The document discusses various topics related to biotechnology and biomedicine from a global perspective. It provides an overview of biotechnology applications, major biotechnology companies worldwide with the US dominating, and achievements in biotechnology in countries like India, China, and the US. It also summarizes developments in areas like medical biotechnology, biomedical engineering, genomics, tissue engineering, and future directions of biomedicine involving concepts like lab-on-a-chip and nanosensors.

1. Gundu H. R. Rao, Emeritus Professor
Laboratory Medicine and Pathology, Anesthesiology, Lillehei
Heart Institute, Institute For Engineering Medicine, University
of Minnesota, Minneapolis, Minnesota USA.
gundurao9@gmail.com

2. Biotechnology and Biomedicine: Global Perspective
 Biotechnology is vast discipline, where integrated technology derived
from biological sources is applied for the development of various useful
consumer products.
 Biotechnology applications include, to name a few, agriculture, food and
beverage processing, forestry, environment, animal science, and
medicine.
 Some biotechnologies have been in use for thousands of years: For
example, every living organism is a biotechnology factory.
 Selected breeding of crops and animals. Foods and beverages using
microorganisms in nature: yogurt, bread, wine, beer etc.
 Some of the later BT developments include: Fermentations-antibiotics,
enzymes, amino acids, vitamins, poly-saccharides, gums, high fructose
syrups, vaccines.
 Biomedical Sciences on the other hand covers a wide range of subjects
from molecules to microbes to medicine, from body systems to medical
devices, and from human genome to health issues.

3. Global Biotechnology Companies
 There are more than 3000 BT companies worldwide. However,
reliable sources indicate that only about 100 out of these are
commercially viable.
 Over 70% of these BT companies are US Companies.
 Based on the revenues generated, only one from China and one
from India are listed in the top 100 BT companies in Wikipedia.
 The annual revenues generated by BT companies range from few
millions to over 15,000 million (Genzyme, USA).
 Biotechnology Industry is capital intensive. Like Pharmaceutical
Industry, needs cGLP and cGMP facilities to develop products for
the Global Market.

4. India’s Achievements in Biotechnology
 Post independent achievements include in the area of animal
sciences, agriculture sciences, medical sciences and Industry.
 Scientific developments of dairy industry resulted in increased
production of dairy products ( Number One Milk Producer)
 Scientific developments in Agriculture resulted in improved sugar
cane production ( Number One in Sugar production) as well as
production of Potatoes (Number two in the World).
 Industrial application of BT included production of antibiotics,
vaccines (60% of Global Vaccine), enzymes and fermentation
products (Ethanol: Number four in the World).
 Indian Vaccines are exported to 151 countries across Globe.
 Pharmaceutical Industry is 3rd largest. Herbal Products revenue is
greater than a billion dollars.

5. India’s Achievements in Biotechnology
 Priority areas in BT application include: Basic Biology,
biomedicine, bio-agriculture, bio-animal science, biodiversity,
bioenvironmental technologies, bio-safety.
 Government of India has established a Bio-tech park in Lucknow
and has approved the development of such parks in Karnataka,
Gujarat, Himachal Pradesh, Andhra Pradesh, and Kerala.
 UP is the home for 70% of the livestock population in the country
 In view of this importance the Institute of Human Genetics in the
Electronic City, Bangalore is studying the water buffalo genomics
under the leadership of Prof Sharath Chandra.

6. India’s Achievement in Biotechnology
 Various National Laboratories contributed to the success of
Biotechnology in India.
 National Dairy Institute, Karnal, Haryana (Original
Imperial Institute of Animal Husbandry and Dairying at
Bangalore, 1923)
 Indian Sugarcane Committee, Lucknow (1952) later Govt.
of India took it over.
 Potato Research Institute, Patna (1949) moved to
Simla(1956)
 Serum Research Institute of India, Pune (privately owned)

7. Biotechnology: Global (US) Perspective
 In the list of top 100 companies listed in Wikipedia more than
70% are US Companies.
 There are over 2000 BT companies in the USA and they offer
employment to over 60% of the worldwide workforce.
 Bioscience research and development is valued at 50 Billion in
annual revenues.
 There are more than 5.5 million scientists, engineers and
technicians supporting this platform.
 Implementing this technology in the USA has resulted in the
generation of over 110 billion dollars for the year 2010.
 The total estimated revenue of all sources of Biosciences exceeds
300 billion dollars this year in the USA.

