3. •Treatment of culture broth after fermentation to
concentrate and purify products.
•Recovery and purification of biosynthetic products
•Recycling of salvageable components and the
proper treatment and disposal of waste.
4. Why Downstream Processing?
• An essential step in the manufacture of pharmaceuticals.
• Includes:
Antibiotics,
Hormones (e.g. insulin and human growth hormone),
Antibodies (e.g. infliximab and abciximab) and vaccines;
Antibodies and enzymes used in diagnostics;
Industrial enzymes; and
Natural fragrance and
Flavor compounds.
9. a) Isolation steps are designed to remove it (i.e.dialysis)
b) Reducing the volume
c) Concentrating the product.
d) Liquid –liquid extraction{adsorption, ultrafiltration, and
precipitation.
11. • Done to separate those contaminants that resemble the
product very closely in physical and chemical properties.
• Expensive to carry out
• Require sensitive and sophisticated equipment
• Significant fraction of the entire downstream processing
expenditure.
• Examples of operations include affinity, size exclusion,
reversed phase chromatography,crystallization and fractional
precipitation.
14. PRODUCT POLISHING
. The final step that ends with packaging of the
product in a form that is stable, easily
transportable and convenient.
Typical unit operations are :-
. Crystallization
. Desiccation
. Lyophilization
. Spray Drying (May include: Sterilization of the
product ) .
. Remove or deactivate trace contaminants which
. The final step that ends with packaging of the product in a form that
is stable, easily transportable and convenient.
Typical unit operations are :-
. Crystallization
. Desiccation
. Lyophilization
. Spray Drying (May include: Sterilization of the product ) .
. Remove or deactivate trace contaminants which might compromise
product safety viruses or Depyrogenation .
15. CRYSTALLIZATION
• Crystallization is the (natural or artificial) process by
which a solid forms, where the atoms or molecules
are highly organized into a structure known as
a crystal .
. Chemical solid-liquid separation technique, in which
mass transfer of a solute from the liquid solution to a
pure solid Crystalline phase.
16. DESICCATION
.Desiccation is the state of extreme dryness, or the
process of extreme drying .
. A desiccant is a hygroscopic (attracts and holds water)
substance that induces or sustains such a state in its
local vicinity in a moderately sealed container .
18. . Spray drying is a method of producing a dry powder from
a liquid or slurry by rapidly drying with a hot gas.
.This is the preferred method of drying of many thermally-
sensitive materials such as foods and pharmaceuticals .