NIPER -GUWAHATI

SYLLABUS
M.S. (Pharm.) Biotechnology

NATIONAL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH

GUWAHATI
SilaKatamur (Halugurisuk), P.O.: Changsari
Dist: Kamrup, Assam, Pin: 781101, Assam, India
E-Mail: [email protected]
Website: www.niperguwahati.ac.in
 NIPER -GUWAHATI

M.S. (Pharm.) Biotechnology

Course No. Course Name Credits

Semester-I
BT-510 Cell Biology 2
BT-520 Microbiology: Basics, Genetics and Genomics 2
BT-530 Biochemistry 2
BT-540 Applied Bioengineering and Fermentation Technology 2
MC-511 Spectral Analysis 2
GE-510 Biostatistics 2
Fundamentals of Intellectual Property (IP) and Technology
GE-520 1
Management
GE-511 Seminar 1
LG-510 General Laboratory Experience 3
TOTAL CREDITS 17
Semester-II
BT-610 Molecular Biology 2
BT-620 Recombinant DNA Technology 2
BT-630 Basic and Applied Immunology 2
Principles and Techniques for Diagnostics and Cell Based
BT-640 2
Screening
BT-650 Nucleic Acids Sequencing and Analysis 2
GE-611 Seminar 1
LS-610 General Lab Experience in the Area of Specialization 2
TOTAL CREDITS 13
Semester-III
Project (22 weeks)
TH-598 Synopsis 5
TH-599 Presentation 3
TOTAL CREDITS 8
Semester-IV
TH-698 Thesis 9
TH-699 Defence of Thesis 3
TOTAL CREDITS 12
GRAND TOTAL CREDITS (I to IV Semesters) 50
 NIPER -GUWAHATI

M.S. (Pharm.) Biotechnology

Semester - I
BT-510 :- Cell Biology (2 Credits)
1. Cell structure and organization: Cells as a unit of life, prokaryotic and eukaryotic
cells, biomembranes, structure and basic functions of various cell organelles i.e.
nucleus, ribosomes, ER, golgi, lysosomes, peroxisomes, exosomes, cytoskeleton.
2. Common methods to study cells and organelles in the laboratory: Histology,
staining, fluorescence, confocal microscopy, TEM and SEM, Fluorescent dyes and
GFP tagged proteins in visualization, FACS, cell fractionation, cell culture, Cell
transformation, Stable cell lines.
3. Organization of tissues: Cell-cell and cell-matrix interactions, cell adhesion
molecules, components of the extracellular matrix, cellular junctions and role.
4. Cell cycle and its regulation: G1, G2, S and M Phase of the cell cycle, Cell cycle
analysis and its applications, programmed cell death apoptosis versus necrosis,
Role of telomeres in the cell cycle.
5. Cell signaling:Receptor concept, receptor signaling and expression, G protein-
coupled receptors, orphan receptors, extracellular signals and cell functions,
hormones, second messengers and hormone actions, growth factor.
6. Transport across membranes: Osmosis, active and passive transport. Protein
transporters, antiporters, symporters, Protein pump, ion channels, Ca++ regulated
events, Vesicular trafficking.
7. Cellular movement and Molecular motors: Types of movement, extravasation,
role of cytoskeletal proteins in movement, The actin-myosin cytoskeleton, The
microtubule cytoskeleton, molecular motors, the movement of cilia and flagella,
myosin and kinesins in the movement of vesicles.
8. Protein Synthesis and Targeting: Ribosome and endoplasmic reticulum,
Secretory pathway, targeting and sorting of proteins, nuclear localization signal,
organelle specific signal sequence, ATP driven translocation, glycosylation,
transport of protein, endocytosis, exocytosis, macropinocytosis.
9. Stem cells: Stem cells and their classification, Tissue-resident stem cells, Stem
cells in clinical practice and regenerative medicine, Cell therapy, Tissue
engineering.
10. Cell-cell communications: Gap junctions and nano tubes, neuronal signaling:
action potential, nerve impulse propagation, synapse, mechanism of
neurotransmitter release; vesicular fusion.
Recommended Books/Literature:
1. Bruce Alberts, Alexander Johnson, Julian Lewis, David Morgan, Martin Raff, Keith
Roberts, and Peter Walter.Molecular Biology of Cell (6th Edition). Garland Science
Publishing.
2. Geoffrey M. Cooper. The Cell: A molecular Approach (8th Edition). Oxford University
Press.
 NIPER -GUWAHATI

BT-520:- Microbiology: Basics, Genetics And Genomics (2 Credits)

