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SATHYABAMA UNIVERSITY FACULTY OF BIO AND CHEMICAL ENGINEERING PROGRAMME : M. TECH M. SC- BIOTECHNOLOGY CURRICULUM SEMESTER - 1 Sl. No. COURSE CODE COURSE TITLE L T P C PAGE No. 1. SBT5107 Cell Biology and Molecular Genetics 3 1 0 4 33 2. SBT5108 Biochemistry 3 1 0 4 34 3. SBT5109 Microbial Biotechnology 3 1 0 4 35 4. SBT5110 Immunotechnology 3 1 0 4 36 5. SBT5111 Techniques in Biotechnology 3 1 0 4 37 6. SBT5112 Recombinant DNA Technology 3 1 0 4 38 PRACTICAL 7. SBT6533 Biochemistry and Microbiology Lab 0 0 6 3 70 TOTAL CREDITS: 27 SEMESTER - 2 Sl. No. COURSE CODE COURSE TITLE L T P C PAGE No. 1. SBT5113 Plant and Animal Biotechnology 3 1 0 4 39 2. SBT5114 Fermentation and Downstream Processing 3 1 0 4 40 3. Elective I 3 1 0 4 4. Elective II 3 1 0 4 5. Elective III 3 1 0 4 6. S64PT Professional Training 0 0 10 5 PRACTICAL 7. SBT6534 Genetic Engineering and Bioprocess Engineering Lab 0 0 6 3 71 TOTAL CREDITS: 28 SEMESTER - 3 Sl. No. COURSE CODE COURSE TITLE L T P C PAGE No. 1. SBT5202 Nanobiotechnology 3 1 0 4 44 2. Elective IV 3 1 0 4 3. Elective V 3 1 0 4 4. Elective VI 3 1 0 4 5. Project Work - Phase I L - LECTURE HOURS, T – TUTORIAL HOURS, P – PRACTICAL HOURS, C – CREDITS M.E. / M.Tech REGULAR xix REGULATIONS 2015

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SATHYABAMA UNIVERSITY FACULTY OF BIO AND CHEMICAL ENGINEERING

PROGRAMME : M. TECHM. SC- BIOTECHNOLOGY

CURRICULUMSEMESTER - 1

Sl. No. COURSE CODE COURSE TITLE L T P C PAGE No.

1. SBT5107 Cell Biology and Molecular Genetics 3 1 0 4 33

2. SBT5108 Biochemistry 3 1 0 4 34

3. SBT5109 Microbial Biotechnology 3 1 0 4 35

4. SBT5110 Immunotechnology 3 1 0 4 36

5. SBT5111 Techniques in Biotechnology 3 1 0 4 37

6. SBT5112 Recombinant DNA Technology 3 1 0 4 38

PRACTICAL

7. SBT6533 Biochemistry and Microbiology Lab 0 0 6 3 70

TOTAL CREDITS: 27

SEMESTER - 2

Sl. No. COURSE CODE COURSE TITLE L T P C PAGE No.

1. SBT5113 Plant and Animal Biotechnology 3 1 0 4 39

2. SBT5114 Fermentation and Downstream Processing 3 1 0 4 40

3. Elective I 3 1 0 4

4. Elective II 3 1 0 4

5. Elective III 3 1 0 4

6. S64PT Professional Training 0 0 10 5

PRACTICAL

7. SBT6534 Genetic Engineering and Bioprocess Engineering Lab 0 0 6 3 71

TOTAL CREDITS: 28

SEMESTER - 3

Sl. No. COURSE CODE COURSE TITLE L T P C PAGE No.

1. SBT5202 Nanobiotechnology 3 1 0 4 44

2. Elective IV 3 1 0 4

3. Elective V 3 1 0 4

4. Elective VI 3 1 0 4

5. Project Work - Phase I

L - LECTURE HOURS, T – TUTORIAL HOURS, P – PRACTICAL HOURS, C – CREDITS

M.E. / M.Tech REGULAR xix REGULATIONS 2015

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SATHYABAMA UNIVERSITY FACULTY OF BIO AND CHEMICAL ENGINEERING

PRACTICAL

6. SBT6536 Plant and Animal Biotechnology Lab 0 0 6 3 73

TOTAL CREDITS: 19

SEMESTER - IV

Sl. No. COURSE CODE COURSE TITLE L T P C PAGE No.

7. S64PROJ Project Work - Phase I and II 0 0 40 20

TOTAL CREDITS: 20

TOTAL CREDITS FOR THE COURSE: 94

LIST OF ELECTIVES

Sl. No. COURSE CODE COURSE TITLE L T P C PAGE No.

