Most developments in biotechnology originated for their potential applications in health care. Contributions of biotechnology are more frequent, more notable and more rewarding in health sector.

1. IMPACT OF
BIOTECHNOLOGY
ON MEDICINE
ALEN SHAJI
P1914015

2. INTRODUCTION
 Most developments in biotechnology originated for their potential applications
in health care.
 Contributions of biotechnology are more frequent, more notable and more
rewarding in health sector.

3. CONTRIBUTIONS OF BIOTECHNOLOGY IN
THE FIELD OF HEALTH CARE
1. DISEASE PREVENTION – VACCINES.
2. DISEASE DETECTION / DISEASE DIAGNOSIS.
3. DETECTION OF GENETIC DISEASES.
4. DISEASE TREATMENT / THERAPEUTIC AGENTS.
5. CORRECTION OF GENETIC DISEASES / GENE THERAPY.
6. FERTILITY CONTROL.
7. FORENSIC MEDICINE / DNA FINGERPRINTING IN FORENSIC MEDICINE

4. 1. DISEASE PREVENTION – VACCINES
 Prevention of disease is the most convenient and effective approach to
health.
 It is achieved by vaccination or immunization using biological preparations
called vaccines.
 Vaccines provide protection against diseases for which effective cures are not
yet available.
 Vaccines should not be tumerogenic.
 Vaccines should not be toxic.
 Vaccines should not be pathogenic.
 Vaccines should be safe.

5.  Vaccines should have very low levels of side effects.
 Vaccines should not contaminate the environment.
 The technique of vaccination should be simple.
 Vaccines should be effective in producing long lasting humoral and cellular
immunities.
 Vaccine should be cheap.
 Vaccines should not cause problems in individuals with an impaired immune
system.
 Vaccines can be grouped into;
1. Conventional vaccines.
2. Purified antigen vaccines.
3. Recombinant vaccines.

6. 1. CONVENTIONAL VACCINES
 It consists of whole pathogenic organisms.
 They are of two types;
1. Live vaccines.
 Whole pathogenic organisms, which may live.
 Virulence is greately reduced – Attenuation.
 Most viral vaccines.
2. Inactivated vaccines.
 Whole pathogenic organisms, which may be killed.
 Most bacterial vaccines.
 Some viral vaccines.

7. LIMITATIONS OF CONVENTIONAL
VACCINES
 Live vaccines have to be used since killed pathogen vaccines are ineffective.
 Live vaccines are generally produced from cultured animal cells, hence
expensive tissue culture set up is essential.
 Conventional vaccines carry a variable risk of disease development due to the
occasional presence of active virus particle.
 In many cases, conventional vaccines are difficult to produce.

8. EXAMPLE;
1. Covaxin.
 Corona virus vaccine.
 It is an inactivated vaccine.
 Developed by Bharat Biotech International Ltd in association with ICMR and
NIV.
 It is developed with Whole-Virion Inactivated Vero Cell derived technology.
 They contain inactivated viruses, which cannot infect a person but still can
teach the immune system to prepare a defence mechanism against the active
virus.
 Ingredients in the Covaxin;
1. Whole-virion inactivated SARS-CoV-2 antigen – Strain: NIV-2020-770.
2. Aluminium hydroxide.
3. Imidazoquinolinone.
4. 2-phenoxyethanol.
5. Phosphate buffer.

9. 2. PURIFIED ANTIGEN VACCINES
 Purified antigens isolated from the concerned pathogens.
 These are non-recombinant.
 Since they do not contain the organism, the risk of pathogenicity is avoided.
 Cost is higher due to the steps involved in purification and vaccine
preparation.
 Polysaccharide vaccines.
 Isolated antigens are poorly immunogenic.

10. 3. RECOMBINANT VACCINES.
 A recombinant vaccine contains either a protein or a gene encoding of a
pathogen origin that is immunogenic and critical to the pathogen function.
 The vaccine is produced using recombinant DNA technology.
 The gene essential for the pathogen, is isolated, cloned and used for vaccine
production.

11. A. RECOMBINANT PROTEINS OR SUBUNIT
VACCINES
1. WHOLE PROTEIN MOLECULE
 Complete immunogenic proteins.
 Produced in GEMs cultured animal cells, possibly in insects and plants
 Steps involved in the development of a recombinant protein-based vaccine;
1. Identify a protein that is both immunogenic and critical for pathogen.
2. The gene encoding this protein is then identified and isolated.
3. The gene is integrated into a suitable vector.
4. This vector is introduced into a suitable host, where the protein is produced in
large quantities.
5. The protein is then isolated and purified from the host cells.
6. It is used for the preparation of vaccine.

