Biotechnology, scope, groups of organisms used biotechnology tools, red biotechnology, biologics:products of biotechnology,advantages and limitations of biotechnology, pharmaceuticals vs biologics, rDNA technology, manufacture of biologics, therapeutic biologics, recombinant vaccines, marketed biologics, biosimilars: Indian scenario

1. Biologics: Wonders of
Biotechnology
Presented by:
Dixita Jain
(Roll No.: 20101915017)
Under the Guidance of:
Dr. Nityananda Mondal
(Assoc. Prof., BCDA College of
Pharmacy and Technology)

2. ‘Biotechnology’ term coined by
Karl Ereky (Hungarian agricultural engineer) , 1917
European Federation of
Biotechnology
Defines Biotechnology as “the
integration of natural science and
organisms, cells, parts thereof, and
molecular analogues for products
and services.”
Biotechnology: The science which
deals with the techniques of using
living organisms or enzymes from
organisms to produce products and
processes useful to humans.
Modern biotechnology plays a crucial
role both in elucidation of the
molecular causes of disease and in
the development of new diagnostic
methods and better targeted drugs.

3. Scope of
Biotechnology
01
02
Biotechnology
in Other Areas
Biotechnology
in Medicine
Red Biotechnology:
Application of of biotechnological
processes and products in the field of
medicine. For e.g.: Gene therapy, Gene
cloning, Biologics etc
.
Green Biotechnology:
Application of biotechnology in
Agriculture for advanced and improved
yield. For e.g.: Bt Cotton, Bt rice etc.
:
Application of Biotechnology in
industrial processes.
Blue Biotechnology:
Marine and aquatic applications of
Biotechnology.
In recent years, the biotech industry has
been associated with:
 high efficiency production processes,
 low manpower,
 environmentally-friendly industry,
 low energy consumption and reduced
emission of greenhouse gases

4. Current biotechnological processes
essentially involve five different groups of
organisms:
e.g. Saccharomyces cerevisiae, Pichia and
Hansenula, Trichoderma and Aspergilli.
Fungi
e.g. tobacco plant, rape and transgenic potatoes
Plants
e.g. Spodoptra frugiperda
Insects
e.g. Escherichia coli, Pseudomonas spp, Erwenia
herbícola, Lactococcus lactis and Bacillus subtilis
Bacteria
e.g. Chinese hamster ovary cells (CHO), baby
hamster kidney cells (BHK) and transgenic
animals
Mammals
tobacco plant
Escherichia coli
Spodoptra frugiperda
Chinese hamster ovary cells
S. cerevisiae

5. Avenues of Red Biotechnology
Therapeutic proteins and
Vaccines
Recombinant Enzymes, Hormones,
Growth Factors and Vaccines are
available which are safer, more
effective and better accepted by
the body tissues.
Diagnostics
Biotechnological processes
and products (lab-kits) have
made possible molecular
diagnosis of diseases using
ELISA, PCR, Blotting
techniques etc.
.
Therapeutic antibodies
It is possible to insert all
the human genes required to
produce antibodies into laboratory
animals that are structurally identical
to their natural counterparts in the
human body.
The process in which a faulty
gene is removed or replaced
with its healthy copy to restore
the normal function of that
gene
Gene Therapy
Biologics

6. Biologics
Biologics are
medical drugs
produced
using
biotechnology
These protein-based drugs produced by finding a gene that
codes for it and cloning the gene into a system where large
quantities of that protein can be made.
They are proteins (including antibodies), nucleic acids (DNA, RNA or
antisense oligonucleotides) used for therapeutic or in vivo diagnostic
purposes, and are produced by means other than direct extraction from a
native (non-engineered) biological source
Characteristics:
Come from a diverse source: microbes,
plant or animal cells
Much more complicated than other
drugs
Strongly resemble endogenous
proteins, breakdown is predictable for
most of the part.
.
The first such substance approved for therapeutic use
was recombinant human insulin.
1976
Herbert Boyer and Robert Swanson found Genentech,
the first modern biotechnology company.

7. Biologics: Advantages and Limitations
B
AA
B
C C
Advantages
Limitations
foreign proteins
may be interpreted by
the immune system as
a sign of infection, may
elicit allergic reactions.
Offer novel approaches to disease
management, due to their ability to
interfere with specific processes
which cannot be targeted by
conventional molecules.
Interference and dangerous
interactions with other drugs as
well as side effects are rare.
Susceptible to light
and temperature
changes. Unstable
and unpredictable
once formulated.
Take a lot of work to purify,
process, and produce.
Expensive procedures.
Have a strong affinity for a
specific target molecule, do not
engage in nonspecific
reactions in the body.