1. SBI5618 Bioinformatics 3 1 0 4 95

2. SBT5611 Enzyme and Enzyme Kinetics 3 1 0 4 117

3. SBT5611 Protein Engineering 3 1 0 4 118

4. SBT5613 Enzyme Engineering 3 1 0 4 119

5. SBT5614 Pharmaceutical Biotechnology 3 1 0 4 120

6. SBT5615 Stem Cell Research 3 1 0 4 121

7. SBT5616 Analytical Techniques in Biotechnology 3 1 0 4 122

8. SBT5617 Cancer Biology 3 1 0 4 123

9. SBT5618 Environmental Biotechnology 3 1 0 4 124

10. SBT5619 Marine Biotechnology 3 1 0 4 125

11. SBT5620 Bioethics, Biosafety and IPR 3 1 0 4 126

12. SBT5621 Biostatistics 3 1 0 4 127

13. SBT5622 GMP and Quality Concepts 3 1 0 4 128

M.E. / M.Tech REGULAR xx REGULATIONS 2015

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SATHYABAMA UNIVERSITY FACULTY OF BIO AND CHEMICAL ENGINEERING

M.E. / M.Tech REGULAR 33 REGULATIONS 2015

SBT5107 CELL BIOLOGY AND MOLECULAR GENETICS L T P Credits Total Marks

3 1 0 4 100

COURSE OBJECTIVE Provides a comprehensive view on the basics of cell biology that includes about the cell structure and cell

organelles. This also details on the various cellular and molecular mechanisms involved in the cells and discusses at the genetic level.

UNIT 1 CELL STRUCTURE 12 Hrs. Comparison between plant and animal cells; Cell wall; Plasma membrane; Electrical properties of membrane, Modification of plasma membrane and intracellular junctions; Organization of plant cell wall. Cytoplasmic organelles - Protoplasm; Mitochondria; Chloroplast; ER; Golgi complex; Lysosome, endosome, Ribosome; Centriole; Nucleus. Cytoskeletal proteins and cell motility , surface antigens and determinants

UNIT 2 OVERVIEW OF CELL CYCLE 12 Hrs. Stages of cell cycle, components and checkpoints in cell cycle regulation.Mitotic and meiotic cell division; Distinction between mitosis in plant and animal .Chromosomes, chromatin and nucleosome: Chromosome structure in bacteria and eukaryotes, centromere, telomere, Hetero- and euchromatin, Nucleosome model and radial-loop scaffold model.

UNIT 3 BIOMEMBRANES 12 Hrs. Plasma membrane: structure-function relationship; Cell signaling: Cell surface, Hormone, receptors and signal transduction and second messengers. Cell differentiation, hormones and growth factors; Apoptosis- The transformed cell; Oncogenes, protooncogenes and etiology of cancer.

UNIT 4 HUMAN CHROMOSOMES 12 Hrs. Structure, number and classification, methods of chromosome preparation, banding patterns. Chromosome abnormalities, Autosomal abnormalities – syndromes, Sex chromosomal abnormalities – syndromes. Patterns of gene inheritance-Single gene pattern inheritance and Multifactorial pattern of inheritance .Autosomal and Sex chromosomal patterns of inheritance.Concept of genome and introduction to genomics.

UNIT 5 POPULATION&REPRODUCTION GENETICS 12 Hrs. Hardy-Weinberg law, Natural selection genetic drift, inbreeding, out breeding, genetic equilibrium.Male infertility, Female Infertility, assisted reproduction, Preimplantation genetics, Prenatal diagnosis, Genetic Counselling -Ethics and Genetics.

Max.60 Hours

TEXT / REFERENCE BOOKS 1. HaveryLodish, Arnold Berk, Lawrence Zipursky, Paul Matsudaira, David Baltimore, James Darnell, Molecular Cell Biology, 5th

Edition, Scientific American Books Inc. 2003. 2. J.D. Watson, N.H. Hopkins, J.W. Roberts, J.A. Steitz and A.M. Weiner, Molecular Biology of the Gene, 4th Edition, The

Benjamin / Cummings Publishers company Inc., California. 1987. 3. Eldon John Gardner, Michael J. Simmons, D. Peter Snustad, Principles of Genetics, 8th Edition, John Wiley & Sons Inc,

2005.

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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SATHYABAMA UNIVERSITY FACULTY OF BIO AND CHEMICAL ENGINEERING

M.E. / M.Tech REGULAR 34 REGULATIONS 2015

SBT 5108 BIOCHEMISTRY L T P Credits Total Marks

3 1 0 4 100

COURSE OBJECTIVE This introduces the students about various biomolecules in the living systems that includes their structure and

functions. Details are provided on the structure of proteins, carbohydrates and lipids and their synthesis mechanisms.

UNIT 1 STRUCTURE & FUNCTIONS OF BIOMOLECULES 12 Hrs. Structure ,Classification & Functions of Carbohydrates, Lipid, Protein ,Fats and Nucleic acids.

UNIT 2 METABOLISM AND REGULATION OF MACROMOLECULES 12 Hrs. Carbohydrates- Glycolysis, aerobic and anaerobic fate of pyruvate, Oxidative phosphorylation, Glucoenogenesis, pentose phosphate pathway, glycogen metabolism and regulations. Nucleic acids- Purine &. Pyramidine synthesis and catabolism synthesis and its regulations . Proteins– Transamination, Deamination, Oxidative deamination, Urea cycle. Aminoacids- Biosynthesis of non-essential aminoacids, catabolism of aminoacids. Lipids- Fatty acid synthesis, -oxidation of fatty acids and its regulations.