1. StructureandFunction ofMicrobes: Overview of microbes and microbial cell
organization. Structure and functions of microbial cell membrane, Outer membrane
lipopolysaccharide, Cell wall, Nucleoid, Ribosomes, Cell inclusions, Flagella, Pili
and Fimbriae.Overview ofArchaeal and Asgardarchaeota diversity, Cell structure
and model organisms.
2. Microbial Growth and Cell Division: Measurement of growth, Growth
physiology, Cell division, Growth yields, Growth kinetics, Steady state growth and
continuous growth, Culturemedia.
3. Microbial Infections: Introduction to pathogenic microbes. Sepsis: Causes,
Symptoms, Treatment, and Prevention. Typhoid: Causes, Symptoms, Treatment,
and Prevention. Diarrhoea: Causes, Symptoms, Treatment, and Prevention.
Tuberculosis: Causes, Symptoms, Treatment, and Prevention. COVID-19: Causes,
Symptoms, Treatment, and Prevention. AIDS: Causes, Symptoms, Treatment, and
Prevention.
4. Microbial Biotechnology:Industry (Food industries, Pharmaceutical Industries),
Introduction to fermentation technology and microbial mass production, Research
(Cloning, recombinant protein production, functional validation of unknown gene),
Therapeutics (antibiotics, vaccines, probiotics).
5. Microbial Genetics: Basic understanding of gene, Allele, Chromosome, genome.
Vertical and horizontal gene transfer, Conjugation, Transformation, transduction,
Fusion. Genetic analysis of bacteria, Transposon, Gene knockout, CRISPR-Cas and
genome editing.
6. Bacterial Genome: Composition, Diversity, Organization and functions of
genome, Linear and circular microbial genome, Dynamics and plasticity of
bacterial genome, Core and shell genomes.
7. Introduction to Virology: Introduction, Classification, Life cycle of Viruses, pro-
virus, Lytic and Lysogenic Phage, Viroid, Prions,Virus genome types, double
stranded DNA (dsDNA), Gapped DNA genomes, Single-stranded (ssDNA)
genomes, Double stranded RNA (dsRNA), Single stranded RNA (ssRNA), (+)
Strand RNA, Single stranded (+) sense RNA with DNA intermediate, Single-
stranded RNA (-) sense, Ambisense RNA genomes.
8. Therapeutics against bacterial and viral pathogens: Antibiotics, Antifungal
agents, Anti-viral drugs, Drug resistance in bacteria and viruses, multidrug efflux
pumps, extended spectrum beta-lactamases (ESBL), antibiotic modification
enzymes. Vaccines, probiotics. Recombinant vaccines, subunit vaccines, DNA
vaccines, Vaccinia-BCG- and HIVvector-based vaccines.
Recommended Books

1. Prescott, Harley and Klein’s Microbiology, Seventh Edition – 2008, M. Willey et. al. McGraw Hills
Publication.
2. Microbiology: An Introduction, VIIIth Edition – 2006, Tortora et.al. Pearson Education.
3. General Microbiology, Fifth Edition – 2007, R. Stanier et.al., Macmillan Press.
 NIPER -GUWAHATI

BT-530 :- Biochemistry (2 Credit)

1. Biomolecules: Introduction, different classes of biomolecules viz carbohydrates,
lipids, Protein nucleic acids, organization of prokaryotic and eukaryotic cells,
structures and functions of biomolecules, pharmaceutical importance.
2. Protein and Nucleic acids: Synthesis, Structure (primary, secondary, tertiary and
quaternary), properties, transport, signal transduction, pharmaceutical importance.
3. Enzymes: Classification, mode of action (activation, specificity), enzyme kinetics,
enzyme inhibitors and regulators, allosteric enzymes, isoenzymes, multienzyme
system, pharmaceutical importance.
4. Coenzymes and cofactors: Coenzymes, classification of vitamins, role and
mechanism of action of some important coenzyme (NAD+/NADP+, FAD, lipoic
acid, tetrahydrofolate, B12- coenzyme), role of cofactors with specific examples.
5. Biochemical energetics: Free energy, , concept of standard free energy, laws of
thermodynamics, anabolism and catabolism, cellular respiration, photosynthesis etc
exergonic and endergonic reactions, energy rich compounds, coupling of reaction,
biological oxidation-reduction.
6. Carbohydrate metabolism: Glycolysis, gluconeogenesis, pentose phosphate
pathways (PPP), TCA cycle, glyoxylic acid cycle, regulation of carbohydrate
metabolism, electron transport chain and oxidative phosphorylation, disorders of
carbohydrate metabolisms.
7. Lipid metabolism: Hydrolysis, absorption and transport of lipids, catabolism of
lipids, beta and omega oxidation of fattyacids, ketone bodies formation,
biosynthesis of fatty acids, disorders of lipid metabolisms.
8. Amino acid metabolism: Hydrolysis, of proteins, pathways of amino acid
degradation, urea cycle and formation of uric acid, assimilation of ammonia,
biosynthesis of amino acids, inborn error of protein metabolism.
9. Nucleic Acid Metabolism: Purine and pyrimidine biosynthesis, salvage pathway,
degradation of nucleotides, role of ribonucleotide reductase, pharmaceutical
importance, disorders of purine and pyrimidine metabolisms.
Recommended Books:
1. David L. Nelson; Michael M. Cox. Lehninger Principles of Biochemistry. Eighth Edition. 2021.
2. LubertStryer; Jeremy Berg; John Tymoczko; Gregory Gatto. Biochemistry. Ninth Edition. 2019.
3. Donald Voet, Judith G. Voet. Biochemistry, 4th Edition.
4. Reginald H. Garrett, Charles M. Grisham. Biochemistry, 6th edition.
5. Denise R. Ferrier, Lippincott Illustrated Reviews: Biochemistry. 7th edition.

