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BT SYllabus 1 Syllabus Mumbai University by munotes
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Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
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AC_________________
Item No. ____________
UNIVERSITY OF MUMBAI
Program : M.Sc. Biotechnology
Course : M.Sc. Biotechnology
Syllabus for Semester: III & IV
(Choice Based and Credit System with effect from the
Academic year 2020 -21)
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Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
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Cover Page
Date: Signature :
Name : Dr. Anuradha Majumdar (Dean, Science and Technology)
Dr. Archana Rath (Chairperson, Ad Hoc BOS in Biotechnology)
Sr.
No. Heading Particulars
1 Title of the Course M.Sc. (Biotechnology)
2 Eligibility for
Admission B.Sc. (Biotechnology)
3 Passing Marks 40%
4 Ordinances /
Regulations (if any) --
5 No. of Years / Semesters 2 years/ Four semesters
6 Level P.G. / U.G./ Diploma / Certificate
(Strike out which is not applicable)
7 Pattern Yearly / Semester
(Strike out which is not applicable)
8 Status New / Revised
(Strike out which is not applicable)
9 To be implemented from From Academic Year 2020 -2021
AC___________
Item No. ______
UNIVERSITY OF MUMBAI
Syllabus for Approval
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Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
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PREAMBLE
In recent years, there has been a paradigm shift in education in terms of course content and learning
outcomes. In keeping with it, t he Faculty of Science & Technology, University of Mumbai, has
taken a progressive step to align various programs under its purview with the current Higher
Education Policy of the Government of India. The present M.Sc. Biotechnology Second Year
(Semester III and IV) syllabus has been designed wi th the idea of incorporating outcome -based -
learning for fruitful engagement of learners. The syllabus has undergone several curriculum
revision exercise based on the remodeled M.Sc. Biotechnology Curriculum, May 2017, Department
of Biotechnology, Ministry of Science and Technology, Government of India. The revised syll abus
is an outcome of several rounds of deliberations, discussions , feedback and multiple brainstorming
sessions involving various contributors & stakeholders - academicians, researchers , industry experts
and students . Course Objectives and Course Outcomes have been clearly defined for each paper in
the syllabus to guide teachers in order to make learning process more effective. A lot of focus has
been given in the syllabus to cover latest developments in the area of bio technology and to equip
students with necessary knowledge and skills. Relevant papers to make students industry ready
have also been included. Attempts have been made to draft a robust, well defined syllabus keeping
in view the best learning outcome which shall enable students to pursue high quality research or
increase employability of the students. Online course component has been introduced in the
curriculum in keeping with the digital initiatives of MHRD to provide good quality self -learning
content thr ough MOOCs under SWAYAM and allied platforms.
It is hoped that the revised syllabus shall serve its objective of promoting outcome -based learning
to meet the changing needs of the biotechnology sector.
Dr. Anuradha Majumdar (Dean, Science and Technology)
Prof. Shivram Garje (Associate Dean, Science)
Dr. Archana Rath (Chairperson , Ad Hoc BOS in Biotechnology )
Dr. Deepali Karkhanis (Member)
Dr. Sneha Panvalkar (Member)
Dr. Seema Kokitkar (Member)
Dr. Tara Menon (Member)
Dr. Jayaprada R. Chunduri (Member)
Dr. Bhupendra Pushkar (Member)
Dr. Rajesh C . Patil (Member)
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Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
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MSc Biotechnology Course Structure
Semester III
Course code
Title Theory
/Practical Marks Credits Nos of
Lectures
/week
PSBT 301 Applied
virology
and
microbiolog
y Theory 100 4 1
PSBT 302 Environmen
tal
Biotechnolo
gy Theory 100 4 1
PSBT 303 Biologics and
Regulatory
Affairs
Theory 100 4 1
PSBT 304 Molecular
Enzymolog
y and
Enzyme
Technology Theory 100 4 1
PSBTP301
Practical I Practical 50 2 4
PSBTP302
Practical II Practical 50 2 4
PSBTP303
Practical III Practical 50 2 4
PSBTP304
Practical IV Practical 50 2 4
TOTAL 600 24
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Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
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MSc Biotechnology Course Structure
Semester IV
Course
code Title Theory
/Practical Mark
s Credits No. of
Lectures/
week
PSBT 401 Nanobiotechnology Theory 100 4 1
PSBT 402 OMICS & Systems
Biology Theory 100 4 1
PSBT 403 Drug Discovery &
Clinical Study Theory 100 4 1
PSBT 404 Scientific Writing &
Food Biotechnology Theory 100 4 1
PSBTP 401
Practical I Practical 50 2 4
PSBTP 402
Practical II Practical 50 2 4
PSBTP 403
&
PSBTP 404 Practical III & IV Practical 100 4 8
TOTAL 600 24
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Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
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Teaching pattern:
One (01) Credit would be of thirty -forty (30 -40) learning hours; of this, more than fifty per cent of
the time will be spent on classroom instructions including practical as prescribed by the University.
Rest of the time would be invested for assignments, projects, journal writing, case studies, library
work, industrial visits, attending seminars/workshops, preparations for examinations etc. would be
considered as notional hours. The present syllabus considers (60L as classroom teaching an d 15
lectures as Notional hours/ paper). Each lecture duration would be for 60 min. The names of the
reference books provided in the syllabus are for guidance purpose only. Students and faculty are
encouraged to explore additional reference books, online l ectures, videos, science journals for
latest/ additional information.
Scheme of Examinations:
(a) Internal assessment of 40 marks per course per semester should be conducted.
(b) External assessment of 60 marks per course per semester at the end of every semester
(c) Practical examination of 200 marks should be conducted at the end of every semester.
A. Semester III - Theory -Internal assessment (40%) -40 marks
Sr No Evaluation type Marks
1. Assignments that can include article writing, report writing, preparation of a
review, on any topic selected from each paper
30 OR
PowerPoint presentation on a topic from the syllabus or related to the
syllabus
Note: The student can submit only 2 assignments and give 2 PowerPoint
presentations per semester. Respective college/department can decide the
allocation.
2. a. Active participation in routine class instructional deliveries 05
b Overall conduct as a responsible student, w.r.t manners, skill in
articulation, leadership qualities demonstrated through organizing co -
curricular activities, etc. 05
Total Marks 40
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Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
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Semester IV - Theory -Internal assessment (40%) -40 marks
Sr.
No Evaluation type Marks
1. For PAPER 1 & 2
Assignments that can include article writing, report writing, preparation of a
review, on any topic selected from each paper
30 OR
PowerPoint presentation on a topic from the syllabus or related to the
syllabus
Note: The student can submit only 1 assignment and give 1 PowerPoint
presentations per semester. Respective college/department can decide the
allocation
FOR PAPER 3:
The students have to present a clinical case/trial study report.
2. a. Active participation in routine class instructional deliveries 05
b Overall conduct as a responsible student, w.r.t manners, skill in
articulation, leadership qualities demonstrated through organizing co -
curricular activities, etc. 05
Total Marks 40
Sr.
No Evaluation type Marks
3. FOR PAPER 4:
The internal assessment will comprise of the following :
a. Online course:
The student is expected to complete at least one online course relevant for
the subject from any of the appropriate reputed online platforms.
A proof of successful completion of the online course must be provided for
the award of marks. 20
b. Research Proposal:
The student is expected to submit a research proposal relevant to the subject. 20
Total Marks 40
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Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
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B. Theory -External examination -60%
Semester End Theory Assessment - 60 marks
The duration of this exam will be of 2.5 hours (150 minutes)
The theory question paper will have 5 questions each of 12 marks.