UNIT 3 PHOTOSYNTHESIS & ENERGY PRODUCTION 12 Hrs. Plant photosynthesis; Chlorophyll as trapper of solar energy, photosynthetic reaction centres, Hill reaction, PS I & PS II, Photophosphorylation - cyclic & non-cyclic; Dark reaction &CO2 fixation. Oxidative Phosphorylation - Electron-Transfer Reactions in Mitochondria-ATP Synthesis. Photophosphorylation

UNIT 4 TRANSPORTATION IN BIOMEMBRANES, SIGNAL TRANSDUCTION 12 Hrs. Structure of plasma membranes. Transportation of molecules across plasma membrane. Intra cellular and extracellular proteins, Modes of cell signaling, Types of receptors used for cell signaling, pathway of intracellular signal transduction using secondary messengers, Apoptosis

UNIT 5 VITAMINS ,ENZYMES& METABOLIC ERRORS OF BIOMOLECULES 12 Hrs. Fat soluble & Water soluble vitamins and their applications..Enzymes and Isoenzymes and their importance., Estimation of MichaelisMenten parameters, Effect of pH and temperature on enzyme activity, kinetics of inhibition. substrate reactions. Inborn errors of all metabolism.

Max. 60 Hours

TEXT / REFERENCE BOOKS 1. David.L.Nelson and Michael M.Cox., Lehninger Principles of Biochemistry 5th Edition, Macmillan Publishers, Newyork, 2009. 2. Robert K. Murry, Victor W. Rodwell, David Bender, Kathleen M. Botham, P. Antony Weil, Peter. J. Kennelly, Harper’s

Illustrated Biochemistry, 28th Edition, McGraw-Hill Publisher, 2009. 3. Donald Voet and Judith G. Voet, Biochemisty, John Wiley & sons, 3rd Edition, 2005. 4. Lippincott’s Illustrated Reviews: Biochemistry, Pamela C.Champe and Richard A.Harvey, Lippincott Williams & Wilkins

Publication, 4th Edition, 2007. 5. Stryer, L., “Biochemsitry”, 4th Edition, W.H. Freeman & Co., 2000

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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SATHYABAMA UNIVERSITY FACULTY OF BIO AND CHEMICAL ENGINEERING

M.E. / M.Tech REGULAR 35 REGULATIONS 2015

SBT 5109 MICROBIAL BIOTECHNOLOGY L T P Credits Total Marks

3 1 0 4 100

COURSE OBJECTIVE Emphasizes on the various microbial products that are industrially significant. Description is also provided on the

production methods and their applications.

UNIT 1 INTRODUCTION 12 Hrs. Definition, Concepts - history. Scope and Application- Horizons of Microbial technology, Economics of Microbialtechnology; microbial diversity as a rich reservoir of metabolites. Isolation and preservations of microorganisms;public concern about the usage of microbial products.

UNIT 2 MICROBIAL PRODUCTION OF METABOLITES 12 Hrs. Microbial production of Antibiotics - beta-lactam, tetracycline, peptides, aminoglycosides.Enzymes; Proteases, amylases; Organic acids: Citric acid, acetic acid ; Vitamins; VitB12, B2, Amino acids: Glutamicacid, Lysine. EPS.

UNIT 3 MICROBIAL FERMENTATION 12 Hrs. Microorganisms in fermentation - ethanol from feed stocks to fermentable sugars, from sugars to alcohols,Clostridial fermentation, lactic acid fermentation, acetic acid production,Biotransformation of steroid andnon steroid compounds. Vaccines. Recombinant therapeutic proteins: Insulin, erythropoietin.

UNIT 4 AGRICULTURAL BIOTECHNOLOGY 12 Hrs. Biology of nitrogen fixation, preparation of different Types of inoculants (nitrogen fixers phosphate solubilizers, plant growth promoting rhizobacteria, PGPR, composting.Biofertilizers, Bioinsecticides.Genetically modified plants: Bt cotton- process, pros and cons.

UNIT 5 ENVIRONMENTAL BIOTECHNOLOGY 12 Hrs. Degradation capabilities of microorganisms. Microbial degradation of xenobiotics; application of microbes in sewageand waste water treatment; genetic engineering in the control of industrial pollution; microorganism in the leaching of ores, Bioemulsifiers, Biosurfactants, Microbial fuel cells.

Max. 60 Hours TEXT / REFERENCE BOOKS 1. Glazer A.N. and Nikaido H. Microbial Biotechnology. W.H. Freeman and Co., Newyork, 1995. 2. Stanbury P.F. Whittakaer A, Hall, S.J. Principles of Fermentation Technology. Butterworth Heinemann. 1995. 3. Prescott L.M. Harley, J.P. and Klein, D.A. Microbiology. McGraw Hill company, 1999. 4. Glick B.R. and Pasternak, J.J.. Molecular Biotechnology. Washington D.C. American Society of Microbiology Press, 1998.

