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Curricculum & Evalluation Schem

me BT (VII & VIII semesteer) Pagee 1
 BIOTECHNOLOGY
B.Tech. VII Semester
BIOTECHNOLOGY

SEMESTER- VII
Sl. Subject Subject Periods Evaluation Scheme End Total Credit
No. Semester
Codes L T P CT TA Total PS TE PE
1 KHU701/ HSMC -1 / # 3 0 0 30 20 50 100 150 3
KHU702 HSMC-2 #
2 KBT-071-074 Departmental 3 0 0 30 20 50 100 150 3
Elective-IV
3 KBT-075-078 Departmental 3 0 0 30 20 50 100 150 3
Elective-V
4 Open Elective-II 3 0 0 30 20 50 100 150 3
5 KBT751X LAB-1 0 0 2 25 25 50 1
6 KBT752 Mini Project or 0 0 2 50 50 1
Internship
Assessment*
7 KBT753 Project I 0 0 8 150 150 4
8 MOOCs
(Essential for
Hons. Degree)
Total 12 0 12 850 18
*The Mini Project or internship (4 - 6 weeks) conducted during summer
break after VI semester and will be assessed during VIIsemester.

SEMESTER- VIII
Sl. Subject Subject Periods Evaluation Scheme End Semester Total Credit
No.
Codes L T P CT TA Total PS TE PE
1 KHU801/ HSMC- 3 0 0 30 20 50 100 150 3
KHU802 2#/HSMC-1#
2 Open Elective-III 3 0 0 30 20 50 100 150 3

3 Open Elective-IV 3 0 0 30 20 50 100 150 3

4 KBT851 Project II 0 0 18 100 300 400 9

5 MOOCs 9 0 18
(Essential for
Hons. Degree)
Total 850 18

Curriculum & Evaluation Scheme BT (VII & VIII semester) Page 2

 BIOTECHNOLOGY

B.TECH IV YEAR BIOTECHNOLOGY

(DEPARTMENT ELECTIVE SUBJECTS)

DEPARTMENTAL ELECTIVE- IV
KBT071: Genomics and Proteomics
KBT072: Bioseparation and Downstream Processing
KBT073: Environmental Biotechnology
KBT074: Industrial Biotechnology

DEPARTMENTAL ELECTIVE- V
KBT075: Biosafety, Bioethics, IPR & Patents
KBT076: Quality Control and Regulatory affairs
KBT077: Biomaterials
KBT078: Biostatistics & design of experiments

LAB (DEPARTMENTAL ELECTIVE)

KBT751A: Genomics and Proteomic Lab
KBT751B: Bioseparation and Downstream Processing
KBT751C: Environmental Biotechnology Lab
KBT751D: Industrial Biotechnology Lab

Curriculum & Evaluation Scheme BT (VII & VIII semester) Page 3

 BIOTECHNOLOGY
B.TECH IV YEAR VII SEMESTER
BIOTECHNOLOGY

SUBJECT CODE: KBT071 COURSE TITLE: Genomics & Proteomics

EXAM DURATION: 3 HOURS SEMESTER: VII (ODD)

L: T: P :: 3 : 0: 0 CREDIT: 3 PRE-REQUISITE: Molecular Biology & Biochemistry

OBJECTIVE:
 Understand the structural principles governing the protein structures and their classifications.
 Identification of key motifs and domains in protein structures, and their interaction with
ligands orsubstrates; DNA-protein interactions.
 Explain and distinguish various genomic features
 Explain molecular markers, various approaches for genetic and physical mapping of genomes;
andalso analyze recombinant frequency of molecular markers to create genetic maps

COURSE OUTCOME: After completion of this course successfully, the students will be able to:

 Acquire the knowledge for interactions of proteins and other macromolecules along with
methods fortheir identification.
 Comprehend the basics of determination and prediction of three-dimensional structure of
proteins.
 Describe various chemistries/platforms for Next-generation sequencing (NGS); and analyze NGS
datato assemble genomes, annotate the assembly, and predict various kinds of variants.
 Identify genes/pathways/biological processes underlying a phenotype through differential gene
expression analysis (using RNA-seq).

REFERENCE BOOKS:

S.N NAME OF AUTHORS/BOOKS/PUBLISHERS YEAR OF

PUBLICATI
ON
1. Voet D, Voet JG & Pratt CW, Fundamentals of Biochemistry, 2nd ed. Wiley 2006
2. Brown TA, Genomes, 3rd ed. Garland Science 2006
3. Campbell AM & Heyer LJ, Discovering Genomics, Proteomics and 2007
Bioinformatics, 2nd ed. Benjamin Cummings
4. Primrose S & Twyman R, Principles of Gene Manipulation and 2006
Genomics, 7th ed, Blackwell
5. Glick BR & Pasternak JJ, Molecular Biotechnology, 3rd ed, ASM Press 1998