12. 2. RECOMBINANT POLYPEPTIDE VACCINES
 The whole protein molecule is not necessary for immunogenicity.
 The immunogenic property is usually confined to a small portion of the
protein molecule.
 Example; The immunogenicity of coat protein of feline leukaemia virus / FLV
is due to a 14 amino acid long segment; this segment produced a partial
immunogenic response in guinea pigs.

13.  LIVE RECOMBINANT VACCINES.
 Genes encoding antigenic proteins will integrate into the attenuated vectors
(live vectors) which will then used for vaccination.

14. B. DNA VACCINES
 These are regarded as the third revolution in vaccines.
 The gene encoding the relevant immunogenic protein is isolated, cloned and
then integrated into a suitable expression vector.
 This preparation is introduced into the individual to be immunized.
 The gene is ultimately expressed in the vaccinated individual and the
immunogenic protein is expressed in sufficient quantities to invoke both
humoral and cell mediated immunities.

15. EXAMPLE;
1. Covishield.
 Corona virus vaccine.
 ChAdOx1 nCoV-19 Corona Virus Vaccine – Recombinant.
 It is prepared using the viral vector platform.
 Developed by Oxford-AstraZeneneca.
 Manufactured by the Serum Institute of India / SII.
 A chimpanzee adenovirus – ChAdOx – has been modified to enable it to carry the
COVID-19 spike protein into the cells of humans.
 Covishield is a monovalent vaccine composed of a single recombinant, replication-
deficient chimpanzee adenovirus (ChAdOx1) vector encoding the S glycoprotein of
SARS-Cov-2.
 The S glycoprotein of SARS-CoV-2 is expressed locally stimulating neutralizing
antibody and cellular immune responses.
 This cold virus is basically incapable of infecting the receiver but can very well
teach the immune system to prepare a mechanism against such viruses.
 Ingredients in the Covishield;
ChAdOx1 vector, L-Histidine, L-Histidine hydrochloride monohydrate, Magnesium
chloride hexahydrate, Polysorbate 80, Ethanol, Sucrose, Sodium chloride, Disodium
edetate dehydrate / EDTA, Water for injection.

16. 2. Sputnik V.
 Corona virus vaccine.
 The Russian vaccine which has been given emergency use authorization in
India.
 Sputnik V outshines both Covishield and Covaxin with 91.6% effectiveness
compared to Covishield’s nearly 90% and covaxin’s 81%.
 High effieciency with low side effects.
 The volume of Sputnik V vaccine production in India will increase and may
surpass 50 million doses per month with respect to the increase in the
production of Covaxin to 12 million doses a month.
 By using human adenoviral vector mechanism.
 Adenovirus vectors are genetically modified viruses of the regular flu that
cannot replicate in human body.
 Vaccine only contains genetic information of protein coat / spikes of SARS-
CoV-2.

17.  Sputnik V uses two different vectors – Ad5 and Ad26 (based on human
adenovirus serotypes).
 Different vectors are used in two separate shots or in two doses.
 Ad5 vector is used in first dose and Ad26 vector is used in second dose or vice
versa.
 Using the same adenovirus for the two doses could lead to the body
developing an immune response against the vector and destroying it when the
second dose is administered.
 Sputnik V generates a durable and longer lasting immune response by using
different vectors in two doses.
 Covishield only using the same vector for both shots / doses, so they are less
effective than Sputnik V.
 Ingredients in the Sputnik V;
Modified replication-defective adenovirus of Ad5 and Ad26 serotype modifies to
include the protein S-expressing gene of SARS-CoV-2, Tris-(hydroxymethyl)-
aminomethane, Sodium chloride, Sucrose, Magnesium chloride hexahydrate,
Disodium EDTA dehydrate, Polysorbate 80, Ethanol, Water for injection.

18. 2. DISEASE DETECTION / DISEASE
DIAGNOSIS
 Diagnostic approaches developed by biotechnology;
1. DNA/RNA Probes.
 Probes are small nucleotide sequences consisting of 15-20 nucleotide bases
used to detect the presence of complementary sequences in nucleic acid
samples.
 Both DNA and RNA are used as probes.
 Probes are being used in clinical diagnosis for the detection of microorganisms
in various samples.
 Probes can be prepared by either radioactively or nonradioactively labelled.
 They are highly specific.
 They are relatively rapid.
 They are much simpler.
 They are extremely powerful especially when combined with PCR; even a
single molecule in the test sample can be detected.

19.  Probes can be used as follows;
I. Hybridization.
II. Dot blot hybridization.
III. Southern blot hybridization.
IV. In situ hybridization.
V. Ligase Chain Reaction.
2. Monoclonal antibodies.
 A monoclonal antibody preparation is specific to a single antigenic determinant of
a single antigen.
 Monoclonal antibodies are employed for;
I. Classification of blood groups.
II. Clear and specific detection of pathogens.
III. A very clear and accurate detection of cancers.
 The immunological assays generally employed for diagnostic purposes are
varied;
I. ELISA.
II. Immuno-PCR.