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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SATHYABAMA UNIVERSITY FACULTY OF BIO AND CHEMICAL ENGINEERING

M.E. / M.Tech REGULAR 36 REGULATIONS 2015

SBT 5110 IMMUNOTECHNOLOGY

(For M.Sc)

L T P Credits Total Marks

3 1 0 4 100

COURSE OBJECTIVES Basic concepts on the human immune system that includes the organs of immune system, types of immunity is

given. Important concepts like applied immunology , immune responses would be discussed.

UNIT 1 FUNDAMENTAL CONCEPTS AND ANATOMY OF THE IMMUNE SYSTEM 12 Hrs. Basic concepts in immunology, Types and components of immunity – Innate And Acquired - Active and Passive, Cells of the immune system: T- cells, B-cells, Surface markers, antigen presenting cells, cell mediated subset of T-cells, helper and suppressor cells, antibody dependent cell mediated cytotoxicity, natural killer cells. Clonal nature of immune response; Organs of the immune system- primary and secondary lymphoid organs; Lymphatic system, Lymphocyte trafficking, Mucosal Immunity.

UNIT 2 HUMORAL IMMUNITY 12 Hrs. ntigens - Nature and biology of antigens, T- dependent, T-independent and superantigens; immunogens, haptens - Hapten-carrier system; antigenic determinants; Basis of self - non-self discrimination; concept of idiotypes and anti-idiotypes, Role and properties of adjuvantsImmunoglobulins - basic structure and functions of classes & subclasses of immunoglobulins, B cell maturation, activation and differentiation; Molecular Biology of Immunoglobulin synthesis, Generation of antibody diversity; Humoral immunity; Complement system - Alternate, Lectin and Classical pathways, Hybridoma technology.

UNIT 3 CELL MEDIATED IMMUNITY 11 Hrs. Major Histocompatibility complex, MHC gene organizations, Class I and Class II MHC molecules: structure and functions; MHC restriction, antigen processing and presentation, HLA typing. Cytokines - properties, receptors, regulation of immune response and therapeutic uses; Immunological Tolerance, Immunomodulation. T-cell maturation, activation and differentiation, T-cell receptors; Cell-mediated immune responses, ADCC, Flow Cytometry.

UNIT 4 CLINICAL IMMUNOLOGY 13 Hrs. Immunity to microbes (protozoa, bacteria, fungi, intracellular parasites, helminthes & viruses); Immune to tumor; AIDS and immunodeficiencies.Hypersensitivity: Types I-IV, features and mechanism of immediate and delayed hypersensitivity reactions; Autoimmunity; Types of autoimmune diseases; Mechanism and role of CD4+ T cells; MHC and TCR in autoimmunity; Treatment of autoimmune diseases;Transplantation immunology - graft vs host reaction, mixed lymphocyte reaction, immunosuppressive therapy.PCD – Apoptosis; Tumor Immunology.

UNIT 5 IMMUNOTECHNIQUES AND VACCINOLOGY 12 Hrs. Antigen - Antibody interactions; Precipitation and agglutination reactions, Immuno diffusion – Mancini and Ouchterlony methods, Immunoelectrophoresis – Rocket, 2D and Counter, Immunofluorescence, ELISA, RIA. Vaccines: Natural and Synthetic; Sub UNIT 5accines, recombinant DNA and protein based vaccines, plant-based vaccines, reverse vaccinology; Peptide vaccines, conjugate vaccines; Genetic, Problem and Prospect associated with development of vaccine for diseases like AIDS, Cancer and Malaria.

Max. 60 Hours

TEXT / REFERENCES 1. Ivan M. Roitt, Brostoff J. and Male D., Essential Immunology, 6th edition, Mosby Harcourt Publishers, 2001. 2. Ivan M. Roitt, Essential Immunology, 4th edition, Blacwell scientific publications, Oxford, London, 1980. 3. Ivan M. Roitt, Jonathan Brostoff and David K. Male Glower, Immunology, 1st edition, Medical publishers, London, 1958. 4. Richard A.Goldsby, Thomas J. Kindt, Barsara A. Osborne, Janis Kuby, Immunology, 5th edition, WH Freeman & Company,

1991 5. Ashim K. Chakravarthy, Immunology, Tata Mcgraw-Hill, 1998.

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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SATHYABAMA UNIVERSITY FACULTY OF BIO AND CHEMICAL ENGINEERING

M.E. / M.Tech REGULAR 37 REGULATIONS 2015

SBT 5111 TECHNIQUES IN BIOTECHNOLOGY L T P Credits Total Marks 3 1 0 4 100

COURSE OBJECTIVE Basic experimental techniques in molecular biology is elaborated. Advanced methodologies like recombinant

screening, molecular mapping and gene tagging.

UNIT 1 TECHNIQUES IN MOLECULAR BIOLOGY 13 Hrs. Agarose gel electrophoresis – principles and mechanism Methods of isolation of DNA and RNA - qualitative and quantitative analysisof DNA and RNA . DNA sequencing techniques; Sanger- Coulson method, Maxam Gilbert method,Automated DNA sequencing. PCR and its applications,PCR steps, Primer designStudying PCR products, Types of PCR , Appilications in in clinical diagnosis, mutagenesis, monitoring of GEMS phylogenetic analysis, genetic markers assisted screening, pathogen detection and biodiversity.