For each unit, there will be one question and the fifth will be based on all the four units.
The fifth question will have 6 sub -questions out of which the student has to attempt any 3.
All quest ions shall be compulsory with internal choice within the questions such that each
question will be set of 24 marks with options.
Practical Examination Evaluation scheme (50 marks per paper)
1. Practical Question 1 25
2. Practical Question 2 15
3. Journal 5
4. Viva Voce 5
OR
1. Practical Question 40
2. Journal 5
3. Viva Voce 5
Semester IV - Project Dissertation 100 Marks
For semester IV it is mandatory for students to undergo Hands -on Project training in an
established research laboratory or college laboratory for 4 -6 months; This should
involve one or more relevant instrumentation technique.
Thesis on the same to be eval uated by the guide alternatively by an internal examiner
for 50M based on the student’s performance, written matter and experimentation.
A certificate must be appended with the thesis.
The external examiner will assess for 50M as a Presentation during pr actical exams.
Marks allotted by Internal examiner would be scaled down if required as per university
guidelines.
A certified copy of the journal is essential to appear for the practical examination.
Note:
In case of any changes in the above -mentioned evaluation scheme, the chairperson of
examinations would provide the necessary details and the format.
The practical examinations at a center would be evaluated by one external examiner
assigned by the University and one internal examiner assigned by the c ollege/department.
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Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
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M.Sc. BIOTECHNOLOGY
SEMESTER - III
PSBT301 - Applied Virology & Microbiology
Course
Objectives
Students will be exposed to pandemic diseases, significance of epidemiology in
studying various diseases and societal & economic issues related to such diseases .
Students will also learn details about emerging viral, bacterial, parasitic pathogens.
Students will learn advanced, automated methods for determining antimicrobial
susceptibility, drug resistance and various aspects of biofilms.
Course
Outcomes Students will understand epidemiological principles in prevention , control and
management of pandemic disease. They will acquire understanding of antimicrobial
resistance for management of drug resistance in population. Students will under stand
the different aspects of biofilm and their management. They will also get insights into
latest development of diagnostics & therapeutics for such diseases.
Course
Code Unit Unit Details Credits Lectures
PSBT302
I
Pandemic
diseases ,
pathogenesis,
diagnosis and
treatment
1
1
15 Introduction to Pandemic diseases and
causative agent like H1N1, MERS, SARS,
Swine flu, COVID -19, Nipah virus, Ebola
virus .
Structure of these viruse -coat and envelope
protein, genome composition
Pathogenesis (Mechanism of infection) and
Acute Clinical manifestations (Signs and
symptoms) of H1N1, MERS, SARS, Swine
flu, COVID -19, Nipah virus , Ebola virus
Diagnosis, and Treatment for H1N1,
MERS, SA RS, Swine flu, COVID -19,
Nipah virus, Ebola virus
Economic and Social loss due to t Viruses
II
Epidemiology
of infectious
diseases
15 Concept of Host, Reservoir, Source of
infection, Carrier , Epidemic, Endemic,
Pandemic, Outbreak
History , Definition scope, importance of
epidemiology
Epidemiology, Health & Public Health
Epidemiological principles in prevention &
control of disease
Measures of disease frequency –
Concept of incidence, prevalence,
Incidence rate, cumulative incide nce, case
fatality
Epidemiological studies
Organizations in disease control &
Research – WHO, CDC, UNICEF, NACO,
ICMR, NARI, NIV & NGOs
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Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
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1
1 III
Medical
Microbiology
15 Emerging Pathogens / Infections : Diseases
caused by Bacteria / parasites/ viruses
Name of causative agent, Name of disease
caused, History, Antigenic structure,
virulence factors, source of infection,
Transmission, Pathogenesis, Clinical
manifestatio ns, Laboratory diagnosis,
Treatment, Prophylaxis, vaccines , Current
research and developments
Bacteria as emerging pathogens / Diseases
caused by bacteria :
MOTT, Legionella, Conditions caused by
Helicobacter pylori
Viruses as emerging pathogens / Diseases
caused by viruses : HIV (AIDS),
Chikungunya, Dengue,
Parasites as emerging pathogens / Diseases
caused by parasites : Malaria , Entamoeba
histolytica (Amoebic dysentery)
IV
Biofilms
&
Antimicrobial
Activity
Structure of Biofilm – Extracellular
polymeric substances, Biofilm architecture.
Stages in formation of Biofilm. Microbial
interactions in Biofilms (Quorum sensing)
Need for formation of Biofilms by
microorganisms
Microorganisms commonly associated wit h
biofilms on indwelling medical devices
Response of biofilms to host defense
mechanisms & antimicrobial agents
Recent advances in biofilm management .
Conventional methods of drug
susceptibility testing (Kirby -Bauer disc
diffusion, Stoke’s method, E test )
Advanced methods - Macro & Micro broth
dilution methods, Time kill curves, serum
killing curves, checker -board assays.
Detection of drug resistance in
Staphylococci, Streptococci, Enterococci.
Automated methods of sensitivity testing.
Concept of CLSI standards
15
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Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
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PSBTP -301 Practicals
1. Viral Titering – Plaque Assay, Tissue Culture Infectious Dose (TCID), Chicken Embryo
Infectious Dose (CEID)
2. Immunoassays: For detection of the virus antigens by ELISA / RIA
3. Detection techniques for COVID like RT - PCR and various RAPID tests
4. Diagnosis of dengue (kit method)
5. Diagnosis of Chikungunya (kit method)
6. Antibiotics susceptibility testing by broth Macro dilution method
& Micro broth dilution method
7. Study of microbial biofilm formation on various surfaces &
Biofilm visualization by staining
8. Demonstration of minimum biofilm inhibition concentration of
antibiotics /disinfectant s.
References
1 Microbiology An introduction 10th edition Gerald Tortora, Burdell Funke , Christine
Case, pearson Education Inc. Publication 2010
2 Basic Epidemiology R. Bonita, Bealglehole, T. Kjellstrom, 2nd Edition, 2006, WHO
3 Principles of Epidemiology in Public Health Practice, Third edition, US Department of
Health & Human Services, CDC, 2012
4 Martin Rusnák, Viera Rusnáková, Georges Kamtoh, RELATIONS BETWEEN
EPIDEMIOLOGY AND PUBLIC HEALTH, 2018
https://www.researchgate.net/publication/323964710
5 Evaluation and use of Epidemiological evidence for environmental health risk
assessment guideline document World Health Organization 2000 eur/00/5020369
6 Ananthanarayan and Paniker’s Textbook of Microbiology, by Reba Kanungo,
10thedUniversities Press; Tenth edition, 2017
7 Koneman’s Colour Atlas & Textbook of Diagnostic microbiology, 7th edition, 2017,
Lippincott, Williams & Wilkins.
8 Mackie & McCartney Medical Microbiology, J. G. Collee, J. P.Duguid, A. G. Fraser, B.
P. Marmion, Thirteenth edition, Churchill Livii ngston
9 Bailey and Scotts Diagnostic Microbiology Forbes, Sahem et al 12th ed, Moshby
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Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
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PSBT302 -Environmental Biotechnology
Course Objectives:
This course aims to introduce learners to latest concepts in environmental
biotechnology, various types of pollutions, monitoring, latest mitigation
strategies and management of the same. Health hazards of pollution and
waste , solid waste management, biodiversity concepts and data
management and environmental monitoring.