BT-540 :- Applied Bioengineering and Fermentation Technology

(2 Credits)
1. Synthetic Biology: Concept and approaches, Application in antibiotic production,
Production of plant metabolites, Future trends.
2. Biomaterials, Bioprinting and Tissue Engineering: Controlled release;
Bioartificial organs; Cell encapsulation; Organ on Chip technology; Organoid
Culture Techniques and Applications.
3. Antibody Engineering: Brief Introduction about antibody and Hybridomas;
Introduction to Antibody Engineering; Next generation antibody technology;
antibody-drug conjugation technologies.
4. Environmental Bioengineering: Bioconversion, Bioremediation, and microbial
fuel cells.
 NIPER -GUWAHATI

5. Fermentation Processes: Overview of fermentation industry; introduction to

Pharmaceutical/Biotechnology Products and Businesses; Modes of bioreactor
operation & ancillary equipment: Basic configuration of bioreactor and ancillaries;
main parameters to be monitored and controlled in fermentation processes; Batch,
Fed-batch and continuous operation; Instrumentation and control of bioprocesses;
Equipping a research scale fermentation lab for production of value-added
products.
6. Media Design and Raw Materials For Fermentation Process: Criteria for
medium design, medium requirements for fermentation processes: types of medium
and its applications; Media Sterilization and Microbial Growth.
7. Transport Phenomenon and Scale-Up: Need of agitation in aerobic fermentation;
Effect of agitation on aeration; different types of agitation methods; Need of
aeration in aerobic fermentation; Effect of aeration; different types of aeration
methods; aeration in high cell density fermentation; Mass transfer and heat transfer
in bioreactors. Scale-up principles and criteria: Different methods of scale up and
design criteria.
8. Downstream Processing: Introduction to downstream processing; Cell disruption:
mechanical, enzymatic and chemical methods. Physical methods of separation:
filtration and centrifugation. Product isolation: Adsorption; liquid-liquid extraction;
aqueous two-phase extraction; membrane separation. Product purification:
principles of chromatographic techniques; instruments and practice. Product
formulation.
Recommended Books:
1. Shuler, M.L. and Kargi, F. “Bioprocess Engineering : Basic Concepts”, 2ndEdition, PHI.
2. P. M. Doran, Bioprocess Engineering Principles, 2nd Edition Elsevier Science & Technology
Books, 2013.
3. Bailey, J.E. and Ollis, D.F. “Biochemical Engineering Fundamentals”, 2nd Edition,McGraw-Hill,
1986.
4. Markus Schmidt. Synthetic Biology: Industrial and Environmental Applications. 1st Edition. Wiley-
Blackwell 2012.
5. Jamie A. Davies. Synthetic Biology: A Very Short Introduction. OUP Oxford. 2018.
6. Florian Ruker. Introduction to Antibody Engineering (Learning Materials in Biosciences). Springer,
2020.
7. LG Zhang, L Leong, JP Fisher. 3D Bioprinting and Nanotechnology in Tissue Engineering and
Regenerative Medicine. Academic Press Inc. 2022.
8. Lewrence K. Wang. Environmental Bioengineering: Volume 11. Humana. 2010.