UNIT 2 RECOMBINANT SCREENING 13 Hrs. Introduction of recombinant DNA into prokaryotic and eukaryotic systems. cDNA and genomic libraries. Recombinant screening and selection – markers, nucleic acid hybridizations: colony,plaque, dot blot, southern and northern. Study of gene regulation, DNA transfection, S1 mapping, Primer extension, RNase protection and Reporter assays.Site directed mutagenesis.

UNIT 3 MOLECULAR MAPPING 11 Hrs. Molecular mapping of genome. Genetic and physical maps, Chromosome microdissection and microcloning, Molecular markers in genome analysis(AFLP, RAPD, and AFLP analysis, molecular markers linked to disease resistant genes), Application in forensic, Disease prognosis, Genetic counseling, Pedigree analysis,Taxonomy and biodiversity. DNA microarray technique.

UNIT 4 GENE TAGGING 13 Hrs. Role of gene tagging in gene analysis, T-DNA and transposon tagging, Identification and isolation of genes through T-DNA or transposon. Transgenic and Gene Knockout Technologies, Targeted gene replacement,Chromosome engineering. Gene Therapy: Strategies of gene therapy, gene replacement/augmentation, gene correction, gene editing, gene regulation and silencing.

UNIT 5 BIOSAFETY 10 Hrs Genetic engineering guidelines, cloning and patenting of life forms .BiosafetyIntroduction, GMOs, General Concerns, Hazards of environmental engineering, Guidelines and regulations

Max. 60 Hours TEXT / REFERENCE BOOKS 1. Sambrook and Russell, Molecular Cloning – A laboratory manual Vol 1-3, 3rd, Edition, Cold Spring Harbour Press, New

York, 2001. 2. Bernard R. Glick, Jack J. Pasternak, Jack J. Pasternak. Molecular Biotechnology: Principles & Applications Of Recombinant

DNA,ASM Press, 2003. 3. Rodney Boyer, Modern experimental Biochemistry, 3rd Edition, Pearson Press, 2000. 4. Keith, Wilson and John Walker, Practical Biochemistry - Practice and Techniques, 5th Edition, Cambridge, University Press,

2003.

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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SATHYABAMA UNIVERSITY FACULTY OF BIO AND CHEMICAL ENGINEERING

M.E. / M.Tech REGULAR 38 REGULATIONS 2015

SBT 5112 RECOMBINANT DNA TECHNOLOGY L T P Credits Total Marks

3 1 0 4 100

COURSE OBJECTIVE Introduces the students regarding the tools used in recombinant DNA technology. Concepts on the insertion of

foreign DNA into host cells along with the expression studies is also briefed.

UNIT 1 INTRODUCTION AND TOOLS FOR RECOMBINANT DNATECHNOLOGY 12 Hrs. Introduction and terminology. Milestones in recombinant DNA technology.Restriction enzymes and other DNA modifying enzymes used in rDNA technology.Cloning vectors and expression vectors - plasmids, phages cosmidsand artificial chromosomes. Preparation of DNA: Isolation and purification of DNA and genes, modification of cut ends and ligation of transgene.

UNIT 2 ESSENTIAL TECHNIQUES FOR RECOMBINANT DNA TECHNOLOGY 12 Hrs. Polymerase Chain Reaction (PCR) and its application, Gene libraries: c-DNA and genome libraries, DNA sequencing technologies, hybridization techniques. Isolation of transcripts and full lengthcDNAs, RACE. Differential display. Screening technologies to identify genes that affect a particular trait of interest. Antisense technology. High-throughput genomics -Microarrays.

UNIT 3 INSERTION OF FOREIGN DNA INTO HOST CELLS 12 Hrs. Gene transfer methods- physical, chemicaland biological methods. Selection and screening of recombinants –Methods for clone identification – direct screening (insertional inactivation of marker gene, Visual screening methods), indirect screening: PCR based techniques, immunological techniques, colony hybridization and dot blot hybridization). Karyotyping and gene characterization.

UNIT 4 EXPRESSION OF CLONED DNA AND GMOs 12 Hrs. Gene expression systems - Studying the transcript of a cloned gene.Application of genetic engineering in food (golden rice and other improved nutrictional qualities), agriculture(herbicide resistance, salt/draught tolerance, insect resistance (Bt. protein), designer flowers), aquaculture (giant salmon), medicine (xenotransplantation and gene therapy), industry and environment(vaccines and other biomolecules, plantibodies and bioplastics).

UNIT 5 ETHICAL DILEMMAS SURROUNDING BIOTECHNOLOGY 12 Hrs. Negative impacts of genetic engineering and Present controversies on genetically modified organisms (GMOs). Biosafety Considerations: Biological risks, ethical issues, economic issues, legal issues. Biosafety regulations, norms for rDNA technology experiments. National and internationalregulation of the use of biotechnology.