Course Outcomes:
At the end of the course, students will be able to understand various
concepts of environmental biotechnology, latest development in the area
and use of microbiological, molecular and analytical methods in
environmental biotechnology.
Course
Code Unit Unit Details Credits Lectu
res
PSBT
302
I
Air Air pollution & air Quality Monitoring, Sampling,
Source Apportionment. Air Pollution Management in
Urban Settlement & Rural Areas, Integrated Air
Pollution Management, Green Belt. Biofilters/
Bioscrubber. Catalytic Systems. Green Technology.
Ozone Layer Depletion Atmospheric Brown Cloud
Impact on Flora and Fauna Impact on Crop Yield,
concept of carbon credit, footprint.
1
15
II
Soil Causes of soil salinity; Chemical and metallic
pollution of agricultural soil; Mining and soil
pollution; Soil pollution and air quality;
Bioleaching of metals, bioaugmentation &
biomagnifcation for soil remediation.
Phytostabilization - Contaminant remo val, Soil cover,
Rhizosphere modification, Geotextile capping solid
waste; Industrial solid waste; Domestic solid waste;
Agricultural solid waste; Municipal
solid waste; Major sources of solid wastes; Effects of
solid waste generation on quality of air, wa ter and
public health; solid waste management, Disposal of
organic and medical waste;
Recovery and recycling of metallic waste; Disposal of
plastic waste and hazardous wastes.
1
15
III
Water Biofilms in treatment of waste water; Biofilm
development and biofilm Kinetics; Aerobic Biofilms.
Marine pollution -major pollutants (heavy metal,
pesticide, oil, thermal, radioactive, plastics, litter and
microbial, microplastics); Biological indicators
(Marine microbes, algae and crustaceans) and
accumulators: Biotechnological application of
hazardous waste management of water; Use of
microbial systems, Phytoremediation strategies in
constructed wetlands, Designing constructed wetlands,
Substrate , Hydrauli c loading rate , Hydraulic retention
time, The selection of plant species, Surface area of
1
15
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Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
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wetland, Mechanisms to remove pollutants from
constructed wetlands
IV
Biodiversity
&
Environmen
t
Monitoring Introducing biodiversity informatics, Global patterns
of distribution of biodiversity, biomes, Composition
and distribution of biodiversity in India, Taxonomic
Database Working Group (TDWG) standards,
compatibility and interoperatability, taxonomically
intelligent systems, Global biodiversity information
system -Overview of the UNEP/GEF biodiversity data
management project (BDM), Biosensors in
Environmental Monitoring – Working & its
application for monitoring environment pollutants,
Application of protein b iomarkers ; Biosensors and
biochips. IOT for water quality monitoring – General
working, Application, water Parameters
1
15
PSBTP 302 -PRACTICALS
1. Soil and water quality assessment (temp, pH , salinity, water holding capacity of soil etc .)
2. Study of metal tolerance of microorganisms isolated from soil/water
3. Soil ecosystem analysis/ analysis of microorganisms of soil
4. Analysis of compost
5. Detection of heavy metals conc entration in soil/ water
6. Study and comparison of different air sample rs
7. Growth curve of metal tolerant organism isolated from soil/ water .
REFERENCES
1. Chandrappa, R., & Kulshrestha, U. C. (2015). Sustainable air pollution management:
theory and practice . Springer.
2. Karl B. Schnelle & Charles A. Brown, ( 2002) Air pollution control technology
Handbook. CRC Press
3. Singh, R. L. (Ed.). (2017). Principles and applications of environmental biotechnology
for a sustainable future . Springer Singapore.
4. Enger, E. D., Smith, B. F., & Bockarie, A. T. (2000). Environmental sci ence: A study
of interrelationships (p. 434). Boston, MA: McGraw -Hill.
5. Rittmann, B. E., & McCarty, P. L. (2012). Environmental biotechnology: principles
and applications . Tata McGraw -Hill Education.
6. Wainwright, M. (2012). An introduction to environmental biotechnology . Springer
Science & Business Media.
7. Bolan, N. S., Park, J. H., Robinson, B., Naidu, R., & Huh, K. Y. (2011).
Phytostabilization: a green approach to contaminant containment. In Advances in
agronomy (Vol. 112, pp. 145 -204). Academic Press.
8. Pradhan, A. K., & Pradhan, N. (2015). Microbial biosurfactant for hydrocarbons and
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Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
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heavy metals bioremediation. In Environmental Microbial Biotechnology (pp. 91 -104).
Springer.
9. Rittmann, B. E., & McCarty, P. L. (2012). Environmental biotechnology: princip les
and applications . Tata McGraw -Hill Education.
10. Foin, T. C. (1976). Ecological systems and the environment . Houghton Mifflin.
11. Wise, D. L. (1988). Biotreatment systems: Volume II, Springer.
12. Sheng, Y., Qu, Y., Ding, C., Sun, Q., & Mortimer, R. J. (2013). A combined
application of different engineering and biological techniques to remediate a heavily
polluted river. Ecological engineering , 57, 1-7.
13. Maier, R. M., Pepper, I. L., & Gerba, C. P. (2009). Environmental microbiology (Vol.
397). Academic p ress.
14. Olguni, E.J. et al. (2000) E nvironmental Biotechnology and Cleaner Bioprocess ,
Taylor & Francis.
15. Gareth M. Evams et al. , (2003) Environmental Biotechnology : Therory &
Applications, Wiley.
16. Milton fingerman et al. (1999) Recent Advances in Marine Biotechnology Volume 3,
AbeBooks Inc.
17. Upadhyay, L. S., & Verma, N. (2015). Role of Biosensors in Environmental
Monitoring. In Environmental Microbial Biotechnology (pp. 77 -90). Springer.
18. Geetha, S., & Gouthami, S. (2016). Intern et of things enabled real time water quality
monitoring system. Smart Water , 2(1), 1.
19. Gibas, C., Jambeck, P., & Fenton, J. M. (2001). Developing bioinformatics computer
skills . " O'Reilly Media, Inc.".
20. Attwood, T.K. & Parry -Smith D.J. (2003). Introduction to Bioinformatics . Pearson
Education .
21. Rastogi, S. C., Rastogi, S. C., Mendriratta, N., & Rastogi, P. (2006). Bioinformatics:
Concepts, Skills & Applications . CBS Publishers & Distributors Pvt. Limited.
22. Sensen, C. W. (2005). Handbook of genom e research: genomics, proteomics,
metabolomics, bioinformatics, ethics and legal issues; Vol. 1 und 2 . Wiley -VCH
Verlag GmbH & Co. KGaA.
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Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
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PSBT303 - Biologics & Regulatory Affairs
Course
Objectives:
To introduce learner to the basic concept of Biologics and
Biosimilars, and its therapeutic uses
To expose learner to the methodologies/steps involved in the
production of Biologics/Biosimilars
To educate learner with the nuances of characterization of
Biosimilars with emphasis on Reference Biologic
To familiarize learner with the regulatory aspects of approval of
a Biologic/Biosimilar
Course Outcomes:
At the end of the course, the learner will be:
Familiar with the basic concepts and significance of
Biologics/Biosimilar in addition to having knowledge about its
therapeutic applications
Knowledgeable in the steps involved in the production of
Biologics/Biosimilars
Aware of the protocols/techniques required for characterization
of the Biosimilar relativ e to the Reference Biologic
Acquainted with the regulatory aspe cts of approval of a
Biosimilars.