Curriculum & Evaluation Scheme BT (VII & VIII semester) Page 4

 BIOTECHNOLOGY

COURSE DETAIL: GENOMICS & PROTEOMICS

SN CONTANT LECTURE

I. Introduction Structural organization of genome in Prokaryotes and 10

Eukaryotes; Organelle DNA mitochondrial, chloroplast; DNA sequencing-
principles and translation to large scale projects; Recognition of coding and
non-coding sequences and gene annotation; Tools for genome analysis-RFLP,
DNA fingerprinting, RAPD, PCR, Linkage and Pedigree analysis-physical and
genetic mapping
II. Genome sequencing projects Microbes, plants and animals; Accessing and 8
retrieving genome project information from web; Comparative genomics,
Identification and classification using molecular markers-16S rRNA
typing/sequencing, EST’s and SNP’s.
III. Proteomics Protein analysis (includes measurement of concentration, amino- 8
acid composition, N-terminal sequencing); 2-D electrophoresis of proteins;
Microscale solution iso-electric focusing; Peptide fingerprinting; LC/MS-MS
for identification of proteins and modified proteins; MALDITOF; SAGE and
Differential display proteomics, Protein-protein interactions, Yeast two
hybrid system.
IV. Pharmacogenetics High throughput screening in genome for drug discovery- 6
identification of gene targets, Pharmacogenetics and drug development.
V. Functional genomics and proteomics Analysis of microarray data; Protein 8
and peptide microarray-based technology; PCR-directed protein in situ arrays;
Structural proteomics

Curriculum & Evaluation Scheme BT (VII & VIII semester) Page 5

 BIOTECHNOLOGY

SUBJECT CODE: KBT072 COURSE TITLE: Bioseparation & Down Stream

Processing
EXAM DURATION: 3 HOURS SEMESTER: VII (ODD)

L: T: P :: 3 : 0: 0 CREDITS: 3 PREREQUISITE: Knowledge of Molecular

Techniques
OBJECTIVE:
 The major objective of this course is to impart in students the skills to operate bioprocesses
for production of various Bio-products
 This course is formulated to teach various methods of product separation, isolation and
purification To teach the construction of genomic c-DNA libraries, cloning and strain
improvement
COURSE OUTCOME: After completion of the course the students will be able
 to operate, design and optimize the production medium, they will gain the ability to handle
bioreactors to carry out different separation processes involving various types of
bioproducts.
 After completion of this course the students will be skilled in choosing a process of
separation for a particular product, they will know how to design the relevant equipment,
calculate the yield, and degree of purification.

REFERENCE BOOKS:

S.N NAME OF AUTHORS/BOOKS/PUBLISHERS YEAR OF

PUBLICATION
1. Raja Ghosh, “Principles of Bioseparations Engineering”, World Scientific 2006
Publishing
2. Ladisch. M. R, "Bioseparation Engineering: Principles, Practice and Economics", 2001
John Wiley & sons, New York.
3. Asenjo.J.M, "Separation processes in Biotechnology" Marcel Dekker Inc. 1993
4. Bailey & oils, Biochemical Engg. Fundamentals, McGraw-Hill 1990
5. Roger G. Harrison, Paul Todd, Scott R. Rudge, Demetri P. Petrides, 2003
"Bioseparation science and Engineering" Oxford University press.

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 BIOTECHNOLOGY
COURSE DETAILS: BIOSEPARATION & DOWNSTREAM PROCESSING

SN CONTANT LECTURE

I. INTRODUCTION TO BIOSEPARATION PROCESS: Role and 8

importance of bioseparation in biotechnological processes: RIPP scheme,
Problems and requirements of bioproducts purification - Properties of
Biomolecules - Characteristics of fermentation broth - Biological activity,
Analysis of purity-Process economics: Capital and operating cost analysis.
II. REMOVAL OF INSOUBLES: Cell disruption methods for intracellular 8
products: Physical, chemical and mechanical - Removal of insolubles:
Biomass and particulate debris separation techniques - flocculation -
sedimentation - centrifugation and filtration methods.
III. ISOLATION OF PRODUCTS: Adsorption: Principles - Langumir - 8
Freundlich isotherms - Extraction: Basics- Batch and continuous, aqueous
two-phase extraction - supercritical extraction - in situ product removal -
Precipitation: Methods of precipitation with salts - organic solvents and
polymers - Membrane based separations: Micro and ultra filtration - theory -
design and configuration of membrane separation equipments and its
applications.
IV. PURIFICATION OF BIOPRODUCTS: Basic principles of Chromatographic 8
separations: GC-HPLC - gel permeation - ion- exchange -affinity - reverse
phase and hydrophobic interaction chromatography - Electrophoretic
separation techniques: capillary - isoelectric focusing-2D gel electrophoresis -
Hybrid separation technologies: GC-MS and LC-MS.
V. PRODUCT POLISHING: Crystallization: Principles-Nucleation- Crystal 8
growth-Kinetics-Batch crystallizers: Scale-up and design, Drying: Principles-
Water in biological solids- Heat and mass transfer- Drying equipments:
description and operation-Vacuum shelf - rotary dryer-Freeze dryer-Spray
dryer. Biomolecules of Commercial importance Ethanol, citric acid, lysine,
steroids, penicillin, dextran, trehalose, subtilisin, chymosin, vitamin B12,
hepatitis B vaccine, insulin, erythropoietin, monoclonal antibodies.

