Biochemical Engineering

Lecture #4 &5

BITS Pilani, K K Birla Goa Campus

Rec- Human Insulin- Glucose regulating hormone

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 Hormone produced by beta cell of pancreas
 Short peptide comprising of 51 amino acids
 Used in Diabetes treatment (Type I)

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Glucose regulating hormones

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VIVEK R BITS Pilani, K K Birla Goa Campus
Probiotics- digestive aid

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Live bacteria/ yeasts that are good for digestive system

 Irritable bowel syndrome

 Antibiotic therapy
 Digestive disorder

Two commonly used genus

Bifidobacteria sp.
Lactobacillus sp.

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Methanobrevibacter smithii in human guts responsible for methane production
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Digestion of grass by ruminant

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VIVEK R BITS Pilani, K K Birla Goa Campus
 Digestion of wood by termite

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Source: http://www.nature.com/nrmicro/journal/v12/n3/abs/nrmicro3182.html?foxtrotcallback=true BITS Pilani, K K Birla Goa Campus
Ampicillin- antibiotic

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A semi-synthetic derivative of penicillin

A broad spectrum antibiotic

used to prevent many different types
of
• infections
• Bladder infections,
• pneumonia,
• gonorrhea,
• meningitis, or
• infections of the stomach or
intestines.

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Vaccines- acquired immunity inducer

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Edward Jenner Caricature on Edward Jenner
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 Edward Jenner’s Vaccination procedure

James is inoculated
Scabs are collected James is unaffected
with cowpox pus from
from a small pox patient Protection is complete
Nelmes

Sarah Nelmes, a milkmaid James is inoculated

James falls ill with
Infected with cowpox with the scabs of
mild case of cowpox
small pox VIVEK R
Hepatitis B vaccine (recombinant) production process

BITS Pilani, K K Birla Goa Campus

Haziness reducing agent - Pectinase

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 Industrial products produced by biological process

Najafpour 2007 VIVEK R BITS Pilani, K K Birla Goa Campus

Recombinant therapeutics approved for marketing in India

S. Molecules Therapeutic indications

No.
1. Human insulin Diabetes
2. Erythropoietin Anemia
3. Hepatitis B vaccine Hepatitis B
(recombinant surface antigen based)
4. Human growth hormone Deficiency of growth hormone in children
5. Interleukin 2 Renal cell carcinoma
6. Interleukin 11 Thrombocytopenia
7. Granulocyte Colony Stimulating Factor Chemotherapy induced neutropenia
(GCSF)
8. Granulocyte Macrophage Colony Chemotherapy induced neutropenia
Stimulating Factor (GMCSF)

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9. Interferon-2a Chronic myeloid leukemia
10. Interferon-2b Chronic myeloid leukemia, Hepatitis B and
Hepatitis C
11. Interferon-g Chronic granulomatous disease and severe
malignant osteopetrosis
12. Streptokinase Acute myocardial infarction
13. Tissue Plasminogen Activator Acute myocardial infarction
14. Blood factor VIII Haemophilia type A
15. Follicle stimulating hormone Reproductive disorders
16. Teriparatide (Forteo) Osteoporosis
17. Drotrecogin (Xigris) alpha. Severe sepsis
18. Platelet Derived Growth Factor (PDGF) Bone marrow induction and osteoblasts
proliferation
19. Epidermal Growth factor (EGF) Mitogenesis and organ morphogenesis
20. Eptacogalpha (r-F VIIa) r-coagulation Haemorrhages, congenital or acquired
factor hemophilia
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 Bio-manufacturing process

Upstream Fermentation Downstream

Sterile Preparation Production in Purification

-medium fermentor
-Inoculum
-vessel etc.,

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VIVEK R BITS Pilani, K K Birla Goa Campus
VIVEK R BITS Pilani, K K Birla Goa Campus
VIVEK R BITS Pilani, K K Birla Goa Campus
VIVEK R BITS Pilani, K K Birla Goa Campus
VIVEK R BITS Pilani, K K Birla Goa Campus
Department of Biotechnology (DBT), under ministry of Science and Technology, estd 1986
Autonomous Institutes
• Centre for DNA Fingerprinting & Diagnostics, Hyderabad
• National Institute of Animal Biotechnology, Hyderabad
• National Centre for Cell Science, Pune
• National Brain Research Centre, Manesar
• Rajiv Gandhi Centre for Biotechnology, Thiruvananthapuram
• National Institute of Immunology Delhi
• Institute of Plant Genome Research Delhi
• Institute of Life Sciences, Bhubaneswar
• Institute of Bioresources and Sustainable Development Imphal
Public Sector Undertakings
• National Agri-Food Biotechnology Institute, Mohali
• Bharat Immunologicals and Biologicals Corporation limited , Bulandshahar
• Indian Vaccine Corporation Limited Delhi
• Biotech Consortium India Limited, New Delhi
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Council of Scientific and Industrial Research (CSIR) Laboratories Biological Sciences

1. Centre for Cellular and Molecular Biology (CCMB), Hyderabad

2. Central Drug Research Institute (CDRI), Lucknow
3. Central Food Technological Research Institute (CFTRI), Mysore
4. Central Institute of Medicinal & Aromatic Plants (CIMAP), Lucknow
5. Indian Institute of Chemical Biology (IICB), Calcutta
6. Institute of Microbial Technology (IMT), Chandigarh
7. Indian Institute of Toxicology Research (IITR), Lucknow
8. National Botanical Research Institute (NBRI), Lucknow
9. Regional Research Laboratory (RRLJM), Jammu Tawi
10.Institute of Himalayan Bioresource Technolonogy (IHBT), Palampur

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BITS Birac Bionest –startup incubator (Biotechnology)

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Bio-production Industrial environment

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 Biosafety levels (BSL)

High Ebola virus

BSL 4

Moderate Mycobacterium tuberculosis

BSL 3

Low Measles virus

BSL 2

No BSL 1 Baker’s yeast

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BSL 1

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BSL 2

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BSL 3
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BSL 4
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 INHALABLE INSULIN PRODUCTION

https://www.crbusa.com/inhalable-insulin-project
 INHALABLE INSULIN: FERMENTORS

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https://www.crbusa.com/inhalable-insulin-project
 INHALABLE INSULIN: PURIFICATION UNITS

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https://www.crbusa.com/inhalable-insulin-project
 INHALABLE INSULIN: FORMULATION SECTION

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https://www.crbusa.com/inhalable-insulin-project
 Biotechnology Regulatory Authority of India (BRAI)

A regulatory body in India for uses of biotechnology products

including genetically modified organisms (GMOs).

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 Regulatory constraints in bioprocesses

FDA approval for both product and process

Three phases of clinical trials

From discovery to preclinical trials (animal studies) – 6.5 to 7 years

 Phase 1: testing safety in 20- 80 volunteers – 1 year

 Phase 2: efficacy and side effects in 100-300 volunteers (2 years)

 Phase 3: efficacy and side effects in varied population in 1000-3000 patients – 3 years

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