Max. 60 Hours

TEXT / REFERENCE BOOKS 1. Genes VIII-Benjamin Lewin, Oxford University press, 2004 2. Old RW &Primrose S.B, Principles of Gene Manipulation, Blackwell Scientific pub., USA, 6ThEdition, 2004. 3. DM Glover: Genecloning: The mechanism of DNA manipulation IRC Press, Oxford University, 1984. 4. Brown T.A , Gene Cloning an Introduction, VNR (UK) Co.Ltd. 1988. 5. Ray D.S., Dehardt DT, Dressler D., Single Stranded DNA phages, Cold Spring Harbor Monograph archeiver, Vol 8., 1978, 6. Jose Cibelli, Robert P Lanza, Keith H.S. Campbell, Michael D. West, Principles of cloning, Academic press, 2002. 7. Ernet L Winnacker, From genes to clones, Panima publishing corporation, India, 2003. 8. S.S. Purohit, Biotechnology fundamentals and applications, Agrobios (Ind.) Jothpur 2002. 9. Sambrook A. and Russell D.W., Molecular Cloning. A Laboratory Manual, Cold Spring Harbor Laboratory Press, New York,

USA,3rdEdition, Volume 1-3, 2001.

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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SATHYABAMA UNIVERSITY FACULTY OF BIO AND CHEMICAL ENGINEERING

M.E. / M.Tech REGULAR 70 REGULATIONS 2015

SBT 6533 BIOCHEMISTRY AND MICROBIOLOGY LAB L T P C Total Marks 0 0 6 3 100

BIOCHEMISTRY LABORATORY LIST OF EXPERIMENTS 1. Understanding the role of buffers in biological experiments 2. Preparation of buffer of given pH and molarity. (Including principles of pH meter and its calibration) 3. Verification of Beer-Lambert law using colorimeter. (including understanding wavelength, and

significance of lambda max) 4. Quantitative estimation of protein by Lowry’s method 5. Quantitative estimation of DNA by Diphenylamine method 6. Quantitative estimation of Urea by DAM method 7. Quantitative estimation of Creatinine by Jaffe’s method 8. Isolation of pigments from plant leaves and characterization. 9. Isolation of algal pigments. 10. Effect of pH on amylase activity. 11. Effect of substrate concentration on amylase activity. 12. Effect of temperature on amylase activity.

MICROBIOLOGY LABORATORY LIST OF EXPERIMENTS: 1. Techniques for isolation microorganisms

1.1 Pour plate technique 1.2 Spread plate technique

2. Purification of microorganisms from a mixed culture by streak plate technique 3. Preservation of microorganisms

3.1 Glycerol stock method 3.2 Agar slant method

4. MicroscopyPreparation of bacterial smears 4.1 Simple staining 4.2 Negative staining 4.3 Gram staining 4.4 Microscopic examination of live bacterial population: Hanging drop method

5. Biochemical Activities of Microorganisms: IMViC, catalase, oxidase, presumptive identification 6. The Fungi Cultivation and identification of unknown fungi by lactophenol cotton blue staining 7. Introduction to sampling techniques and tools 8. Microbiology of Food

8.1 Methylene Blue Reductase Test 8.2 Microbiological Analysis of Food products

9. Microbiology of water 9.2 Standard Qualitative analysis of water: Presumptive test, Confirmed test, Completed Test

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SATHYABAMA UNIVERSITY FACULTY OF BIO AND CHEMICAL ENGINEERING

M.E. / M.Tech REGULAR 39 REGULATIONS 2015

SBT 5113 PLANT AND ANIMAL BIOTECHNOLOGY

(For M.Sc) L T P Credits Total Marks

3 1 0 4 100

COURSE OBJECTIVE Familiarizes the students with the concepts in plant tissue culture and transformation techniques. Presents the

students information on the animal cells and culture techniques along with the applications and safety regulations.

UNIT 1 PLANT GENOMES AND PLANT TISSUE CULTURE 12 Hrs. Definition, Structure and organization of plant genome, Chloroplast and Mitochondrial genome, Totipotency, Plasticity and cytodifferentiation, Culture environment, Plant Tissue culture media and its components, Methods of sterilization, Different types of culture, Factors affecting in vitro culture, Organogenesis, Micropropagation with shoot apex and nodal cultures (Clonal Propagation), Somatic embryogenesis and synthetic seeds.

UNIT 2 TISSUE CULTURE TECHNIQUES 12 Hrs. Embryo culture and embryo rescue method, In vitro pollination and fertilization, Production of haploid plant through Androgenesis and Gynogenesis, Isolation and culture of protoplasts, protoplast fusion and somatic hybridization, Selection systems for somatic hybrids / cybrids and their characterization, Somoclonal variations, Production of secondary metabolites by plant cell cultures, Germplasm conservation and cryopreservation.