Curriculum & Evaluation Scheme BT (VII & VIII semester) Page 7

 BIOTECHNOLOGY

SUBJECT CODE: KBT073 COURSE TITLE: Environmental Biotechnology

EXAM DURATION: 3 HOURS SEMESTER: VII (ODD)

L: T: P: 3: 0: 0 CREDITS: 3 PREREQUISITE: Microbiology and Bioprocess

Engineering
OBJECTIVE:
● To teach basics of environment and its challenges in terms of pollution due to various
activities
● To develop understanding of biotechnology and microbiology in treating various kind
of waste Leading to production of various useful products
● To Impart knowledge of core engineering design in environmental waste treatment
using biological processes
● To develop mathematical and analytical skills required to design and operate system for
source-based waste treatment
● To Impart knowledge in the area of regulatory framework and environmental
compliance
COURSE OUTCOME: On successful completion of the course, the student will be able to:
● Distinguish the exact root cause of environmental pollution problems
● Apply the biotechnology core principles in waste treatment system
● Design the novel biological treatment system at institutional as well as industrial scale
● Analyze the outcome of designed system based on mathematical analysis of result
● Understand the regulatory mechanism in the area of environmental compliance laid
down by various agencies

REFERENCE BOOKS:

S.N NAME OF AUTHORS/BOOKS/PUBLISHERS YEAR OF

PUBLICATION
1. WasteWater Engineering Metcalf & Fuddy, 3rd ed. 2013
2. Environmental Processes I-III, J. Winter, 2nd ed., Wiley Publications 2005
3. Environmental Studies-Dwivedi & Mishra, Ed 2007
4. Environmental Biotechnology B.C. Bhattacharya & Ritu Banerjee, Oxford 2007
Press
5. Essentials of Ecology & Environmental Science, S.V.S. Rana, Prentic- 2006
Hall India,
6. Perspectives in Environmental Studies, Anubha Kaushik & C P Kaushik, 2004
7. Agarwal S.K. (1998), Environmental Biotechnology, APH Publishing 1998
Corporation, New Delhi
8. Environmental Sciences – Purohit, Shammi & Agrawal, New Age 2004
International Publishers,Student Edition

Curriculum & Evaluation Scheme BT (VII & VIII semester) Page 8

 BIOTECHNOLOGY

COURSE DETAILS: ENVIRONMENTAL BIOTECHNOLOGY

SN CONTANT LECTURE

I. Environmental pollution: An overview, Land, water, air, and noise, Marine 10

(introduction, sources, effects and measurements). Thermal Pollution,
Nuclear and Radiation Pollution, Type of Radiation, Radioactivity in nature,
Decay chains, Toxic Hydrocarbon, Radioactive waste sunk, Genetic
Consequences.
II. Biotechnology for waste treatment: Biological waste treatments and biofuel 8
production. Microbiology of waste water treatments, Anaerobic digestion
process for Methanogenesis: methanogenic, acetogenic, and fermentative
microbe. Minimal national standards for waste disposal.
III. Engineering design and kinetics behavior analysis of various waste treatments 8
methods, with advanced bioreactor configuration: activated sludge process,
trickling filter, fluidized expanded bed reactor, upflow anaerobic sludge
blanket reactor, contact process, fixed / packed bed reactor, hybrid reactor,
sequential batch reactor
IV. Waste to wealth: bioconversion of agricultural and other highly organic waste 6
materials into gainfully utilizable products – biogas, H2, celluloses and food
and feed stocks. Bioremediation & Biomineralization: land, water,
Contaminated Soil, industries, organic contaminants, heavy metals,
Bioleaching of ores, Recovery of metals, Economical and social aspects of
waste treatment.
V. Environmental Impact Assessment: Relation between development and 8
environment. Sustainable development and carrying capacity. Screening,
scoping. Baseline studies and monitoring. Impact analysis. Public
participation. Methodologies. Environmental Protection Act, 1986, Water
Prevention and Control of Pollution Act, 1974, Water Prevention and Control
of Pollution Cess Act, 1974, Air Prevention and Control of Pollution Act,
1981, Hazardous Wastes (Management and Handling) Rules. International
environmental laws.