20. 3. DETECTION OF GENETIC DISEASES
 Identification of the genes responsible for genetic diseases is important.
 Gene identification is a prerequisite for gene therapy.
 The incidence of genetic diseases can be minimized by an early detection of
the afflicted fetuses and termination of such pregnancies and it involves;
I. Obtaining the foetal cells – Amniocentesis.
II. Detection of the defective gene.
III. Karyotype analysis.
IV. Enzyme assays.
V. RFLP analysis.
VI. Hybridization with oligonucleotide probes.
VII. Pedigree analysis.
VIII. STR linkage mapping.
IX. Northern hybridization / RT-PCR.
X. Zoo blot analysis.

21. 4. DISEASE TREATMENT / THERAPEUTIC
AGENTS
 Compounds that are used in treatment of diseases are obtained by;
1. Products from Non recombinant Organisms.
 Microorganisms.
 Plant cell cultures.
 Animal cell cultures.
2. Products from Recombinant Organisms.
 Genetically Engineered Microorganisms.
I. Production of Human Insulin / Humulin.
II. Production of Human Growth Hormone.
 Animal cell cultures.
 Transgenic plants.
3. Monoclonal Antibodies.
4. Artificial Tissues / Organs.
5. Therapeutic Oligonucleotides.

22. 5. CORRECTION OF GENETIC DISEASES /
GENE THERAPY
 Introduction of a normal functional gene into cells, which contains the
defective allele of concerned gene with the objective of correcting a genetic
disorder or an acquired disorder.
 Gene therapy is to cure any disease by the introduction of a cloned gene into
the patient.
 Requirements for gene therapy;
I. Identification of the gene that plays the key role in the development of a
genetic disorder.
II. Determination of the role of its product in health and disease.
III. Isolation and cloning of the gene.
IV. Development of an approach for gene therapy.

23.  Types of gene therapy;
I. Germ line gene therapy – The gem cells are modified by the introduction of
functional genes, which are ordinarily integrated into their genomes.
Therefore, the change due to therapy would be heritable and would be
passed on to later generations.
II. Somatic cell gene therapy – The gene is introduced only in somatic cells.
Expression of the introduced gene relieves/eliminates symptoms of the
disorder, but this effect is not heritable as it does not involve the germline.
 The gene delivery methods used for gene therapy can also be used for the
treatment of;
I. Cancer.
II. AIDS.
 Targeted Gene Transfer / Gene Targetting.
 Therapies to prevent transplantation rejection;
I. Immune suppressive therapy.

24. 6. FERTILITY CONTROL
 Vaccines to control fertility.
 Approaches to control fertility;
I. Vaccines against hCG / human chronic gonadotrophin.
II. Antibodies against follicle stimulating hormone / FSH.
III. Antibodies against vitamin carrier proteins.
 Eg; Saheli / Centchroman developed by Central Drug Research Institute /
CDRI, Lucknow.

25. 7. FORENSIC MEDICINE / DNA
FINGERPRINTING IN FORENSIC MEDICINE
 DNA fingerprinting / DNA profiling.
 The DNA is analysed on the basis;
1. RFLP / Restriction Fragment Length Polymorphism / Probe Hybridization.
I. Multi Locus Polymorphism Analysis / MLP.
II. Single Locus Polymorphism Analysis / SLP.
2. PCR / Polymerase Chain Reaction.
I. Short Tandem Repeats Analysis / STR.
II. Minisatellite Variant Repeat Analysis / MVR.

26. REFERENCE
I. A vaccine for all man kind, 2021, Russian Direct Investment Fund, Russia.
II. B.D. Singh, 2003, Biotechnology, Expanding Horizons, Kalyani Publishers, India.
III. ChAdOx1 nCoV-19 Corona Virus Vaccine, Recombinant, 2021, Serum Institute Of
India PVT.LTD., Pune.
IV. Chris Baraniuk, 2021, Covid-19; What do we know about Sputnik V and other
Russian vaccines?, The BMJ, Russia.
V. Fact sheet for vaccine recipients & care givers, Covaxin, 2021, Bharat Biotech
International Limited, Telangana.
VI. Fact sheet for vaccine recipient approved for restricted use in emergency
situation of ChAdOx1 nCoV-19 Corona Virus Vaccine, Recombinant, 2021, Serum
Institute Of India PVT.LTD., Pune.
VII. Michael Wink, 2011, An Introduction to Molecular Biotechnology, Wiley-Blackwell.
VIII. U. Satyanarayana, 2017, Biotechnology, Books & Allied (P) Ltd, India.

27. THANK YOU