MC-511:- Spectral Analysis (2 Credits)

1. Ultra Violet (UV) and visible spectroscopy:
a) Energy levels and selection rules: Definitions, molecular orbital approach for
energy absorption, various modes of transitions.
b) Correlation of structural variation with UV absorption: Factors influencing the
position and intensity of absorptions, Inductive and resonance effects, effect of ring
size, influence of stereochemical factors.
c) Predicting UV absorption: Woodward-Fieser, Fieser-Kuhn and Nelson rules;
d) Other factors: Non-conjugative effect, solvent effect, S-Cis band.
2. Infrared (IR)spectroscopy:
a) Characteristic regions of the spectrum: Various modes of vibrations, Energy
levels.
 NIPER -GUWAHATI

b) Correlation of structure with IR spectra: Influence of substituents, ring size,

hydrogen bonding, vibrational coupling and field effect on frequency.
c) Applications: Determination of stereochemistry. Spectral interpretation with
examples
3. Nuclear Magnetic Resonance (NMR)spectroscopy:
a) Fundamentals: Physical basis, magnetic nuclei, resonance, relaxation processes,
signal-sensitivity.
b) Instrumentation: Continuous-Wave (CW) instrument, Pulsed Fourier Transform
(FT) instrument, Functions, Relation with sensitivity, Sampling.
c) 1H NMR, correlation of structure with spectra: Chemical environment and
shielding, chemical shift and origin of its concept, reference compound, local
diamagnetic shielding and magnetic anisotropy, relation with chemical shift,
chemical and magnetic non-equivalence, spin-spin splitting and its origin, Pascal's
triangle, coupling constant, mechanism of coupling, integral, NMR solvents and
their residual peaks, protons on heteroatoms, quadrupole broadening and
decoupling, effect of conformations and stereochemistry on the spectrum, Karplus
relationship, diastereomeric protons, Heteronuclear coupling to F and P, virtual
coupling, long range coupling-epi, peri, bay effects. Shift reagents-mechanism of
action, spin decoupling and double resonance. Explanation of spectra of some
compounds and drugs.
d) 13C NMR correlation of structure with spectra: Chemical environment, shielding
and carbon-13 chemical shift, calculation, proton-coupled C Spetra, Proton-
decoupled C spectra, Nuclear Overhauser Enhancement (NOE), Problem with
integration, Distortionless Enhancement by Polarization Transfer (DEFT),
Heteronuclear coupling for carbon to deuterium, carbon to F, carbon to P.
Explanation of spectra of some compounds and drugs.
4. Mass spectrometry (MS): Molecular ion and metastable peak, fragmentation
patterns, nitrogen and ring rules, McLafferty rearrangement, electron and chemical
ionization modes, applications.
Recommended Books:

1. Spectroscopy by Donald L Pavia, Gary M Lampman, George S Kriz, James A Vyvyan.

2. Organic spectroscopy by William Kemp.
3. Spectroscopic Methods in Organic Chemistry by Dudley H. Williams & Ian Fleming.
4. Spectrometric Identification of Organic Compounds by Robert M. Silverstein, Francis X. Webster
& David J. Kiemie
5. Applications of Absorption Spectroscopy of Organic Compounds by Dyer.
6. Fundamentals of Molecular Spectroscopy by Colin N. Banwell & Elaine M. McCash
7. Spectroscopy by Pavia, Donald L. Lampman, Gary M. Kriz, George S.

GE-510 :- Biostatistics (2 Credits)

1. Statistics: Introduction, its role and uses. Collection; Organization; Graphics and
pictorial representation of data; Measures of central tendencies and dispersion.
Coefficient of variation.
2. Probability: Basic concepts; Common probability distributions and probability
 NIPER -GUWAHATI

distributions related to normal distribution.

3. Sampling: Simple random and other sampling procedures. Distribution of sample
mean and proportion.
4. Estimation and Hypothesis testing: Point and interval estimation including
fiducial limits. Concepts of hypothesis testing and types of errors. Student-t and Chi
square tests. Sample size and power.
5. Experimental design and analysis of variance: Completely randomized,
randomized blocks. Latin square and factorial designs. Post- hoc procedures.
6. Correlation and regression: Graphical presentation of two continuous variables;
Pearson's product moment correlation coefficient, its statistical significance.
Multiple and partial correlations. Linear regression; Regression line, coefficient of
determination, interval estimation and hypothesis testing for population slope.
Introduction to multiple linear regression model. Probit and logit transformations.
7. Non-parametric tests: Sign; Mann-Whitney U; Wilcoxon matched pair; Kruskal
wallis and Friedman two way anova tests. Spearman rank correlation.
8. Statistical techniques in pharmaceutics: Experimental design in clinical trials;
Parallel and crossover designs. Statistical test for bioequivalence. Dose response
studies; Statistical quality control.
Recommended Books:
1. Fundamentals of Biostatistics by Bernard Rosner.
2. Pharmaceutical Statistics: Practical and Clinical Applications by Bolton and Bon.
3. Statistical Misconceptions by Huck GE-520 Fundamentals of Intellectual Property (IP) and
Technology

