Industrial Biotechnology

PILOT SCALE

A pilot scale is a small scale preliminary study conducted in order to evaluate feasibility, time,
cost, adverse events, and effect size (statistical variability). They are designed to predict an
appropriate sample size and improve upon the study design prior to performance of a full -
scale research project. Pilot studies, therefore, may not be appropriate for case studies. They
are frequently carried out before large-scale quantitative research, in order to avoid time and
money being wasted on an inefficiently designed project. About 1-12 liters of media is used in
pilot scale and all the conditions are calibrated as per laboratory scale. If the results are
satisfactory the process is practiced on industrial scale, otherwise not.

INDUSTRIAL SCALE

The approved process is then practiced on industrial scale for production of our desired
product in higher amount. All the conditions remain the same with exception of time which
increases as per media. 100-10,000 liters of media is processed at a single time in industries.

UPSTREAM PROCESSING

The upstream processing refers to the first step in which biomolecules are grown, usually by
bacterial or mammalian cell lines in bioreactors. When they reach the desired density (for
batch and fed batch cultures) they are harvested and moved to the downstream section of the
bioprocessing.

DOWNSTREAM PROCESSING

Downstream processing refers to the recovery and purification of biosynthetic products,

particularly pharmaceuticals, from natural sources such as animal or plant tissue
or fermentation broth. It also includes the recycling of salvageable components and the
proper treatment and disposal of waste. It is an essential step in the manufacture of
pharmaceuticals such as antibiotics, hormones (e.g. insulin and human growth hormone),
antibodies and vaccines; antibodies and enzymes used in diagnostics; industrial enzymes;
natural fragrance and flavor compounds. Downstream processing is usually considered a
specialized field in biochemical engineering. Downstream processing is accomplished in the
following steps.

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