Curriculum & Evaluation Scheme BT (VII & VIII semester) Page 9

 BIOTECHNOLOGY

SUBJECT CODE: KBT074 COURSE TITLE: Industrial Biotechnology

EXAM DURATION: 3 HOURS SEMESTER : VII (ODD)

PRE REQUISITES: Knowledge of Microbiology,
L: T: P :: 3:0:0 CREDITS: 3 Biochemistry
OBJECTIVE:
 To provide the knowledge of Industrial Biotechnology.
 To understand the use of living cells such as bacteria, yeast, algae or component of cells like
enzymes, plants and animals to generate industrial products and processes.
 To study techniques for genetic improvement of micro-organisms to improve yield of
bioproducts.
 To provide the knowledge of microbial production of pharmaceuticals.
 To provide knowledge about biofuels.
COURSE OUTCOME: After successful completion of the course the students will be able to:
 Understand the role of industrial biotechnology in improving microbial cells as factories.
 Understand the different types of bioreactors and the production aspects of commodity
chemicals, pharmaceuticals and fine chemicals.
 Apply knowledge of microorganisms in commercial production of flavours, fragrance, and
microbial pigment in textile and industry.
 Apply the process for commercial production of enzyme.
 Understand the concept of biofuels and the process of Microbial Enhanced Oil Recovery
and Microbial Leaching.

REFERENCE BOOKS:

S.N NAME OF AUTHORS/BOOKS/PUBLISHERS YEAR OF

PUBLICATION
1. C. Vogel and C.L. Tadaro, Fermentation and Biochemical Engineering 1996
Handbook: Principles, Process, Design and Equipment, Noyes Publications
2. P.F. Stansbury and A. Whitaker, Principles of Fermentation 1993
Technology: An Introduction to Current Concepts, Pergamon Press
3. Glazer AN, Nikaido H : Microbial Biotechnology: Fundamentals of Applied 2007
Microbiology
4. Wulf Cruger and Anneliese Crueger, Biotechnology: A Textbook of 2003
Industrial Microbiology, Panima Publishing Corporation
5. Malden MA: Industrial Microbiology: An introduction; Blackwell Science 2001
6. H.W. Blanch, S. Drew, D.I.C.Wang and M. Moo-Young, 1985
Comprehensive Biotechnology: The Practice of Biotechnology: Current
Commodity Products, Pergamon Press.

Curriculum & Evaluation Scheme BT (VII & VIII semester) Page 10

 BIOTECHNOLOGY
COURSE DETAILS: INDUSTRIAL BIOTECHNOLOGY

SN CONTANT LECTURE

I. Introduction to Industrial Biotechnology: Overview of fermentation and 8

other industries with their commercial products employing the use of
microorganisms; strain improvement through mutation and recombination in
industrial microorganisms, Integrated Strain improvement program
(Precision Engineering Technology), biosynthetic technology.
II. Microbes in agriculture and food industry: beneficial soil 8
microorganisms, biofertilizers and biopesticides, SCP, microbial production
of wine, beer and vinegar; biopreservatives (Nisin), cheese, biopolymers
(xanthan gum, PHB etc), vitamins; Bioflavours and biopigments; microbial
production of flavours and fragrances; microbial pigments in textile and food
industry.
III. Bioreactors, Production of cell biomass, primary metabolites and 8
enzymes: Different type of Bioreactors and Bioreactor design, Production of
ethanol, acetone, butanol, citric acid, dextran and amino acids, Production of
industrial enzymes such as proteases, amylases, lipases, cellulases, whole
cell biocatalysis, Applications of bioconversion, transformation of steroids
and sterols.
IV. Microbial production of pharmaceuticals and other bioproducts: 8
Antibiotics, enzyme inhibitors and specialty chemicals; production of
Vitamin E, K, B2 and B12, glutamic acid, L-Lysine. Transformation of non-
steroidal compounds, antibiotics, genetic engineering of microorganisms for
production of nonribosomal peptides (NRPS) and polyketides (PKS),
anticancer drugs.
V. Bioenergy-fuel from biomass, production and economics of biofuels, 8
biogas, bio-refineries, Microbial Enhanced Oil Recovery (MEOR).

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 BIOTECHNOLOGY

SUBJECT CODE: KBT-075 COURSE TITLE: Biosafety, Bioethics, IPR & Patents

EXAM DURATION: 3 HOURS SEMESTER : VII (ODD)

L: T: P :: 3:0:0 CREDITS: 3 PRE REQUISITES: Basic biology, GMO’s and bioethics.

OBJECTIVE:
 To learn about the IPR and its legal provisions and to know about the significance of biosafety
in different system.
 To learn about concepts of Patent, Copyright, Trademarks and related IP
 To learn about patent system, biosafety regulatory framework and basics of bioethics
COURSE OUTCOME: After successful completion of the course the students will be able to:
 Get an adequate knowledge on biosafety-regulatory framework for GMO’s in India
 Understand biosafety-regulatory framework for GMOS at international level
 Identify the role bioethics in IPR
 Disseminate knowledge on different tools of IPR o make students aware about current
trends in IPR and Govt. supports in promoting IPR
 Identify the role of Patent and Patent law

REFERENCE BOOKS:

S.N NAME OF AUTHORS/BOOKS/PUBLISHERS YEAR OF

PUBLICATION
1. Beier, F.K., Crespi, R.S. and Straus, T. Biotechnology and Patent protection- 2007
Oxford and IBH Publishing Co. New Delhi.
2. Intellectual property rights and Bio-Technology (Biosafety and Bioethics), 2012
Anupam Singh, Ashwani Singh, NPH, New Delhi
3. Sasson A, Biotechnologies and Development, UNESCO Publications.. 1988
4. Regulatory Framework for GMOs in India,Ministry of Environment and 2006
Forest, Government of India, New Delhi
5. Cartagena Protocol on Biosafety , Ministry of Environment and Forest, 2006
Government of India, New Delhi