GE-520 :- Fundamentals of Intellectual Property (IP) and Technology

Management (1 Credit)
10. Intellectual property: Concepts and fundamentals; Concepts regarding intellectual
property (IP), intellectual property protection (IPP) and intellectual property rights
(IPR); Economic importance, mechanisms for protection of intellectual property-
patents, copyrights, trademark; Factors effecting choice of IP protection; Penalities
for violation; Role of IPin pharmaceutical industry; Global ramifications and
financial implications.
11. Trade related aspects of intellectual property rights: Intellectual property and
international trade; Concept behind WTO (World Trade Organisation), WIPO
(World Intellectual Property Organisation) GATT (General Agreement on Tariff
and Trade), TRIPs (Trade Related Intellectual Property Rights),TRIMS(Trade
Related Investment Measures) and GATS(General Agreement on Trade in
Services); Protection of plant and animal genetic resources; Biological materials;
Gene patenting; Biotechnology / drug related IPR issues; Status in India and other
developing countries; Case studies and examples; TRIPS issues on herbal drugs.
12. Nuts and bolts of patenting, copyright and trademark protection criteria for
patentability, types of patents; Indian Patent Act, 1970; WTO and
modifications under TRIPS: Filing of a patent application; Precautions before
patenting-disclosures / non-disclosures, publication-article / thesis; Prior art search-
published patents, internet search patent sites, specialized services-search requests,
costs; Patent application-forms and guidelines, fee structure, time frames,
jurisdiction aspects; Types of patent applications- provisional, non provisional,
PCT and convention patent applications; International patenting-requirement
procedures and costs; Financial assistance for patenting- introduction to schemes by
 NIPER -GUWAHATI

NRDC and TIFAC; Publication of patents-gazette of India, status in Europe and

US; Patent annuity; Patent attomeys technical aspects, criteria for selection,
addresses, fee, rights and responsibilities of a patentee; Practical aspects regarding
maintaining of a PATENT FILE; Patent infrigment- meaning, scope, litigation, case
studies and examples; Patenting by research students, lecturers and scientists
University / organisational rules in India and abroad; Thesis research paper
publication, credit sharing by workers, financial incentives; Useful information
sources for patents related information-internet sites, brouchers, periodicals, CD
roms; Significance of copyright protection for researchers; Indian Copyright Law
and digital technologies-Beme convention, WIPO copyright treaty (WCT), WIPO
performance and Phonogram Treaty (WPPT); Protection for computer data bases,
multi media works; Trade marks legislation and registration system in India-an
introduction, meaning of trademark criteria for eligibility; filling application for
trademark registration; Trade secrets-scope modalities and protection; Case studies-
drug related patents infringements.
13. Technology Development/transfer/commercialisation related aspects:
Technology development-meaning; Drug related technology development;
Toxicological studies, bioequivalence (BU), clinical trials-phase-I, phase-II and
phase-III; Approved bodies and agencies; Scale-up, semi-commercialisation and
commercialisation-practical aspects and problems; Significance of transfer of
technology (TOT), bottlenecks; Managing technology transfer-guidelines for
research students, scientists and related personnal; TOT agencies in India-APCTD,
NRDC, TIFAC, BCIL, TBSE/SIDBI; TOT related documentation-confidentiality
agreements, licensing, MOUs, legal issues; Compulsary licensing excess to
medicine issues; DOHA declaration, POSTWTO product patentregime from 2005;
Challenges for Indian pharmaceutical industry in the context of globalisation of IP;
Drug registration and licensing issues-national and global; Drug master file
submissions, SOPS; Related registration and marketing issues; Case studies
antiretroviral drugs and others.
14. Funding sources for commercialization of technology: Preparation of a project
report, financial appraisal, business models; GOI schemes and incentives; NRDC,
TePP, HGT, TDB schemes. PATSER; Venture capitalists, banks. Incubator
concept-Case studies with respect to IIT,CCMB, IMTECH, NIPER. Documentation
and related aspects.
15. Ethics and values in IP: IP and ethics-positive and negative aspects of IPP;
Societal responsibility; Avoiding unethical practices; Echo-responsibility-
economic, social and environmental benifits of modern biotechnology; Voluntary
adoption of pollution control strategies. 49 60 Courses of Study 2015.
Recommended Books:

6. Law Relating to Intellectual Property by B.L.Wadhera.

7. IPR Handbook for Pharma Students and Researchers by P.Bansal.
8. The Patents Act, 1970 (Bare Act with Short Notes) (New Delhi: Universal Law Publishing
Company Pvt. Ltd. 2012).
9. Patent Agent Examination by Sheetal Chopra and Akash Taneja.
10. Making Innovation Happen- A simple and Effective Guide to Turning Ideas into Reality by
Michael Morgan.
11. Making Breakthrough Innovation Happen by Porus Munshi.
12. Innovation X- Why a Company's Toughest Problems are its Greatest Advantage by Adam
Richardson.
13. Legal Drafting for the Layman by Nabhi Kumar Jain.
 NIPER -GUWAHATI

14. How to Write and Publish a Scientific Paper by Rober A Day.

15. Concise Law Dictionary-with Legal Maxims, Latin Terms and Words and Phrases by Justice
Y.V.Chandrachud.
16. Biomedical Research- From Ideation to Publication by G.Jagadeesh and others.

GE-511 :- Seminar (1 Credit)

1. Introduction, Information retrieval systems.
2. Writing term papers and reports.
3. Organization of scientific material, thesis, dissertation and references.
4. Reading research papers.
5. Skills in oral presentation.
Each student has to present a seminar before end of the semester.
 NIPER -GUWAHATI

M.S. (Pharm.) Biotechnology

Semester - II
BT-610:- Molecular Biology (2 Credits)
1. Genes and Chromosomes : Structure of DNA. Genes.Organization of bacterial
genome. Structure of eukaryotic Chromosomes, Chromatin, Histone proteins.
Repetitive DNA and Telomers.
2. Replication: Replication initiation, elongation and termination in prokaryotes and
eukaryotes, enzymes and accessory proteins, fidelity, replication of single stranded
circular DNA, gene stability.
3. Repair & Recombination: DNA repair-enzymes, photoreactivation, nucleotide
excision repair, mismatch correction; SOS repair, recombination, homologous and
non-homologous, site specific recombination, chi sequences in prokaryotes.
4. Prokaryotic Transcription and regulation Concept of gene expression.
transcription unit, Initiation, elongation and termination. Regulation of gene
expression: Operon concept - lac operon, trp operon and r-Protein synthesis.
5. Eukaryotic transcription and regulation: RNA polymerase structure and
assembly, eukaryotic promoters and enhancers, transcription factors- TATA
binding proteins (TBP) and TBP associated factors (TAF), activators and
repressors. Nuclear transcription factors. Epigenetic regulation by DNA
methylation and CpG Islands. Noncoding RNA. Gene silencing –RNAi.
6. Post-Transcriptional Modifications: Processing of mRNA, tRNA, rRNA, 5'-cap
formation; 3'-end processing and polyadenylation, RNA Splicing, RNA editing,
mRNA stability and localization, catalytic RNA.
7. Translation & Transport: Translation machinery - Ribosomes, composition and
assembly. Universal genetic code - degeneracy of codons, termination codons,
tRNA, Wobble hypothesis. Mechanism of initiation, elongation and termination.
Co-and post translational modifications and localization.
8. Oncogenes and Tumor suppressor genes: Nonsense, missense and point
mutations, Intragenic and Intergenic suppression, Frame shift mutations, Physical,
chemical and biological mutagens. Viral and cellular oncogenes, Tumor suppressor
genes from humans, structure, function and mechanism of action of PRB and p53
tumor suppressor proteins, activation of oncogenes and dominant negative effect,
suppression of tumor suppressor genes, oncogenes as transcriptional activators.
Recommended Books/Literature:
1. Jocelyn E. Krebs; Elliott S. Goldstein; Stephen T. Kilpatrick. Lewin's GENES XII. 12th Edition.
2018.
2. David P. Clark, Nanette J. Pazdernik and Michelle R. McGehee. Molecular Biology. Third Edition.
2019.
3. Malacinski, George M. Freifelder’s Essentials of molecular biology. 4 th Edition.
4. Harvey Lodish et al., Molecular Cell Biology. Ninth Edition. 2021.
5. David L. Nelson; Michael M. Cox. Lehninger Principles of Biochemistry. Eighth Edition. 2021.
 NIPER -GUWAHATI