Cour
se
Code Unit Paper 3:
Biologics & Regulatory Affairs Credits Lectures
PSBT
303 Unit 1
Introducti
on to
Biologics
and
Biosimilar
s
Definition: Drugs, Small molecules, Large
molecules/Biologics Categories of Biologics:
protein -based hormones, enzymes,
monoclonal antibodies, vaccines, blood
products, and gene/ cellular therapies.
Similarities and Differences: Small molecules
versus generics, Biologics ve rsus Biosimilars.
USFDA Approved Small Molecules and
USFDA Approved Generics
USFDA Approved Biologics and USFDA
Approved Biosimilars
Indian Regulatory Scenario in relation to
Small Molecules and Biologics
Therapeutic uses of some of the
Biologics/Bios imilars
Acceptable quality differences between
approved Biosimilar and innovator’s product
1
15
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Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
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Unit 2
Productio
n of
Biologics
and
Biosimilar
s
Reference Biologic and its significance,
Choice of expression system/s and stability of
cell lines
Development of upstream and downstream
processes and scale up to manufacturing
Major factors contributing to the maintenance
of product quality: raw mate rials and
manufacturing conditions, virus filtration,
mycoplasma removal, ultrafiltration
Example: Production of Monoclonal antibody,
downstream processing of Mab
Introduction to the concept of Biobetters vs
Biosimilars
1
1
1 15
Unit 3
Character
ization of
Biologics
and
Biosimilar
s
Appearance, particulates, pH, osmolality,
particle size
Molecular Weight, Protein Sequence and/or
amino acid composition Glycosylation,
Sialylation, Phosphorylation, Acetylation, and
Myristoylation, if any Su lfhydryl gr oups(s)
and di -sulphide bridges. Size and Purity on
HPLC/ MALDI Isoform pattern. Gel
electrophoresis (IEF, SDS PAGE and Native
PAGE), Western blot
Fluorescence spectrum
FTIR spectrum and NMR spectrum
Bioassays , characterization using Mon oclonal
Antibody as an example 15
Unit 4
Quality
assurance
&
regulator
y affairs
of
Biologics
and
Biosimilar
s
Introduction to Regulatory Affairs and
approvals of Biosimilars, Pr oducts approved
under the FD&C . PHS/BCPI Act 2009:
Innovator Biologics Approval, Biosimilar
Pathway, Totality of Evidence, Information
required to demonstrate biosimilarity,
Interchangeability, Product Switching,
Product Naming
Global regulatory framework 15
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Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
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PSBT303 - Practicals:
1) Electrophoresis {PAGE (native, SDS, reducing, non - reducing )} to characterize
the protein with regard to its molecular weight, structure/subunits/SS bonds etc.,
or for detection of impurities in the product
2) Concentration of protein with Folin Lowry
3) Weste rn blot/dot blot for purity of product demonstration/ dummy sandwich
preparation of semi -dry or wet western blot sandwich.
4) HPLC /FTIR/NMR spectrum based theory questions may be asked for
interpretation
5) Visit to a facility manufacturing Biosimilar
1. Biosimilars: Regulatory, Clinical and Biopharmaceutical Development, Editors: Hiten J.
Gutka • Harry Yang • Shefali Kakar, AAPS Advances in the Pharmaceutical, Sciences Series,
Volume 34.
2. https://www.fda.gov/drugs/drug -approvals -and-databases/approved -drug-products -therapeutic -
equivalence -evaluations -orange -book .
3. https://www.fda.gov/drugs/therapeutic -biologics -applications -bla/purple -book -lists-licensed -
biological -products -reference -product -exclusivity -and-biosimilarity .
4. http://nib.gov.in/ NIB-DBT2016.pdf.
5. Biosimilars of Monoclonal Antibodies, A Practical Guide to Manufacturing, Preclinical, and
Clinical Development. Edited by Cheng Liu, Ph.D.,K. John Morro w, Jr., Ph.D., Copyright c
2017 by John Wiley & Sons, Inc. All rights reserved. Published by John Wiley & Sons, Inc.,
Hoboken, New Jersey.
6. Introduction to Biologic and Biosimilar Product Development and Analysis, Karen M. Nagel,
AAPS Introductions in the Pharmaceutical Sciences, Editor -in-Chief: Robin M. Zavod,
Midwestern University, Downers Grove, IL, USA.
7. Regulatory Requirements of ‘Similar Biologics’ for Marketing Authorization in India. Review
Article. Sharmila et al., International Journal of Drug Regualtory Affairs; 2017, 5(1), 20 -24.
8. Introduction to Biosimilars and Regulatory Requirements. Fact Sheet 3. International
Federation of Pharmaceutical Manufacturers & Association (Geneva) & International Alliance
of Patien ts Organization (UK) .
.
PSBT304 - Molecular Enzymology and Enzyme Technology
Course Objectives To get familiarity with the basic concepts of enzymes like enzyme kinetics,
catalytic power of enzymes, active site and transition sate, regulatory and
allosteric enzymes, on protein enzymes.
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Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
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Techniques of enzyme purification and its importance. Need for enzyme
engineering and its benefits and applications.
Role of enzymes as a diagnostic tool and for industrial applications. Use of
enzymes as Biosensors.
Course Outcomes
Enzyme deficiencies and use of enzymes as therapeutics.
At the end of the course the student will be aware of the enzyme kinetics, the
catalytic power of an enzyme, changes in the active site, and the importance of
the transition state. The importance of obtaining enzymes in their pure form and
the ways it can be achieved. The need for and methods for enzyme engineering
to enhance its activity or half life. The significance of enzymes as diagnostic
tools, in therapy, industrial application and as biosensors; and the outcome of
enzyme deficiencies.
Course
code Unit Molecular Enzymology and
Enzyme Technology Credits Lectures
PSBT304 I
Basic concepts - Brief history and introduction;
chemical nature and properties of
enzymes; how enzymes work -
mechanism of action; catalytic
power and specificity of enzymes;
types of catalysis; active site ;
transition state and evidence for
enzyme transition state
complementarity; enzyme kinetics –
factors affecting enzyme activity ;
enzyme inhibition; enzyme
specificity; regulatory enzymes ,
regulat ion of enzyme activity;
allosteric enzymes and their kinetic
properties; units of enzymes; non
protein enzymes; coenzymes and
cofactors; isoenzymes; enzyme
pattern in diseases. 4 15
II
Techniques of
Enzyme purification
and studies/enzyme
engineering Based on molecular size
(Dialysis/ ultrafiltration, density
gradient centrifugation, size
exclusion chromatography); based on
solubility of proteins (Isoelectric
precipitation, salting out); based on
electric charge (Ion exchange
chromatography, Electrophores is-
capillary electrophoresis, 2D
electrophoresis); based on adsorption
properties (Adsorption and Affinity
chromatography). Other techniques:
Immobilized metal ion affinity
chromatography, Hydrophobic
interaction chromatography,
Reversed phase chromatogr aphy and 15
Page 20
Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
Page 19 of 35
Chromatofocusing.
Enzyme engineering – Introduction,
Objectives, Principles, Examples and
Steps involved in enzymes
engineering. Random mutagenesis
and molecular breeding of DNA.
Recent advances in Rational
approaches for Enzyme engineering.
Applications of enzyme engineering.
III
Industrial & medical
application of
enzymes Textile Industry, Detergent Industry ,
Pulp and Paper Industry , Animal
Feed Industry: Enzyme Technology
for Detoxification of Mycotoxins in
Animal Feed , Phytases for Feed
Applications and Leather Industry.
Enzyme Applications for Human and
Animal Nutrition.