8. Biologics Vs Conventional Pharmaceutical Drugs
Small molecules of known Chemical
Structure
finished drug can be analyzed to
determine all its various components
by testing methods available.
manufactured through chemical
synthesis by combining specific
ingredients
Process differences are easy to
detect and rectify.
Large, Complex or mixture of molecules
Difficult, to characterize by testing methods
available in the laboratory, components of a
finished biologic may be unknown.
Produced in living systems, viz.
microorganism, or plant or animal cells
Sensitive to very minor changes in
the manufacturing process.
VS
Biologics Drugs

9. Recombinant DNA
Technology
Recombinant DNA Technology is the joining together
of DNA molecules from two different species that are
inserted into a host organism to produce new genetic
combinations .
The key tools used in rDNA technology are:
Enzymes:
Restriction endonucleases, DNA ligase, DNA
polymerase, Alkaline phosphatase
Cloning Vectors: Plasmids, Cosmids,
Bacteriophages, YACs, BACs
A
B
C
D
Selectable Markers
Competent Host

10. Recombinant DNA Technology
1
A
B
C
D
Isolation of DNA
Cutting Of DNA By Restriction Enzymes
Joining Of DNA by DNA Ligase
DNAAmplification using PCR
Insertion of Recombinant DNA into Host cells
Downstream Processing
The process of separation
and purification of a
biosynthetic product, along
with their formulation with
suitable preservatives

11. Manufacture of Biologics
The manufacture of biologics is a highly demanding process. They are made using intricate living systems that
require very precise conditions in order to make consistent products. Slight
changes in temperature or other factors can impact the final
product and affect how it works in patients The manufacturing process consists of the following main steps:
Isolating and purifying the
protein
Filtering technologies are used to
isolate and purify the proteins
based on their size, molecular
weight, and electrical charge
04
Preparing the biologic for
use by patients
The purified protein is typically
mixed with a sterile solution that
can be injected or infused, and fill
up in vials and syringes
.
05
Marketing
Label the vials or syringes,
package them, and make them
available to physicians and
patients.
06
Producing the master cell line
containing desired gene
Cells are placed in Petri dishes or
flasks containing a liquid broth with
the nutrients that cells require for
growth
01
Growing a large numbers
of cells producing the
protein
Cells are sequentially transferred
to larger vessels, called
bioreactors
02
03
Identification and Isolation of
Gene of Interest
Cells containing the gene of interest
are isolated using Recombinant DNA
technology.

12. Therapeutic Biologics
Recombinant
Factor VIII
used in the
treatment of
hemophilia A
Recombinant
Factor IX
used in the
treatment of
hemophilia B.
(produced in
CHO)
Recombinant
human
erythropoietin
(Procrit®,
Epogen®,
Eprex®)
alpha (produced
in CHO), beta
(produced in
CHO) and
gamma
(produced in
BHK).
Recombinant
Interleukins
(Proleucina®)
and blockers
(Arcalyst®)
Recombinant
interferon
(Intron-A®,
Roferon-A®)
Recombinant
dornase alpha
produced by
CHO cells,
used in the
treatment of
patients with
cystic fibrosis
(Pulmozyme®)
Blood Factors Hormones Growth Factors
Recombinant
human insulin
(Humulin®,
Novolin®,
Velosulin®)
Recombinant
human growth
hormone,
(Nutropin®,
Humatrope® and
Serostin®)
Cytokines Enzymes

13. Recombinant Vaccines
The growing resistance to the existing
arsenal of antibiotics increases the
need to develop vaccines against
common bacterial infections
Despite the success of conventional
vaccines, there are still many
infectious diseases and other chronic
diseases against which no effective
vaccine exists
Conventionally produced vaccines are
generally harmless, some of them
may, rarely, contain infectious
contaminants. Vaccines whose active
ingredients are recombinant antigens
do not carry this slight risk.