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 BIOTECHNOLOGY

COURSE DETAILS: BIOSAFETY, BIOETHICS, IPR & PATENTS

SN CONTANT LECTURE
I. BIOSAFETY-REGULATORY FRAMEWORK FOR GMOS IN INDIA 8
Regulatory framework in India governing GMOs-Recombinant DNA
Advisory Committee (RDAC), Institutional Biosafety Committee (IBC),
Review Committee on Genetic Manipulation, Genetic Engineering Approval
Committee (GEAC), State Biosafety Coordination Committee (SBCC),
District Level Committee (DLC). Recombinant DNA Guidelines (1990),
Revised Guidelines for Research in Transgenic Plants (1998), Seed Policy
(2002), Prevention Food Adulteration Act (1955), The Food Safety and
Standards Bill (2005), Plant Quarantine Order (2003), Regulation for Import of
GM Products Under Foreign Trade Policy (2006-2007), National
Environment Policy (2006). Rules for the manufacture,
use/import/export and storage of hazardous microorganisms/genetically
engineered organisms or cells (Ministry of Environment and Forests
Notification, (1989)
II. BIOSAFETY-REGULATORY FRAMEWORK FOR GMOS AT 8
INTERNATIONAL LEVEL Convention of Biological Diversity (1992) –
Cartagena Protocol on Biosafety – Objectives and salient features of
Cartagena Protocol – Advanced Information Agreement (AIA) procedure –
procedures for GMOs intended for direct use-risk assessment-risk
management-handling, transport, packaging and identification of GMOs-
Biosafety Clearing House-unintentional transboundary movement of GMOs-
Benefits of becoming a party to the Cartagena Protocol- status of
implementation in India.
III. BIOETHICS Distinction among various forms of IPR, ,Prior art for a patent, 8
Patenting live microorganism, Human Genome project and ethical issues,
Animal cloning, human cloning and their ethical issues, Experimenting on
animals. Public education of producing transgenic organism, legal and
socioeconomic impacts of biotechnology, testing drugs on human
volunteers, Hazardous materials used in biotechnology, their handling and
disposal.
IV. INTELLECTUAL PROPERTY RIGHTS Concept of property, rights, duties 8
and Jurisprudential definition, Introduction to patent, copy right, trademarks,
Design, geographical indication. History and evolution of IPR, Economic
importance of IPR, Indian patent act 1970 (amendment 2000), Distinction
among various forms of IPR, invention step, biopiracry and bioprospecting-
Appropriate case studies. Infringement/violation of patent, remedies against
infringement (civil, criminal, administrative)
V. PATENTS AND PATENT LAWS Plant and Animal growers rights patents 8
trade secrets, and plant genetic recourses GATT and TRIPS, Dunkels Draft
Patenting of biological materials, Current Issues of Patents for higher
animal and higher plants, patenting of transgenic organisms, isolated genes
and DNA sequences..

Curriculum & Evaluation Scheme BT (VII & VIII semester) Page 13

 BIOTECHNOLOGY

SUBJECT CODE: KBT076 COURSE TITLE: Quality Control & Regulatory affairs

EXAM DURATION: 3 HOURS SEMESTER: VII (ODD)

L: T: P :: 3 :0: 0 CREDIT: 3 PRE-REQUISITE: IPR & Industrial Management

OBJECTIVE:
 This course is designed with an objective to provide an understanding of the knowledge of
Quality control and Quality management
 To learn the concepts of GMP,GLP, standard test procedure and CPCSEA guidelines in
Biological samples
 To provide the knowledge of Quality review and batch release document, audits of quality
control etc.
 To develop understanding of Good documentation processes, clinical studies guidelines, IP
generation pharmacovigilance and product registration guidelines etc.

COURSE OUTCOME: After completion of this course successfully, the students will be able to:
 Understand basic concept of QC and Quality management
 Explain GLP, GMP, Standard Operating Process and CPCSEA guidelines
 Understand of the quality review and audits of QC practices
 Explain the clinical studies guidelines, Good documentation practices, IPR and product
Registration guidelines etc.