BT-620 :- Recombinant DNA Technology (2 Credits)

1. Basic of Recombinant DNA Technology: Foundation and Evolution of
Recombinant DNA Technology.
2. Key reagents and their importance in Recombinant DNA technologies: Nucleic
Acids, Plasmids, Enzymes – Restriction Enzymes, Reverse Transcriptase, Ligases,
Polymerases, Alkaline phosphatase, Poly nucleotide kinase etc.
3. Key tools in nucleic acid therapeutics: Antisense technology, siRNA/shRNA,
trans-splicing, ribozymes, aptamers.
4. Applications of DNA Recombinant Technologies:Understanding the biology of
specific genes or pathways; viral vector systems and their uses, Development of
biopharmaceuticals and Biosimilar.
5. Genetically Engineered Animal Models: Transgenic, knock-out and knock-in
mouse generation and their utilization in drug discovery.
6. Applied Research in Plant Biotechnology: High yield and insect resistant crops,
antibody generation in plants, edible vaccines.
7. Gene Therapy: Gene Therapy for hereditary/ genomic diseases.
8. Gene Editing by CRISPR: Basic technology, Applications in Clinic (Disease
control/prevention and therapeutics-hereditary/cancer/rare diseases); Ethical vs
legal issues.

Recommended Books/Literature:
1. Bernard J Glick and Jack J Pasternak, Molecular Biotechnology: Principles and Applications of
Recombinant DNA (4th Edition). ASM Press, Washington DC.
2. Richard M Myers and Amy A Caudy. Recombinant DNA: Genes and Genomes – a Short
Course (3rd Edition). Cold Spring Harbor Laboratory Press.
3. K Rajagopal. Recombinant DNA Technology and Genetic Engineering, Tata McGraw Hill Press.
4. Keya Chaudhury. Recombinant DNA Technology. Published by TERI Press.

BT-630:- Basic and Applied Immunology (2 Credits)

1. Introduction to Immunology: History of Immunology, Innate and Adaptative
Immunity, Types of Immune Responses (self and nonself), Role of Antigens in
Immune Responses, physiology of immune responses.
2. Haematopoiesis and Major Cells of Immune System: Myeloid and Lymphoid
Lineage, Phagocytes, Granulocytes, Lymphocytes (B and T), Natural Killer Cells,
newly discovered immune cells, Primary and secondary Lymphoid Organs.
3. Humoral and Cell Mediated Immunity: Introduction, Cells Involved in Humoral
and Cell Mediated Immunity, Their mechanism of actions.
4. Antibodies: Types, Structure, Source, Functions, Antigen-antibody interactions,
generation of antibodies.
5. Infection, Inflammation and Immunity: Introduction, Inflammation, Chemotaxis,
Cytokines, Inflammatory Diseases, Vascular modifications, Healing and Fibrosis,
Basics of Tumor Immunology, Immune disorders with examples.
6. Immune Tolerance and Autoimmunity: Immune tolerance, immunosuppression,
Auto immunity, Cells Involved, Molecular Mechanism, Hypersensitivity reaction,
Autoimmune disorders and therapies, Gut microbiota and Immunity.
7. Modern Immunotherapy Technologies: Introduction, types of immune therapies
and target diseases, Hybridoma technology, Bi-specific antibodies, Tumor
immunotherapy techniques, CAR-T cell therapy, PDL1 Therapy, Oncolytic viruses.
8. Vaccines: Introduction, Different types of Vaccines and their mode of action,
Challenges, COVID-19 vaccines.
 NIPER -GUWAHATI

Recommended Books/Literature:
1. Kuby Immunology- Kindt, Goldsby, Osborne.
2. Basic Immunology (Functions and Disorders of the Immune System)- AK Abbas, AH
Lichtman, Shiv Pillai.