14. World of Recombinant Vaccines
Cancerous
lesions in
the genital
area
Meningo-
coccal
disease
Pandemic
H1N1 virus
Combination
Vaccines
Cervical
Dystonia
seasonal
influenza
virus Myobloc®, Botox®
Focetria®, Pandemrix®, Celvapan®
.
Menveo® ,Prevnar13®
Gardasil ®, Cervarix®
Fluarix®, Istivac®, Fluzone ®, FluMist®,
Agriflu®, Dukoral®
Infanrix Penta®, Ambirix®, Twinrix®

15. Marketed Biotech Drugs
Glioblastoma, Metastatic colorectal
cancer, Non–small cell lung cancer,
Metastatic kidney cancer, Advanced
cervical cancer, Platinum-resistant
ovarian cancer.
AVASTIN® by Roche
Rheumatoid arthritis Polyarticular
juvenile idiopathic arthritis
Psoriatic arthritis Ankylosing
spondylitis Plaque psoriasis
ENBREL® by Amgen
Rheumatoid arthritis Non-Hodgkin
lymphoma (NHL) Chronic lymphocytic
leukemia (CLL) Granulomatosis with
polyangiitis Microscopic polyangiitis
RITUXAN® by Biogen Roche
Rheumatoid arthritis, Polyarticular juvenile
idiopathic arthritis, Psoriatic arthritis Plaque
psoriasis Crohn's disease Ulcerative colitis
Ankylosing spondylitis
HUMIRA® by AbbVie
USFDA
approved
Biologics
Diabetes mellitus
LANTUS® by Sanofi
Breast cancer,
Metastatic stomach/GEJ cancer
HERCEPTIN® by Roche
Pneumococcal pneumonia
PREVNAR® by Pfizer
Rheumatoid arthritis Psoriatic arthritis Crohn's
disease Ulcerative colitis Chronic plaque
psoriasis
REMICADE® by Johnson & Johnson

16. Biosimilars: Indian Scenario
.
A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that
is almost an identical copy of an original product that is manufactured by a different company
.India (CDSCO) Definition: Similar biologics- A biological product/
drug produced by genetic engineering techniques and claimed to
be “similar” in terms of safety, efficacy and quality to a reference
biologic, which has been granted a marketing authorization in India
by DCGI on the basis of a complete dossier, and with a history of
safe use in India
India shares 75% of biosimilar market. First biosimilar was
approved and marketed in India for a hepatitis B in 2000. In
recent years more than 50 biopharmaceutical products
have been approved for marketing in India, with more than
half of them being biosimilars

17. Biosimilars marketed
in India:
Reliance Life Sciences (Mumbai):
ReliPoietin: Recombinant erythropoietin
ReliGrast: Recopmbinant G-CSF
ReliFeron: Recombinat Interferon Alpha-2b
Biocon (Bangalore):
Eripro: Recombinant human erythropoietin
Nufil: Filgrastim (recombinant granulocyte- macrophage
Colony Stimulating factor, G-CSF)
Myokinase: Recombinant Streptokinase
Dr. Reddy’s Laboratories:
Reditux: Biosimilar rituximab
Grafeel: Filgrastim (granulocyte- macrophage Colony
Stimulating factor, G-CSF)
Cresp: Recombinant erythropoietin (darbepoietin alfa)

18. Conclusion:
Over the past few decades biotechnology – sometimes
described as the oldest profession in the world – has
evolved into a modern technology without which medical
progress would be scarcely imaginable. Modern
biotechnology plays a crucial role both in the elucidation
of the molecular causes of disease and in the
development of new diagnostic methods and better
targeted drugs. These developments have led to the birth
of a new economic sector, the biotech industry,
associated mostly with small start-up
companies.
Although the benefits of using biotechnology are clearly
evident, a number of concerns and criticisms remain
regarding the use of some techniques and procedures,
albeit ethical, including the creation of complete copies of
living beings (cloning), or environmental, especially in the
production of varieties of genetically modified living
organisms, whose impact on natural ecosystems may
never be determined.

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Brazilian Journal of Pharmaceutical Sciences vol. 47, n. 2, apr./jun., 2011
ELDRED, B.E.; DEAN, A.J.; MCGUIRE, T.M.; NASH, A. Vaccine components and
constituents: responding to consumer concerns. MJA, v.184, n.4, p.170-175, 2006
MATHIAS BRÜGGEMEIER; DAVID PLAYFAIR (English translation); Biotechnology-new
directions in medicine, Published by: F. Hoffmann-La Roche Ltd Corporate Communications,
CH-4070 Basel, Switzerland
AVIDOR, Y.; MABJEESH, N. J.; Biotechnology and Drug Discovery: From Bench to
Bedside, Southern Medical Journal (C) 2003 Southern Medical Association, Volume 96(12),
December 2003, pp 1174-1186
DR ANITA M O’CONNOR; Introduction to biotech drugs, FOCUS, Regulatory Rapporteur –
Vol. 6, No 1, January 2009 (www.topra.com)

20. Thank You