8. Biotechnology Parks (Clusters)
 Directory of Biotek parks developed by Argos Biotech list
only 50 parks worldwide.
 The only park listed from India, is the Biotech Park in
Lucknow.
 William Hoffman’s Map of the Bio-clusters of the World list
only three sites in India, Biocon, Bangalore; Shantha Biotech,
Hyderabad and an unknown site in New Delhi.
 This world map of biotech clusters does not list the park in
Lucknow or the one in Pune.

9. Biotech Clusters
 Conceptually, the Biotech Clusters are, “geographic centers of
competing, complementary, or independent firms and industries
that do business with each other and/or have common needs for
talent, technology, funds and infrastructure”
 Critical factors for cluster development include: strong science
base, entrepreneurial culture, growing company base, ability to
attract key staff, availability of finance, premises and
infrastructure, business support services, presence of large
companies in related areas, skilled workforce, effective networks,
and supportive policy environment.
 Successful examples in the USA include, San Diego Metropolitan
area; Boston, Raleigh-Durham, NC; San Jose, CA and Washington
DC.

10. Biotechnology: Global (China/India) Perspective
 Globalization of the economy dictates improvement of science and
technology and competition for the world market.
 China which was isolated for decades from the rest of the world. Now it
has realized the advantages of international scientific collaborations.
 China has initiated exchange program with 152 countries and signed M o
U with 96 countries.
 China has 150 drugs in Clinical Trials. They have developed 20 Bio-Parks
and 500 Bio-enterprises and 300 Biomedicine facilities.
 India has only 1.5% of the share of over 2000 clinical Trials, although it
has over 8000 drug manufacturing units and is the 3rd largest producer
of generic drugs.
 India, which is also competing for the Global Market has 340 biotech
companies, of which 180 are in Bangalore.

11. Biotechnology: India Perspective
 Department of Biotechnology, Government of India describes the
BT growth in India as follows: “The Indian biotechnology sector
has, over the past decades, taken shape through a number of
scattered and sporadic academic and industrial initiatives”.
 Successful Biotech companies with significant revenues in India
are all privately owned by entrepreneurs: Biocon, Bangalore;
Shantha Biotech, Hyderabad; Glandpharma, Hyderabad; Dr
Reddy’s Laboratory, Hyderabad; Serum Research Institute of
India, Pune.
 DBT admits that the time is now ripe, to integrate these efforts
through a pragmatic National Biotechnology Development
Strategy like China.

12. Contributions of Modern Medicine : Genetics
 The Chicken Genome Sequencing Consortium is working on
sequencing Chicken genome for the improvement of poultry
products.
 University of Illinois has received a USD 10 million grant for
sequencing swine genome, to improve pork products.
 Institute of Human Genetics in Bangalore, has received several
million dollars worth of funds for sequencing buffalo genome to
improve dairy products.
 Researchers have developed ‘biotech pigs’ that produce high
levels of Omega 3 fatty acids, by inserting the “fat-1” gene that
increases the levels of this fatty acid.
 Omega 3 fatty acid-rich eggs are already available in the USA

13. Biotechnology and Biomedicine
 Medical Biotechnology is the largest component of Biotechnology
 Key products include; biological drugs, vaccines, in-vitro
diagnostics, Bio-markers and molecular markers, rDNA and
cDNA applications.
 Biotechnology derived medicines are valued at over 70 billion
dollars.
 Just a list of medical products developed by one company,
Genentech, USA, indicates the significance of this sector: Bio-
Oncology: Avastin for metastatic colo-rectal cancer, Herceptin
for HER-2 positive cancer, Rituxan, for non-Hodgkin's
lymphoma, Xolair for persistent asthma, Activase for heart
attack and stroke, TNKase for the same, Pulmozyme for cystic
fibrosis, CathfloActivase for increased blood flow.

14. Biotechnology: Biomedical Engineering
 In the area of biomedical engineering, cellular and molecular
therapies are gaining importance.
 Kyoto University researchers have developed engineering skills to
turn skin cells into pluripotent stem cells (iPS cells). These
genetically programmed cells behave like embryonic stem cells.
 When these programmed cells are transfused to mouse with blood
disorders, the transfused cells behave like bone marrow cells and
produce normal healthy blood cells.
 Cellular Dynamics International (CDI) of Wisconsin has been
manufacturing cardiomyocytes for in vitro studies.
 Narayana Nethralaya of Bangalore, is testing limbal cell
transplantation for the repair of retinal disorders.