BT-640:- Principles and Techniques for Diagnostics and Cell Based Screening)
(2 Credits)
1. Analytical Methods for QC of Bio-samples: Protein impurities, contaminants,
electrophoretic analysis, HPLC based analysis, Spectrophotometric Analysis, DNA
and RNA content analysis, immunological assays for impurities, combined
immunological and electrophoretic methods.
2. Immuno-diagnostics: Principles and methods of some clinically used diagnostic
immunoassays, e.g., homogeneous immunoassays, fluorescence,
chemiluminescence and bioluminescence enzyme immunoassays, immunoblot,
immunoaffinity, immunoprecipitation, biotinylation, immunosensors. Multiplexing
ELISA.
3. Molecular diagnostics: DNA probe-based diagnostics, sample preparation,
hybridization, separation, detection, PCR-RFLP in paternity and forensic cases SNP
detection MALDI and DHPLC. PCR and its application for clinical diagnostics.
Real Time PCR and Multiplexing.
4. Molecular Pathology: Basic pathological assays for routine diagnostics using
H&E (infectious diseases, cancer), Disease specific pathological markers using
Immunohistochemistry and In Situ Hubridization. Multiplex Immuno Florescence
Analysis, Introduction of Machine Learning to Clinical Pathology.
5. Introduction to Drug Discovery: Drug Targets. Assay Development and assay
formats: luminescence, fluorescence, etc. Cell free and Cell based assays.
6. Cell Based Screening: Functional cell-based assay – Reporter gene assay.
Automated Cell Based Assays for drug discoveries, Application of Microfluidic
Technologies for single cell assay. Application of Flowcytometry in research and
clinic.
7. High-throughput screening: Chemical Libraries for High-throughput Screening.
Biochemical and cell-based assays for High-throughput screening. Laboratory
automation – assay miniaturization and automation. Target selection to confirmed
Hits – the HTS workflow. Assay technologies for High-throughput screening –
ALPHA Screening, etc.
8. High Content Screening. Introduction to Image-based High-content screening.
Cellomics. HCS applications in drug discovery.
Recommended Books/Literature:
1. David Wild. The Immunoassay Handbook. 4th Edition - 2013. ISBN: 9780080970370.
2. Lela Buckingham. Molecular Diagnostics: Fundamentals, Methods, and Clinical Applications. 3rd
Edition. ISBN-13: 978-0803668294.
3. Joshua A Bittker, Nathan T Ross. High Throughput Screening Methods: Evolution and Refinement.
2017. ISBN- 978-1-78262-471-4.
4. Frank H. Stephenson. Calculations for Molecular Biology and Biotechnology. 3rd Edition. 2016.
ISBN - 978-0-12-802211-5.
5. Taosheng Chen. A Practical Guide to Assay Development and High-Throughput Screening in Drug
Discovery. 2010. ISBN-9780367384708.
 NIPER -GUWAHATI

BT-650:- Nucleic acids sequencing and analysis (2 Credits)

1. Overview of Sanger’s Sequencing: Natural deoxynucleotides (dNTPs) and the
chain-terminating dideoxynucleotides (ddNTPs), primer, polymerase. Applications
and limitations of Sanger’s sequencing.
2. Next-generation sequencing: Overview of massive parallel DNA sequencing in
microfabricated high-density picolitre reactors, semiconductor, and solid layer.
3. Chemistry of next-generation sequencing: Sequencing by Synthesis, Sequencing
by ligation detection, Single-Molecule fluorescent sequencing, Single-Molecule
nanopore-based sequencing.
4. Applications of next-generation sequencing: Whole genome sequencing,
Metagenomic sequencing, RNA sequencing, Real-time single-molecule
sequencing, Exome sequencing, Direct RNA sequencing, Detection of epigenetic
modifications, ChIP-seq.
5. Clinical applications of sequencing: Noninvasive prenatal screening (NIPS),
Somatic cancer genotyping, single-nucleotide variants detection in rare diseases,
Wet-Bench test development and validation, Pathogen identification in culture
negative infections.
6. Next-generation sequencing Platforms: Illumina Solexa genome analyzer
platforms (iSeq, MiSeq, MiniSeq, NextSeq, HiSeq, and NovaSeq), Ion Personal
Genome Machine (PGM), BGI sequencing platforms, Oxford Nanopore sequencing
platforms (MinION, GridION, and PromethION), Roche 454 System, AB SOLiD.
7. DNA sequence analysis: Sequencing read quality analysis, sequence assembly, in
silico annotations, homology search,Basic Local Alignment Search Tool
(BLAST),Conserved Domain Search,sequence deposition in public databases
(NCBI, EBI, DDBJ, GISAID).
8. Basics of computational biology: Database concept; Protein and nucleic acid
databases, structural databases. Computational tools for phylogentic analysis.
Recommended Books/Literature:
1. Next-Generation DNA Sequencing Informatics – Stuart M. Brown, CSHLP publisher, ISBN 978-1-
621821-23-6.
2. DNA Sequencing: The Basics – T.A. Brown, ISBN-13: 978-0199634217.
3. Automated DNA Sequencing and Analysis – Edts. M.A. Adams, C. Fields and J. Craig Venter,
ISBN: 9780127170107, 9780127170107.