Monoclonal Antibody Production (Upstream, Downstream and Process Economics Evaluation)

1. Bioprocess Equipment Design
and Economics
(BTMT-601)
Submitted By:-
Ilika Kaushik
(19PBT004)
M.Tech Biotechnology,
3rd Sem,
SoBT, GBU.
Submitted To:-
Dr. Barkha Singhal
Asst. Professor
SoBt, GBU

2. topic:-
Monoclonal Antibody Production
(Upstream, Downstream and
Process Economics Evaluation)

3. Introduction
• An antibody made by cloning a unique white blood
cell.
• Have monovalent affinity, binding only to the
same epitope
• Bispecific monoclonal antibodies can also be
engineered, by increasing the therapeutic targets of
one single monoclonal antibody to two epitopes.

4. History
In 20th
century immunologist Paul
Ehrlich, proposed the idea of a
medical Zauberkugel, a
"magic bullet".
He and Élie
Metchnikoff received the
1908 Nobel Prize for
Physiology or Medicine for
this work.
Production of monoclonal
antibodies involving human–
mouse hybrid cells was first
described by Jerrold
Schwaber in 1973.
In 1975, Georges
Köhler and César
Milstein succeeded in making
fusions of myeloma cell lines
with B cells to
create hybridomas that could
produce antibodies
They and Niels Kaj
Jerne shared the Nobel Prize
in Physiology or Medicine in
1984 for the discovery.
In 1988, Greg Winter and his
team pioneered the techniques
to humanize monoclonal
antibodies
In 2018, James P.
Allison and Tasuku
Honjo received the Nobel
Prize in Physiology or
Medicine

5. Production
World demand was of few hundred
kgs/year
This demand would exceed over
100kgs/year.
Ascites, STRs and Hollow-Fibre
Bioreactors are currently used
STRs are generally used.
Operated under Batch, Fed-Batch or
Perfusion Mode.

6. Production Simulation, Outline and
Flowchart

7. Upstream Process-Bioreaction Section

8. Downstream Process- Recovery Section

9. Downstream Process- Purification
Section

10. Material Balances (kg/batch)

11. Process Scheduling

12. Economic Evaluation

13. Breakdown of Manufacturing Costs

14. Sensitivity Analysis

15. Applications
Diagnostic Tests
• Western Blot and ImmunoDot Blot tests.
• Immunohistochemistry and Immunofluorescence
Analytic and Chemical Uses
• Purification of target compounds.
• Using Immunoprecipitation method.
Therapeutic Uses
• Cancer treatment.
• Treatment of autoimmune disease

16. Side Effects
Common
• Dizziness
• Headaches
• Allergies
• Diarrhoea
• Cough
• Fever
• Itching
• Back Pain
• Fatigue
• Loss of appetite
• Insomnia
• Constipation
Serious
• Anaphylaxis
• Bleeding
• Arterial and Venal Blood Clots
• Autoimmune Thyroiditis
• Hypothyroidism
• Hepatitis
• Heart failure
• Cancer
• Anaemia
• Decrease in WBCs
• Stomatitis
• Enterocolitis
• Gastrointestinal Perforation
• Mucositis

17. References
Bioprocess
Design by
Demetri
Petrides.
Wikipedia