15. Biomedicine: Genomics and Gene Editing
 Apart form the use of engineered cells for cellular and molecular
therapies, there is considerable interest in gene-editing
applications for therapeutic purposes.
 Researchers have used a novel method of “editing” the genome to
treat mice with hemophilia by replacing the defective gene with
one that promotes blood clotting.
 By engineering different zinc fingers and attaching them to a
gene-cutting enzyme, they have created tools that can snip the
genome at specific sites and repair the defective target gene
 After such a treatment, the mice with hemophilia produced
enough of blood clotting protein to speed clotting process.

16. Biomedicine: Tissue Engineering Applications
 At Center of Cardiovascular Repair, University of Minnesota, Prof
Doris Taylor and associates have created bio-artificial hearts using
a novel approach.
 Pig or Rat hearts are chemically stripped of all the cells and the
extracellular matrix is used as scaffold for tissue engineering using
isolated cardiomyocytes in a bio-reactor providing needed cues
like pressure and electrical stimulus.
 Genzyme of Cambridge, MA and Medtronic Inc of Minnesota,
have a huge federal grant for the development of an ongoing
phase-2 clinical trial investigating the use of cell therapy to repair
damaged heart.

17. Biomedicine: Bio-artificial Organs
 Another approach to address problems associated with organ
transplantation is to develop bio-artificial organs.
 Researchers at the University of Minnesota have been working on
such projects for several decades.
 A bio-engineering company from Minnesota (Excorp Medical Inc)
has developed a bio-artificial liver using genetically engineered
pig liver cells. The device has been approved as an orphan device
by the US FDA.
 An Indian Company based in Hyderabad has acquired the rights
to manufacture these in India. Basically pig liver cells are cultured
on a disposable scaffold and used similar to kidney dialysis, to
assist the sick liver to recover.

18. Biomedicine: Use of mRNA, rRNA, rDNA etc.
 Vascular diseases including Heart disease are triggered by inflammation of the
vessel wall.
 MIT researchers have developed techniques to curb inflammation by using
interference mRNA technology, which disrupts the flow of genetic
information from the cells nucleus to protein-building machinery.
 In an animal model they delivered strands of mRNA that turns down the
inflammatory response by blocking activity of a specific gene in white blood
cells called monocytes.
 Packaged in nano-particles made from liposome or lipoids, the micro RNA
successfully reduced inflammation in a mice model.
 The RNA snippets targeted CCR2 receptor, a protein on the surface of cells,
mice treated with this type of micro RNA showed much lower levels of
inflammation in atherosclerosis, cancer and faster recovery from heart attack.

19. Biomedical Technology: Cutting-Edge Research
 Biomedicine today is a multidisciplinary specialty
 Scripps Research Institute, CA researchers have developed a
method for predicting acute vascular events by monitoring the
circulating endothelial cells in the blood.
 According to them, the number of circulating endothelial cells
four times greater in patients with heart attacks than healthy
individuals.
 They used flow cytometer to follow the circulating cells as well as
to follow the morphology of these cells.
 Similar studies with appropriate biomarkers can be used to
monitor “at risk” patients for developing acute vascular events.

20. Biomedicine: Lab on a CHIP Approach
 Pharmacology on a CHIP was the dream of Pharmacologists
 MIT scientists have developed MicroCHIPS that are under clinical
trial for the treatment of osteoporosis. The CHIP senses the need
for the drug and delivers a controlled level of the drug
Tetraparatide.
 The MiniMed Paradigm, REAL-Time Revel System of Medtronic
Inc, Minnesota combines glucose sensor with an insulin pump to
achieve controlled drug delivery.
 Brain-computer Interface Team at Singapore has developed a
brain-computer interface, that offers hope for stroke rehabilitation
by nearly rewiring their damaged nerves in the brain (Hand-held
stimulators for pain control are available).

21. Biomedicine: Future Directions
 Introduction of the “Pill Camera”, a small oral capsule that can
video-record the images of gastrointestinal tract ushered new era
in biomedical imaging.
 MIT researchers are now taking this concept much further by
giving the capsule greater capabilities like treading for movement
and remote control for manipulations. Such modification will
open the door for advanced robotic surgical procedures.
 Developing “nanosensors” patrolling the blood stream for
detecting the first sign of an imminent acute vascular event like
heart attack or stroke, capable of releasing anti-clotting or anti-
platelet or anti-inflammatory drugs to stop it, would
revolutionize the areas of biomedicine and biomedical
technology.