UNIT 3 PLANT TRANSFORMATION TECHNIQUES 12 Hrs. Genetic Transformation methods for production of transgenic plants (Direct, Indirect), Direct: Particle bombardment and electroporation, Chemical gene transformation, Indirect: Agrobacterium mediated genetic transformation-Ti plasmid, Plant virus-CaMV and Gemini viruses, Production of genetically modified plants for herbicide and pest resistant, Molecular farming for therapeutic protein (Plantibodies, Edible Vaccines), Safety regulation for transgenic plants,Current issues related to transgenic plants.

UNIT 4 INTRODUCTION TO CELL LINES 12 Hrs. Types, Primary and secondary cell culture, Transformation, Immortalization, Maintenance of cell lines, Characterization of cell line: Media preparation and preservation, Measurement of cell growth: Direct observation, Enzyme assays and nuclei acid assays, Histological studies: Slide preparation, Nuclear and cytoplasmic staining.

UNIT 5 APPLICATION AND SAFETY REGULATIONS 12 Hrs. Stem cell culture, Embryogenic stem cells and their application, Cryopreservation of gametes and embryos (Animal and Human), invitro fertilization, and embryo transfer.Micro insemination-PZD, ICSI, SUZI, MESA. Transgenic animal: methods of gene delivery-Application of transgenic animals, Safety regulation for transgenic animals, Current issues related to transgenic animals.

Max. 60 Hours

TEXT / REFERENCE BOOKS 1. Adrian Slater, Scoot N., Fowler, Plant Biotechnology: The Genetic Manipulation of Plants, Oxford University Press,Newyork,

2003. 2. Chawla H.S., Introduction to Plant Biotechnology, 2nd Edition, Oxford and IBH Press, 2003. 3. Bhojwani S.S. and Razdan M.K., Plant Tissue Culture Theory and Practice, 1st Edition, Elsevier Sceince 1996. 4. Satyanarayana, U. Biotechnology, Allied Pvt. Ltd. Kolkata, 2007. 5. P. Ramadass, Animal Biotechnology, MJP Publishers, 2008. 6. Ranga M.M, Animal biotechnology Agrobios, 2007, Third Revised, 2004. 7. Ian Freshney, Culture of Animal Cells: A Manual of Basic Technique Wiley-Liss 3rd Edition 2005 8. R.E. Spier and J.B. Griffith, Animal Cell Biotechnology, Academic Press, 1988.

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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SATHYABAMA UNIVERSITY FACULTY OF BIO AND CHEMICAL ENGINEERING

M.E. / M.Tech REGULAR 40 REGULATIONS 2015

SBT 5114 FERMENTATION AND

DOWNSTREAM PROCESSING (For M.Sc)

L T P Credits Total Marks

3 1 0 4 100

COURSE OBJECTIVES Basic concepts of fermentation process, microbial growth kinetics and process control is explained. Microbial

product separation and purification is also discussed.

UNIT 1 INTRODUCTION TO FERMENTATION PROCESS 12 Hrs. The range of fermentation processes - Strain, culture collection management, Inoculum preparation, Scale upof the inoculum - Sterilization, Batch and Continuous sterilization of medium, Aseptic operation, Fermentation process requirements.

UNIT 2 MICROBIAL GROWTH KINETICS 12 Hrs. Understanding optimum conditions, Effect of substrate concentration and residual limiting substrate concentration on biomass production, secondary metabolites. Continuous culture, Comparison of Continuous Batch and continuous culture. Design of a fermenter -ancillary equipment fermenter / Bioreactor types - continuous stirred tanks, air-lift fermenter, tower fermenters

UNIT 3 INSTRUMENTATION AND CONTROL 12 Hrs. Fermentation control systems - manual and automatic control in fermentation processes. Architecture ofFermentation systems, temperature measurement and control, flow measurement and control, pressure measurementand control, measurement of pH and dissolved oxygen and related sensors, Computer applications in fermentation technology. Introduction to PLC and SCADA.

UNIT 4 DOWNSTREAM PROCESSING 12 Hrs. Separation and recovery of fermentation products - Removal of microbial cells and solid matter, foam separation,precipitation, filtration, centrifugation, coagulation - cell disruption - physical and chemical methods, liquid-liquid extraction - solvent recovery, two phase aqueous extraction, supercritical fluid extraction.

UNIT 5 PURIFICATION PROCESSES 12 Hrs. Membrane processes - ultrafiltration, reverse osmosis, crystallization, drying, whole broth processing,chromatography - Adsorption Chromatography, gel permeation, Affinity Chromatography, High performance liquidChromatography, monitoring of downstream processing - product formulation - process integration.

Max. 60 Hours

TEXT / REFERENCE BOOKS 1. Stanbury P.F., Whitaker A. and Hall S.J., Principles of Fermentation Technology, Elsevier Science Publishers, B.V,

Amsterdam, 1998 2. Belter P.A., Cursler E.L. and Hu W.S., Downstream Processing for Biotechnology John Wiley & Sons Publishers, 1998. 3. Harrison R.G., Todd P., Rudge S.R. and Petrides D.P., Bioseparation Science and Engineering Oxford Press, 2003.