Biosensors – Introduction,
instru mentation, Types and
examples. Enzymes based sensors as
diagnostic tools - Biosensors for
Blood Glucose, Biosensors for Urea
in Blood and Urine, Biosensors for
Uric Acid, Biosensors for Arginine,
Biosensors for Asparagine,
Biosensors for Creatinine, Biosens ors
for Cholesterol, Allosteric enzyme -
based biosensors. 15
IV
Enzyme
deficiencies/diagnostic
enzymes/ therapeutics Disorders of amino acid metabolism -
Phenylketonuria, Alkaptonuria,
Homocystinuria. Disorders of
carbohydrate metabolism –
Galactosemia , Hereditary fructose
intolerance, Hereditary lactose
intolerance. Disorder of lipid
metabolism - Gaucher disease, Fabry
disease. Disorders of purine and
pyrimidine metabolism - HGPRT
deficiency, Adenosine deaminase
deficiency, Orotic aciduria.
Enzymes in diagnosis of diseases -
Liver disorders, Cancer, Cardiac
disorders. Role of Other enzymes -
Lysozyme, Butyrylcholinesterase and
Lipases.
Therapeutic uses of enzymes -
enzymes in replacement therapy, 15
Page 21
Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
Page 20 of 35
enzymes in cancer treatment,
enzymes for fibrinolysis, enz ymes
used for various treatments and
enzyme gene therapy.
PSBTP 304 -PRACTICALS
1. Microbial Enzyme production:
a. Partial purification using ammonium sulphate precipitation.
b. Dialysis of the salt -precipitated protein.
c. Assessing the enzyme activity and the protein content.
2. Effect of inhibitors/ chemicals on enzyme activity.
3. Extraction of enzymes from plant sources.
4. Measurement of Enzymatic Activity by Using a Colorimetric Assay.
5. Purification of Acid Phosphatase from Wheat Germ.
6. Enzyme Immunoassays.
a. Methods for Enzyme Immunoassays.
b. Non -competitive Solid -phase Enzyme Immunoassay.
c. Competitive, Solid -phase Enzyme Immunoassay.
7. Determining of Alkaline Phosphatase (ALP) Con centration in Blood Plasma.
8. Measuring Lactase Enzymatic Activity.
9. Screening of new microbial strains for production of enzymes and perform its activity
staining (zymogram).
10. To determine Specific activity of α Amylase from different sources.
REFE RENCES:
1. Lehninger Principles of Biochemistry (4th Ed. Nelson, D., and Cox, M.; W.H. Freeman
and Company, New York, 2005.
2. Satyanarayan and Chakrapani, Biochemistry. New Delhi, Elsevier Health Sciences
APAC, 2013.
3. Berg JM, Tymoczko JL, Stryer L (2 002): Biochemistry, 5th ed., Freeman WH and Co.,
New York.
4. https://shodhganga.inflibnet.ac.in/ bitstream/10603/100595/7/07_chapter%201.pdf
General Introduction to enzymes.
5. https://iopscience.iop.org/ book/978 -0-7503 -1302 -5/chapter/bk978 -0-7503 -1302 -5ch1
Introduction to enzymes and their applications.
6. Biochemistry by Lehninger, 2nd Ed, Kalyani publication 2008.
7. Understanding enzymes (3rd edition). Edited by Trevor Palmer, Ellis Horwood,
Chichester, 1991.
8. Protein purification principles, High Resolution Methods, and Applications, 3rd Edition,
Jan-Christer Janson, John Wiley & Sons, Inc., Hoboken, New Jersey.
9. https://www.biotecharticles.com/ Applications -Article/Methods -of-Purification -of-
Enzymes -583.html
10. https://www.creative -enzymes.com/service/enzyme -purific ation_307.html Enzyme
Purification
11. http://web.sungshin.ac.kr/~spark/class/enzchem/EnzChem_ch02.pdf Chapter 2 -
purification of enzymes
12. https://www.labome.com/method/Protein -Purification.html
13. http://www1.lsbu.ac.uk/water/enztech/index.html Chapter 6 Enz yme preparation and use
Page 22
Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
Page 21 of 35
14. https://docplayer.net/20937505 - Protein -purification -nison -sattaya sai-khon -kaen -
university -thailand -1-introduction -2-extraction -of-protein.html
15. http://www.processdevelopmentforum.com/ppts/posters/ Protein_purification_methods -
_overview,_29155460.pdf
16. https://www.researchgate.net/publication/281102215_ How_to_purify_proteins.
17. Fundamentals of Enzyme Engineering, Young Je Yoo, Yan Feng, Yong -Hwan Kim,
Camila Flor J. Yagonia, : Sp ringer Netherlands 2017.
Page 23
Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
Page 22 of 35
M.Sc. BIOTECHNOLOGY
SEMESTER - IV
PSBT401 - Nanobiotechnology
Course
Objectives
The course aims at providing a general and broad introduction to multi -
disciplinary field of nanotechnology. It will familiarize students with the
synthesis and applications of nanomaterials in the field of medicine. The
course will also give an insight in to complete systems where nanotechnology
can be used to improve our everyday life.
Course
Outcomes Students should be able to understand the basic science behind the properties
of nanomaterials and the principles behind advanced experimental techniques
for studying nanomaterials. Also understand the different aspects and
applications of nanomaterials.
Course
Code UNIT Unit Details Credits Lectures
PSBT401 I
Introduction to
nanotechnology
and nanomaterials Introduction: Nanotechnology,
Nature’s biological pathway,
Examples of nanomaterials and
nanostructures found in nature.
Nanometer -scale materials:
Nanometer -Scale Metals Nano
Metal Oxides, Nanopolymers,
Quantum Dots, Carbon
nanostructures.
Nanorobotiocs devices of nature
ATP synthase, the kinesin, myosin,
dynein, flagella modulated motion. 1 15
II
Synthesis of
Nanomaterials Synthesis of nanometer -scale
materials - Top down and Bottom up
approaches.
Self-Assembly of nanoparticles and
its mechanism.
Bio-directed synthesis and assembly
of nanomaterials
Synthesis and Assembly of
Nanoparticles and Nanostructures
Using Bio -Derived Templates 1 15
III
Nanotechnology
in drug delivery Biological Barriers to Nanocarrier -
Mediated Delivery of Therapeutic
and Imaging Agents, Nano -Sized
Carriers for Drug Delivery, nano
enabled drug delivery system,
nanorobotics in medicine,
Nanomedicine: biopharmaceutics,
implantable materials, implantable
chemicals, surgical aids
1 15
IV Applications of Nanomaterials. 1 15
Page 24
Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
Page 23 of 35
Applications of
nanotechnology
and
Nanotoxicology Nanotoxicology: Unique Properties,
Toxicity of Nanomaterials, Factors
Responsible for the Nanomaterial
Toxicity, Routes of Exposure,
Mechanisms of Nanoparticle
Toxicity, In V itro Testing Methods
for Nanomaterials, Ecotoxicity
Analyses of Nanomaterials
PSBTP 401 -Practicals:
1. Biosynthesis and characterization of eco -friendly silver nanoparticles by using plant/leaf
extracts/green tea
2. Synthesis and characterization of zinc sulfide nanoparticles by A reverse micelle method
3. Synthesis and characterization of Fluorescent Carbon Nanoparticles from Candle Soot and
its separation of using the Thin -Layer Chromatographic Method
4. Synthesis of alginate beads and investigation of citric acid release from a nanoshell coating
of polymer
5. Antimicrobial activity testing of Nanoparticles/nanocomposites
References:
1. Poinern, Gerrard Eddy Jai. A laboratory course in nanoscience and nanotechnology. CRC
Press, 2014.