REFERENCE BOOKS:

S.N NAME OF AUTHORS/BOOKS/PUBLISHERS YEAR OF

PUBLICATION
1. Sharp J. Good Pharmaceutical Manufacturing Practice: Rationale and 2005
Compliance. CRC Press
2. Haider SI. Pharmaceutical Master Validation Plan: The Ultimate Guide to 2002
FDA, GMP, andGLP Compliance. St. Lucie Press
3. Swarbrick J. Encyclopedia of Pharmaceutical Technology. Informa 2007
Healthcare
4. Kolman J, Meng P, Scott G. Good Clinical Practice: Standard Operating 1998
Procedures forClinical Researchers. Wiley
5. Signore AA, Jacobs T. Good Design Practices for GMP Pharmaceutical 2005
Facilities. Taylor&Francis Group

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 BIOTECHNOLOGY

COURSE DETAILS: QUALITY CONTROL AND REGULATORY AFFAIRS

SN CONTANT LECTURE

I. Concept and evolution of quality control and quality assurance. Quality control 8
laboratory responsibilities: GLP protocols on non-clinical testing control on
animal house, data generation, integration and storage, standard test procedure,
retention of sample records. CPCSEA guidelines.
II. Quality review and batch release document of finished products, annual product 8
quality review and parametric release, Audits, quality audits of manufacturing
processes and facilities, audits of quality control.
III. Good documentation practices, route cause analysis, corrective action 8
preventive action (CAPA), out of specifications (OOS) and out of trend (OOT),
Clinical studies- ICH GCP (E6) guidelines, post marketing surveillance,
Pharmacovigilance
IV. BABE (bioavailability and bioequivalence) studies, Concepts and management 8
of contract manufacturing guidelines, Statistical Tools for Quality Control and
Precision, Tools of Problem Solving and Continuous Improvement.
V. Introduction, scope and importance of IPR, Concept of trade mark, copyright 8
and patents Product registration guidelines – CDSCO, USFDA, Concept of ISO
9001:2008, 14000, OSHAS guidelines, Quality Strategy for Indian Industry,
Brief concept of IND, NDA, ANDA, SNDA and PAT.

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 BIOTECHNOLOGY

SUBJECT CODE: KBT077 COURSE TITLE: Biomaterials

EXAM DURATION: 3 HOURS SEMESTER: VII (ODD)
L: T: P :: 3 : 0: 0 CREDITS: 3 PREREQUISITE: Knowledge Of Chemistry, Biochemistry,
Molecular Biology

OBJECTIVE:
 This course is designed with an objective to provide an understanding of the basicconcepts
and properties required for a material to be biocompatible.
 To learn about testing & quality assessment of the biomaterials.
 Students will get exposure to latest biomaterials and their application in the area of
biomedical.
COURSE OUTCOME: After successful completion of the course the students will be able to:
 Differentiate whether a material has the compatibility with biological system to be used for
applications.
 To assess the quality of biomaterials,
 To design aspects of new biomaterials or modify existing material for enhancement of
biocompatibility.

REFERENCE BOOKS:

S.N NAME OF AUTHORS/BOOKS/PUBLISHERS YEAR OF

PUBLICATION
1. Biomaterials: An Introduction by Park J.B. and Lakes R.S., Plenum Press, 2007
New York
2. Biomaterials, Medical Devices & Tissue Engineering: An Integrated 1994
Approach by Silver F.H., Chapman and Hall publication.
3. Biomaterials science: an introduction to materials in medicine by Buddy D. 2012
Ratner., Elsevier Academic Press
4. Biomaterials: A Tantalus Experience by Jozef A. Helsen., Yannis Missirlis 2010
Springer
5. Biomaterials by Temenoff Johnna S., Dorling Kindersley India Pvt Ltd. 2007

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 BIOTECHNOLOGY

COURSE DETAILS: Biomaterials

SN CONTANT LECTURE

I. Introduction and overview of biomaterials: Definition of biomaterials – 8

biologically derived materials or materials compatible with biology.
Biomaterials: Classification of bio-materials (based on tissue response), Tissue
engineering, Biosensor.
II. Interactions of materials: Interactions of materials with human body, bio- 8
compatibility of materials, metals (stainless steels, cobalt-chromium alloys,
titanium based alloys, nitinol), Ceramics (carmons, alumina, resorbable ceramics,
surface reactive ceremics), bio polymers(collagens, elastin,
mucopolysachharides, cellulose and derivatives, chitin and other polysaccharides
and composites as biomaterials.
III. Biomaterials for human use :Metallic biomaterials as implants, Bioceramics and 8
ceramic biomaterials, Polymeric biomaterials – classification, natural and
synthetic materials; biomedical applications, Composite biomaterials –
classification, biological responses to composite biomaterials, biomedical
applications..
IV. Quality and Testing of Biomaterials Degradation, Corrosion, Deformation, 8
Fracture, Brittle to ductile transition, Fatigue, Tribology. Recent developments
in biomaterials, legal issues related to development of biomaterials
V. Nanobiomaterials : Definition and classes of nanobiomaterials Polymeric, 8
ceramic and composite nanobiomaterials Scaffolding, tissue engineering
(including stem cells), growth factor delivery with nanobiomaterials

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 BIOTECHNOLOGY

SUBJECT CODE: KBT078 COURSE TITLE: Biostatistics & design of experiments

EXAM DURATION: 3 HOURS SEMESTER: VII (ODD)

L: T: P :: 3 : 0: 0 CREDIT: 3 PRE-REQUISITE: Mathematics

OBJECTIVE:
This course is designed with an objective to provide an understanding of the knowledge of
Biostatistics to students so that they can apply statistics in defining the type and quantity of data
need to be collected as well as organizing and summarizing the data. This course will also be
helpful to analyzing the data,drawing conclusions, and assessing the strengths of the conclusions
and evaluating their uncertainty.
COURSE OUTCOME: After completion of this course successfully, the students will be able to:

