification steps during
the production of plant-derived biopharmaceutical proteins.

Reference:

[1] J. F. Buyel, R. M. Twyman, and R. Fischer, “Extraction and downstream processing of

plant-derived recombinant proteins,” Biotechnol. Adv., vol. 33, no. 6, pp. 902–913,
2015, doi: 10.1016/j.biotechadv.2015.04.010.