2. Guozhong, Cao. Nanostructures and nanomaterials: synthesis, properties and applications.
World scientific, 2004.
3. Sulabha K. Kulkarni (auth.) - Nanotechnology_ Principles and Practices -Springer
International Publishing (2015)
4. Crookes -Goodson, W. J., Slocik, J. M., & Naik, R. R. (2008 ). Bio -directed synthesis and
assembly of nanomaterials. Chemical Society Reviews, 37(11), 2403 -2412
5. Chad A. Mirkin, Christof M. Niemeyer - Nanobiotechnology II_ More Concepts and
Applications -Wiley -VCH (2007)
6. Christof M. Niemeyer, Chad A. Mirkin (Editors) - Nanobiotechnology_ Concepts,
Applications and Perspectives -Wiley -VCH (2004)
7. Chad A. Mirkin, Christof M. Niemeyer - Nanobiotechnology II_ More Concepts and
Applications -Wiley -VCH (2007)
8. Oded Shoseyov, Ilan Levy NanoBioTechnology_ BioInspired Devices and Materials of the
Future (2008, Humana Press)
9. Textbook of Nanoscience and Nanotechnology by B.S. Murty, P. Shankar, Baldev Raj, B B
Rath, James Murday
10. Arun Kumar - Nanomedicine in drug delivery -CRC Press _ Taylor & Francis (2013).
11. Yuliang Zhao, Zhiyong Zhan g, and Weiyue Feng - Toxicology of Nanomaterials -Wiley -
VCH (2016)
12. Diwan, Parag, and Ashish Bharadwaj, eds. The Nanoscope: Encyclopedia of Nanoscience
and Nanotechnology. Pentagon Press, 2005. (Vol 1 -6)
Page 25
Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
Page 24 of 35
PSBT 402 -OMICS AND SYSTEMS BIOLOGY
Course
objective:
Bring awareness of the emerging fields of OMICS and Systems Biology, biological
systems as a whole and how parts of a systems interact with each other
To introduce the techniques involved in Genomics, Proteomics, transcriptomics,
Lipidomics and Metabolomics.
To describe the key features of human genome project
To understand the applications of the different OMICS technology to screening,
testing and treatment of human diseases .
Perturbation of biological systems to study various responses in the biological systems
using high throughput techniques.
Introduction to the modellling systems , databases ,computational tools used in
systems biology
Data mining: The unit aims at introducing the concept of knowledge discovery
process, data mining methods and various scientific application of data mining. The
unit also explores application of systems biology in different field of health care.
Course
outcome:
At the end of the course learners will be able to
Understand how the data is generated by OMICS technologies to contribute to
different databases.
Understand , compare and contrast the techniques involved in Genomics, Proteomics,
transcriptomics, Lipidomics and Metabolomics.
Will be able to apply the different technolo gies of OMICS to the screening, testing
and treatment of human diseases .
Understand the structure and dynamics of a systems as a whole .
Apply the different approaches to study systems biology by top down and bottom up
approach.
Introduction to concepts o f knowledge discovery process and data mining methods .
Understand the application of data mining in genomics , proteomics and development
of tools in bioinformatics.
Have the knowledge of applications of systems biology in development of
personali zed medicine, drug development.
Page 26
Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
Page 25 of 35
Course
Code UNIT OMICS AND SYSTEMS BIOLOGY credits lectures
(hours)
PSBT
402
I
OMICS - the
OMICS
technology ,
a broad
outlook
Tools of Omics. Introduction to Epigenomics
Human genome project - goals, conclusions and
application. Structural and functional proteomics -
protein - protein interaction and identification of
interactions by various methods.
Application of Proteomics and Genomics in
human diseases –screening, test ing and treatment
of diseases.
Metagenomics: concept, strategies, and
applications in environmental biotechnology,
agriculture and health
1
1
1
15
II
Transcripto
mics,
Lipidomics
And
Metabolomi
cs Introduction to Transcriptomics, Lipidomics And
Metabolomics, Glycomics, Pharmacogenomics
Techniques used in Lipidomics - Mass
Spectroscopy, TLC, HPLC, GC and Capillary
electrophoresis, MALDI.
Technique used in Metabolomics - Mass
Spectr oscopy, Electrophoresis, chromatography -
GC, LC & NMR.
Technique used in Transcriptomics - next
generation sequencing, northern b lotting, DDRT -
PCR, microarrays, gel free assays like biolayer
interference, SPR.
Applications of transcriptomics metabolomics and
lipidomics in human diseases –screening, testing
and treatment of diseases.(in clinical applications,
personalised medicine, infectious diseases)
15
III
Introduction
to systems
biology Systems biology towards systems level
understanding of biological systemsSystems
structure, systems dynamics,systems design and
control, systems project
Models and Modelling systems in systems biology
What is a model? Key properties of models,Basic
of computational models, networks, data
integration, standards, and model organism
Perturbation of biological systemsand ‘Omics’ as
Quantitative high throughput experimental tools
for systems biology
Standards and formats for systems
biologyComputational Da tabases and software
15
Page 27
Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
Page 26 of 35
PSBTP 402 -PRACTICALS :
1. Gel electrophoresis of lipids ( lipoproteins exrtacted from various sources ) to
separate and identify the lipid fraction
2. Preparation of report based on -Databases and data repositories used in systems Biology
3. Detection assay for gene expression using micro array and qRT –PCR ( demonstration)
4. Identification of protein using analytical technique Mass spectroscopy ( d emonstration)
REFERENCES -
Sr no Title of the book Author Publisher
1. Bioinformatics and functional
genomics (2003 ) Jonathan Pevsner John wiley & sons
Publications
2. Integration of omics
approaches and systems
biology for clinical
applications Antonia Vlahou, Harald
Mischak, Jerome Zoidakis,
Fulvio Magni. Wiley publications
3. Omic technologies :
genomics, transcriptomics,
proteomics and
metabolomics. Richard P. Horgan And Louise
C. Kenny Scientific advisory
committee (sac) , the
obstetricia n and
gynaecologist.
4. Bioinformatics and functional Jonathan Pevsner. Wiley blackwell tools in systems biology.
Biological networks: metabolic networks, gene
regulatory networks, PPI networks, genetic
interaction (GI) networks, and signaling networks
1
IV
Data mining
and
application
of systems
biology Introduction to Knowledge of discovery in
databases (KDD) What is knowledge, need for
KDD,KDD process outline, concept and goals.
Data Mining methods: Statistics – classification,
correlation, association analysis, regression,
and clustering
Machin e learning –Symbolic and statistical
approaches.
Text mining, and Pattern evaluation.
Data mining in scientific applicationsApplication
of systems biology : 1. Systems biology to
systems medicine.