 Understand basic concept of handling univariate, bivariate, correlation & regression

 Explain probability, variance and theoretical distribution etc. Understand sampling , statistical
quality control and data analysis
 Explain design of experiment and process control

REFERENCE BOOKS:

S.N NAME OF AUTHORS/BOOKS/PUBLISHERS YEAR OF

PUBLICATION
1. S.C.Gupta & V.K.Kapoor, Fundamentals of Mathematical Statistics, Sultan 2003
Chand and Sons, New Delhi ,
2. W.Ewans & G.Grant, Statistical Methods in Bio informatics – An 2005
Introduction. Springer
3. Chap T. Le and Lynn E. Eberly, Introductory Biostatistics, Wiley 2016

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COURSE DETAILS: BIOSTATISTICS & DESIGN OF EXPERIMENTS

SN CONTANT LECTURE

I. Introduction to bio-statistics, Handling univariate and bivariate data – 8

Measures of central tendency – Measures of dispersion –Skewness & Kurtosis
– Correlation and Regression.
II. Probability concepts, conditional probability, Baye’s theorem, one – 8
dimensional random variables, expectation, variance, moments.
Theoretical distributions: Binomial, Poisson, Normal (Problems only).
III. Sampling, Testing of Hypothesis and Statistical Quality Control: Introduction 8
, Sampling Theory (Small and Large) , Hypothesis, Null hypothesis,
Alternative hypothesis, Testing a Hypothesis, Level of significance,
Confidence limits, Test of significance of difference of means, T-test, F-test
and Chi-square test.
IV. The Analysis of Variance: Concept – Assumptions-One way classification 8
and two-way classifications. Designing Engineering Experiment: Concept of
Randomization, Replication and local control - Completely Randomized
Design -Randomized Block Design –Latin square Design.
V. Basic concepts of statistical quality control. Process control – control charts 8
for variables - X and R, X and s charts control charts for attributes : p chart,
np chart, c chart.

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SUBJECT CODE: KBT751A COURSE TITLE: Genomics & Proteomics Lab

EXAM DURATION: 2 HOURS SEMESTER: VII (ODD)

L: T: P :: 0 : 0: 2 CREDIT: 1 PRE-REQUISITE: Molecular Biology & Biochemistry

OBJECTIVE:
 To isolate genetic materials from bacterial cells
 To determine and characterization of enzyme kinetics
COURSE OUTCOME: After completion of this course successfully, the students will be able to:
 Express and purify recombinant protein in bacterial system
 Characterized purified protein through enzymatic activity and kinetics
 Work with publically available genome sequencing data
 Perform genomic DNA and RNA isolation from bacteria and independently setup qRT-PCR

REFERENCE BOOKS:

S.N NAME OF AUTHORS/BOOKS/PUBLISHERS YEAR OF

PUBLICATION
1. Application of DNA microarrays in Biology 2005
2. Functional Proteomics 2005
3. Proteomic to study genes and genomes 2000

COURSE DETAILS: GENOMICS & PROTEOMICS LAB

SN LIST OF EXPERIMENTS
1. Expression of heterologous protein in bacterial system.
2. Detection of expressed protein.
3. Purification of recombinant protein.
4. Characterization of purified protein using enzymatic activity.
5. Determination of kinetic parameters.
6. Browsing through various publically available genome databases, retrieving and
working with genome data. KEGG genomes, retrieval of genes, proteins and intergenic
regions.
7. Genomic DNA isolation from bacterial strains and estimation of DNA concentration
using Nanodrop, agarose gel electrophoresis.
8. RNA isolation from Synechocystis and quality check (RIN number) using Bioanalyser
chip, cDNA synthesis and qRT-PCR analysis.
9. Demonstration of Agilent’s microarray scanner and DNA microarray protocol.
10. Raw data processing, scatter plots, global normalization of data, fold changes and
finding differentially expressed genes.

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SUBJECT CODE: KBT751B COURSE TITLE: Bioseparation & DownstreamProcessing Lab

EXAM DURATION: 2 HOURS SEMESTER: VII (ODD)

L: T: P :: 0 : 0: 2 CREDIT: 1 PRE-REQUISITE: Basic Knowledge of molecular

biology Techniques
OBJECTIVE:
 To isolate the various bioproducts.
 To develop understanding of bioseparation
 To provide practical knowledge of purification of target bioproducts

COURSE OUTCOME: On successful completion of the course, the student will be able to:
 Understand and explain the bio-separation principles involved in purification of bio-products.
 Evaluate concepts selection of membranes and assess the results of protein purification.
 Design the method for bio-separation of proteins.
 Recover and subsequent purification of target bioproducts.