2. Application of systems biology in drug
discovery and development
3. Systems biology and synthetic biology
15
Page 28
Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
Page 27 of 35
genomics, third edition publications
5. Concepts and techniques in
genomics and proteomics - Nachimuthu Saraswathy And
Ponnusamy Ramalingam. Biohealthcare publishing
(oxford) limited
6. Intrduction to proteomics -
tools for the new biology - by Daniel C. Liebler, Humana press totowa, nj
7. Introduction to proteomics
principles and applications By Nawinmishra John wiley & sons, inc.,
publication
8. Multi -omics approaches to
disease Hasin et.,Al; Genome biology (2017)
9. The new science of
metagenomics Committee On Metagenomics:
Challenges And Functional
Applications, National
Research Council, Board On
Life Sciences The national academies
press. www.nap.edu
10. Human molecular genetics
4th edition Tom Strachan And Andrew
Read Garland science
11. Systems biology a textbook,
second edition Edda Klipp, Wolfram
Liebermeister, Christoph
Wierling Axel Kowald Wiley -vch publication
12. Lipidomics -technologies and
applications (2012) Dr. Kim Ekroos Wiley wch publications
13. Topics in current genetics -
metabolomics -a powerful tool
in systems biology Jens Nielsen · Michael C.
Jewett (Eds) Springer publications
14. Foundations of systems
biology. First edition Hiraokikitano(2001) MIT press, Cambridge
15. Systems biology
Karthik Raman and
Nagasuma Chandra, Resonance
February 2010
16. A new approach to decoding
life: systems biology Trey Ideker Article in annual review
of genomics and human
genetics · february 2001
17. systems biology and
synthetic biology (2009) Pengcheng Fu, Sven Panke
Wiley publication
18. Analysis of biological
networks (2008) Bjorn .Junker, Falk Schreiber Wiley
Interscience
19. Knowledge discovery and
data mining in biological
databases Vladimir Brus I C The knowledge
engineering review, vol.
14:3, 1999
20. Computational systems
biology Andrieskreite, Roland Eils Elsevier academic press
21. Introduction To Biological
Networks Alpan Ravaland Animesh Ray CRC press(2013)
22. Advanced systems biology
methods in drug discovery
and translational biomedicine Jun Zou Biomed research
international volume
2013
Page 29
Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
Page 28 of 35
PSBT 403 - Drug Discovery and Clinical Studies
Course
Objectives: The objective of this course is to have a firm foundation in Drug Discovery and
Clinical Studies . To provide students knowledge about Clinical Trial Design and
Indian Regulations , Pharmacovigilance and Clinical Data Science.
Course
Outcomes: By the end of the course the student will:
Able to learn about drug discovery -design pathway using some in -silico tools.
Able to understand the clinical trial design set up as well as they will gain
information on rules -regulation and responsibilities in clinical studies.
Course
Code Unit Drug D iscovery and
Clinical Studies Credit Lectures
PSBT403
I
Clinical Research
Informatics in
Drug Discovery Introduction to the drug discovery &
development
Source of drugs
Structural effects on drug action
Drugs derived from natural products
General principles of pharmacology
Drug development and testing
process
Approaches to new drug discovery
Computer -aided drug design
Identification of novel drug
candidates and drug ta rgets
Construction the signaling network
of a drug using integer linear
programming
Identification for druggable targets
of a disease 1 15
II
Clinical Trial
Design
And
Indian Regulations
Clinical Trial Design
Basic framework of clinical trial
Randomized clinical trials and
different phases
Adaptive randomization methods
Seamless design
Internal pilot design
Design selection factors
Regulations
The national regulatory body
Key documents in clinical research
Regulatory requirements for the
conduct of clinical trials in India
The Roles and Responsibilities of
Stakeholders in the Sharing of
Clinical Trial Data
Participants in clinical trials, 1 15
Page 30
Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
Page 29 of 35
Investigators,
Research institutions and
universities
Journals and Professional societies
III
Pharmacovigilance Scope and purposes of
pharmacovigilance
Adverse Drug Reactions (ADR)
ADR classification
Nature and mechanism of ADR
Concept of safety
Phases and types of DATA
The process of Pharmacovigilance
Signal detection, evaluation and
investigation,
Communication
Methods of evaluating effectiveness
of action
International regulatory
collaboration
WHO, CIOMS, ICH, ISoP, ISPE 1 15
IV
Clinical Data
Science
Data management in clinical
research: An overview
Data Sources and Data Types
Standards in Healthcare Data
Research Data Stewardship for
Healthcare Professionals
Preparing Data for Prediction
Model Development
Prediction Modeling Methodology
Clinical Decision Support System 1 15
PSBTP 403 -PRACTICALS:
1. A finding of a drug -gene interaction or potentially druggable category using The
Drug Gene Interaction Database ( DGIdb )
2. Recognition of binding patterns common to set of protein structures using ProBiS
3. Recognition of common spatial chemical binding patterns to a Set of Protein
Structures using Multi ple Alignment of Protein Bind ing Sites ( MultiBind ) tool and
analysis using RasMol/Jmol
4. Computational protein -ligand docking using AutoDock (DEMO )
Page 31
Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
Page 30 of 35
REFERENCES
Sr
No Title Author Print Details
1 Introduction to Basics
of Pharmacology and
Toxicology, Volume
1: General and
Molecular
Pharmacology:
Principles of Drug
Action, Chapter 3 Gerard Marshall Raj
Ramasamy
Raveendran, Editors ISBN 978 -981-32-9778 -4 ISBN 978 -981-32-
9779 -1 (eBook)
https:oi.org/10 .1007/978 -981-32-9779 -1
2 Basic & Clinical
Pharmacology, 2017,
Fourteenth Edition,
Section I, Chapter 1. Bertram G.
Katzung, Editor ISBN 978 -1-259-64115 -2
MHID 1 -259-64115 -5
ISSN 0891 -2033
3 Software based
approaches for drug
designing and
development: A
systematic review on
commonly used
software and its
applications, Bulletin
of Faculty of
Pharmacy, Cairo
University 55 (2017)
203–210 Prasad G.
Jamkhande,
Mahavir H. Ghante,
Balaji R. Ajgunde http://dx.doi.org/10.1016/j.bfopcu.2017.10.001
4 Bioinformatics and
Drug Discovery,
Third Edition,
(A Computational
Platform and Guide
for Acceleration of
Novel Medicines and
Personalized
Medicine, Chapter
10) Richard S. Larson,
Tudor I. Oprea https://doi.org/10.1007/978 -1-4939 -9089 -4
5 Molecular dockin g
studies, Chapter 5,
Shodhganga
6 Clinical Trial
Designs, Indian
Dermatol Online J .
2019 Mar -Apr; 10(2):
193–201. Brijesh Nair doi: 10.4103/idoj.IDOJ_475_18
PMCID: PMC6434767
PMID: 30984604
7 Experimental designs
for small randomised
clinical trials: an
algorithm for choice, Catherine Cornu et.
al., doi: 10.1186/1750 -1172 -8-48
PMCID: PMC3635911
PMID: 23531234
Page 32
Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
Page 31 of 35
Orphanet J Rare Dis.
2013; 8: 48.
8 Regulatory
requirements for
clinical trials in India:
What academicians
need to know, Indian
J Anaesth
2017;61:192 -9 Nithya J Gogtay,
Renju Ravi, Urmila
M Thatte DOI: 10.4103/ija.IJA_143_17
9 Regulatory
environment for
clinical research:
Recent past and
expected future,
Perspect Clin Res
2017;8:11 -6. Bhave A, Menon S DOI:
10.4103/2229 -3485.198551
10 National Academy
Press, Committee on
Strategies for
Responsible Sharing
of Clinical Trial Data;
(Chapter 3, The Roles
and Responsibilities
of Stakeholders in the
Sharing of Clinical
Trial) Data, Board on
Healt h Sciences
Policy; Institute of
Medicine.