REFERENCE BOOKS:

S.N NAME OF AUTHORS/BOOKS/PUBLISHERS YEAR OF

PUBLICATION
1. J. Jayaraman, “Laboratory Manual in Biochemistry”, 1st Edition, New Age 1993
International.
2. Keith Wilson and John Walker, Practical Biochemistry—Principles and 2000
Techniques, Cambridge, 5th Ed.

COURSE DETAILS: BIOSEPARATION & DOWNSTREAMPROCESSING LAB

SN LIST OF EXPERIMENTS
1. Characteristics of Bioproducts: Flocculation and conditioning of broth
2. Mechanical separation: Filtration and Centrifugation
3. Determination of volumetric mass transfer coefficient (kLa)
4. Membrane based separation
5. Protein precipitation and its separation: Aqueous two phase extraction, Ultra filtration and
Adsorption
6. Chromatography separation based on size, charge, hydrophobic interaction
7. Gel analysis/ assay for dialyzed product
8. Product crystallization and drying
9. Estimation of Alcohol Content in Wine by Dichromate Oxidation followed by
Redox Titration Chemical Concepts and Techniques
10. Product preservative methods -chemical, physical and natural

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SUBJECT CODE: KBT753C COURSE TITLE: Environmental Biotechnology Lab

EXAM DURATION: 2 HOURS SEMESTER: VII (ODD)

L: T: P :: 0 : 0: 2 CREDIT: 1 PRE-REQUISITE: Basic knowledge of Microbiology and

Bioprocess engineering
OBJECTIVE:
 Hands on experience on water & soil treatments using environmental friendly methods.
 This course is designed to give the students hands-on experience regarding monitoring of
environmental parameters as part of field studies
COURSE OUTCOME: On successful completion of the course, the student will be able to
 Learn about various environment friendly methods for Environmental Biotechnology.
 Identify and appreciate the parameters for assessing environment.

REFERENCE BOOKS:

S.N NAME OF AUTHORS/BOOKS/PUBLISHERS YEAR OF

PUBLICATION
1. Hurst, C.J., Crawford, R.L., Knudsen, G.R., MacInerney, M.J. and 2002
Stetzenbach, L.D., “Manual of Environmental Microbiology”, 2nd Ed., ASM
press

COURSE DETAILS: ENVIRONMENTAL BIOTECHNOLOGY LAB

SN LIST OF EXPERIMENTS
1. Isolation, Identification, characterization of microbes collected from nearby polluted
area/ industries and study of their enzymes.
2. Environmental influence and control of microbial growth.
3. Microbial degradation of textile dyes/pesticides/hydrocarbons and oils
4. To determine BOD value for determining biodegradability of solution
5. To determine COD value for determining organic strength of solution (Closed Reflux
Method)
6. Determination of metals in waste water and their removal.
7. Effluent treatment plant (ETP): Primary, chemical and biological treatment
8. Soil Quality analysis.
9. Water Quality analysis
10. Field Trip : (A) Wastewater Treatment Plant (B) How the community deals with
domestic solid waste (Collection, disposal and treatment)

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SUBJECT CODE: KBT751D COURSE TITLE: Industrial Biotechnology Lab
EXAM DURATION: 2 HOURS SEMESTER : VII (ODD)
L: T: P :: 0:0:2 CREDITS: 1 PRE REQUISITES: Knowledge of Microbiology,
Biochemistry
OBJECTIVE:

To produce various bioproducts from cells and tissues.

To isolate the industrially important microorganisms.

To study techniques for isolation and purification of bioproducts.

To provide the knowledge about determining the various important characteristic of
industrially important enzymes.
COURSE OUTCOME: After successful completion of the course the students will be able to:
 Demonstrate the production of bioproducts like amylase and citric acid and ethanol.
 Isolate the amylolytic microorganism.
 Purify the industrially important enzymes and proteins.
 Can perform the enzymatic assay.

REFERENCE BOOKS:

S.N NAME OF AUTHORS/BOOKS/PUBLISHERS YEAR OF

PUBLICATION
1. Glazer AN, Nikaido H : Microbial Biotechnology: Fundamentals of Applied 1992
Microbiology Eisenthal, R. & Danson N.J. (Eds) Enzyme Assays: “A Practical
Approach”, IRI Press, Oxford, UK
2. Industrial Biotechnology: Products and Processes 2016
3. Laboratory Manual In Industrial Biotechnology By P. Chellapandi 2007
4. Practical Manual on Fermentation Technology by S. Kulandaivelu, S. 2012
Janarthanan

COURSE DETAILS: INDUSTRIAL BIOTECHNOLOGY LAB

SN LIST OF EXPERIMENTS
1. Production and partial purification of Amylase in shake flask culture.
2. Isolation of amylolytic microorganisms.
3. Production of Citric acid using Aspergillus species.
4. Protein precipitation and membrane based separation using dialysis.
5. Purification of Enzyme by ammonium sulphate fractionation.
6. Comparative studies of ethanol production using different substrates.
7. Determination of cellulolytic activity by DNS method.
8. Enzyme assay; activity and specific activity determination of amylase.

Curriculum & Evaluation Scheme BT (VII & VIII semester) Page 23