Washington
(DC): National
Academies Press
(US) ; 2015 Apr 20. The National
Academies Press International Standard Book Number -13: 978 -
0-309-31629 -3
11 An Introduction to
Pharmacovigilance,
Second Edition Patrick Waller and
Mira Harrison‐
Woolrych ISBN 9781119289753 (Adobe PDF)
12 Data management in
clinical research: An
overview,
Indian J Pharmacol.
2012 Mar -Apr; 44(2):
168–172. Binny
Krishnankutty,
Shantala Bellary,
and Latha S.
Moodahadu doi: 10.4103/0253 -7613.93842
PMCID: PMC3326906
PMID: 22529469
13 Fundamentals of
Clinical Data Science Pieter Kubben,
Michel Dumontier
Andre Dekker ISBN 978 -3-319-99712 -4 ISBN 978 -3-319-
99713 -1 (eBook)
https://doi.org/10.1007/978 -3-319-99713 -1
Page 33
Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
Page 32 of 35
PSBT 404-Scientific Writing and Food Biotechnology
Course
Objectives : The objective of this course is:
To develop skills for the processing and analysis of scientific data.
To enable students to present their research results in the format of oral
or poster presentations at conferences, to write scientific publications
(theses, articles) and to prepare applications for scientific grants
(research proposals).
To inculcate good scientific writing practices.
Course
Outcomes: On completion of the course students will be able to:
Think critically, organize and analyze scientific data.
Develop advanced scientific writing skills to write research articles,
reviews, thesis, and proposals and to make oral, poster or powerpoint
presentations.
Understand the best practices of scientific writing by adhering to research
ethics and by avoiding plagiarism.
Page 34
Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
Page 33 of 35
course
code Scientific Writing and Food Biotechnology credits lecture
s
PSBT
404 Unit I:
Basic
Scientific
Writing
and
Plagiarism
Introduction to scientific writing.
Basic scientific writing skills: style and language,
spelling, grammar, syntax, jargon and sentence
structure.
Elements of a scientific paper: abstract,
introduction, materials & methods, results,
discussion, references and drafting titles.
Scientific writing process: thinking, planning,
rough draft, revision of content.
Processing data & application of statistics
Displaying data: text, table, graph and defining
terms and abbreviations.
Statistical analysis and tools for experimental
data.
Referencing software: Mendeley, Endnote.
Plagiarism: Definit ion, Common types of
plagiarism, Intentional and Unintentional
plagiarism, Detection of plagiarism by anti-
plagiarism tools (Turnitin, Duplichecker, Viper,
Copyleaks), Penalties for plagiarism, Avoiding
plagiarism. 1 15
Unit II:
Advanced
Scientific
Writing Guidelines for Medical writing.
Scientific writing skills: Writing a research paper
for biomedical journal, Writing science research
papers and articles, Writing a research proposal,
Writing a research report, Writing popular
reports, Writing thesi s and dissertation, Writing
clinical study reports.
Presentation skills: Oral presentation, Poster
Preparation & presentation, Powerpoint
presentations.
Research ethics, Scientific misconduct. 1 15
Unit III:
Food
Biotechnol
ogy-
Nutraceuti
cals Nutraceuticals and functional foods Definition,
characteristic features, and classification,
phytonutraceuticals,
Prebiotics and Probiotics, Sources (with
examples e.g. microbes, plants, algae, animals),
blue biotechnology , food security, food
preservati on, Chemopreservation Food 1 15
Page 35
Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
Page 34 of 35
processing (animal and sea food), food packaging
Unit IV:
Food
biotechnol
ogy in
manageme
nt of
health and
disease Applications of nutraceuticals in human health
and nutrition - health effects of commonly used
nutraceuticals and functional foods (case studies),
Safety and Regulatory guidelines
Nutraceuitcals in management of health and
disease
Development of designer foods for specific
chronic diseases
Nutraceutical adjuvants 1 15
PSBT 404-Practical s
A) Practical: Scientific writing
1. Exploration of various learning platforms in online courses listed below：
a. Online courses in fundamentals of Neuroscience from Harvard University https://online -
learning.harvard.edu/course/fundamentals -neuroscience -part-1-electrical -properties -
neuron?delta=0
b. Molecular Biology from MIT https://ocw.mit.edu/courses/biology/7 -28-molecular -biology -
spring -2005/
c. Introduction to Bioethics from Georgetown
https://bioethicsarchive.georgetown.edu/phlx101 -02/course.html#units/introduction
2. Write a research proposal on any topic of your interest from the MSc syllabus. For
research proposal contents and format refer to NSF guidelines.
https://www.nsf.gov/pubs/policydocs /pappg19_1/nsf19_1.pdf
For reference work use Mendeley Desktop.
https://www.mendeley.com/guides/desktop
3. Complete an online course (Minimum 1 week) on the topic related to the
biotechnology. Write a comprehensive report on the studied course contents.
a. Swayam https://swayam.gov.in/
b. NPTEL https://nptel.ac.in/noc/
c. MOOC https://www.it.iitb.ac.in/frg/wiki/images/7/7b/Demo -PPT.pdf
d. E-learning https://www.bellevuecollege.edu/ele arning/start/intro/
B) Practical: (Food Technology - Nutraceuticals)
1. Estimation of total sugars from food products (dairy, fruit juices, bakery)
2. Determination of acid value of natural fats and oils.
3. Determination of iodine number of fats and oils.
Page 36
Revised Syllabus for M.Sc. (Biotechnology) Semester III and IV
Page 35 of 35
4. Estim ation of vitamin B by HPLC (demonstration)
5. Study of nutraceuticals important plants like Zinziber, Curcuma, Alovera, Asparagus,
Ocimum etc.
6. Estimation of antioxidant property of phytochemical by DPPH.
7. Qualitative test for tannins, phenols, isoflavones, alkaloids using TLC.
8. Estimation of food preservatives/additives (Parabens) from food sample by HPLC
(demonstration).
9. Estimate Cholesterol contents in given sample by Zak’s methods.
10. Estimation of bio -burden by viable counts.
11. Estimation of gluten from food s ample.
12. To study nutritional components (protein, carbohydrate, secondary metabolites, lipids,
vitamin C) of following: Bee honey, Mushrooms, Lentils, Soya, Dairy product, Amla,
Papaya, Spinach
References:
1. Thomas, C George. (2019). Research Methodology and Scientific Writing 2nd edition.
2. Kumar, Ranjeet. (2011). Research methodology: a step-by-step guide for beginners 3rd
edition.
3. Jennifer Peat, Elizabeth Elliott, Louise Baur, and Victoria Keena . (2002). Scientific Writing
(BMJ Books).
4. J.R. Mathews & R.W.Mathews (2008) Successful Scientific Writing, 3rd Ed. Cambridge
University Press.
5. https://www.ema.europa.eu/en/documents/scientific -guideline/ich -e-3-structure -content -
clinical -study -reports -step-5_en.pdf
6. https://www.emwa.org/documents/about_us/EMWAguidelines.pd f
7. https://www.otago.ac.nz/hedc/otago615367.pdf
8. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3510958/
9. http://medind.nic.in/iad/t02/i1/iadt02i1p21.pdf
10. https://intranet.birmingham.ac.u k/as/registry/policy/conduct/plagiarism/interactive -
course.aspx
11. https://www.bowdoin.edu/dean -of-students/judicial -board/ academic -honesty -and-
plagiarism/common -types -of-plagiarism.html
12. https://www.ox.ac.uk/students/academic/guidance/skills/plagiarism?wssl=1
13. https://holyfamily.libguides.com/c.php?g=610218&p=4236572
14. https://plagiarismdetector.net
15. https://www.duplichecker.com