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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SATHYABAMA UNIVERSITY FACULTY OF BIO AND CHEMICAL ENGINEERING

M.E. / M.Tech REGULAR 71 REGULATIONS 2015

SBT 6534 GENETIC ENGINEERING & BIOPROCESS ENGINEERING LAB

L T P C Total Marks 0 0 6 3 100

GENETIC ENGINEERING LAB

LIST OF EXPERIMENTS 1. Isolation of genomic DNA from leaf samples - CTAB Precipitation method 2. Estimation of DNA / RNA by UV spectrophotometry 3. Restriction digestion of DNA 4. Construction of restriction map - plasmids 5. DNA ligation 6. Polymerase Chain Reaction - Amplification of DNA of interest/ RAPD 7. Purification of PCR products- gel elution 8. Southern blotting / Western blotting / northern blotting 9. Cloning of PCR products (competitive cell preparation, CaCl2 transformation, blue - white screening of

transformants.

BIOPROCESS ENGINEERING LAB 1. Growth

1.1 Bacterial growth curve and determination of generation time 1.2 Estimation of biomass, calculation of specific growth rate, yield coefficient of Bacteria. 1.3 Estimation of biomass, calculation of specific growth rate, yield coefficient of Yeast.

2. Optimization of growth conditions – physical & chemical (pH, temperature, time, nutrients – carbon, nitrogen&phoshorous)

3. Determination of mass transfer coefficient 4. Glucose assay by dDNS method 5. Enzyme activity calculation 6. Immobilized by alginate gel method 7. TLC, Column chromatography, affinity chromatography, ion exchange chromatography, gel filtration

chromatography

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SATHYABAMA UNIVERSITY FACULTY OF BIO AND CHEMICAL ENGINEERING

M.E. / M.Tech REGULAR 44 REGULATIONS 2015

SBT 5202 NANOBIOTECHNOLOGY L T P Credits Total Marks

3 1 0 4 100

COURSE OBJECTIVE Introduces the students with the basics of nanotechnology that includes nanomaterials and devices. Elaborates

on the biological aspects of nanotechnology like synthesis methods and applications.

UNIT 1 INTRODUCTION 12 Hrs. Introduction to nano scale size – definition, concepts, history of development, types of approaches, 4 generation,comparative study of micro and nano technology (BIO-MEMS, NEMS), dimensions of nano science, nanomechanics,nano chemistry, nano electronics – principles and applications.

UNIT 2 PRODUCTION AND SYNTHESIS 12 Hrs. Production and synthesis of nano particle – physical, chemical, biological methods, nanoproperties,characterization, fabrication technology of nano size, fullerenes, colloidal gold, carbon - nano tube, quantum dots, nano wires, classification of nano structure materials. nnaopolmers

UNIT 3 BIOLOGICAL NANOSTRUCTURES 12 Hrs. Bacterial magnetsome, S-Layer, Bacteriorhodopsin, PHA, Cyanophycin inclusion, biological nano pore, nano motors and its applications, nano capsules, mediated drug delivery, principles of pharmconano medicine, nanoroboticsand its application, usage of gold nano particles in bio medical application.

UNIT 4 APPLICATION 12 Hrs. Recent trends and application of nano particles, Omni presents in different fields of research and development, environmental impact – dangerous, sudden and unexpected risk, economic impact, bioterrorism, nanopathology, Nano biochips

UNIT 5 TOXICITY 12 Hrs. Nano toxicity, Risks factors associated with nanoparticles-Eco toxicity- Effect on biotic components of the ecosystem-Methods for the evaluation of toxicity –in vitro and in Vivo methods.Possible methods to overcome toxicity-recent trends

Max. 60 Hours

TEXT / REFERENCE BOOKS 1. Jain, K.K, Nanobiotechnology in Molecular Diagnostics, Current Techniques and application, Taylor and Francis

Publications, 2006. 2. Salata O.V., Applications of Nanoparticles in Biology and Medicine, Journal of Nanobiotechnology, 2004.

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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M.E. / M.Tech REGULAR 73 REGULATIONS 2015

SBT 6536 PLANT AND ANIMAL BIOTECHNOLOGY LAB L T P C Total Marks 0 0 6 3 100

PLANT TISSUE CULTURE 1. Plant tissue culture media preparation 2. Direct organogenesis 3. Indirect organogenesis 4. Anther culture 5. Embryo culture 6. Somatic embryogenesis 7. Synthetic seeds 8. Protoplast culture 9. Agrobacterium mediated genetic transformation

ANIMAL TISSUE CULTURE 1. Preparation of culture media and reagents for primary culture and cell lines 2. Maintenance of cell line 3. Estimation of viability by dye exclusion 4. Preparation of cell in repository and cryopreservation 5. MTT-based cytotoxicity assay 6. Staining of cell line and observation 7. Estimation of protein in tissue culture fluid 8. Isolation of DNA from the cultured cells

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M. E. / M. Tech REGULAR 95 REGULATIONS 2015

SBI5618 BIOINFORMATICS (For M. Sc. BIOTECHNOLOGY)

L T P Credits Total Marks 3 1 0 4 100

COURSE OBJECTIVE Introduces the students on this interdisciplinary field where in knowledge about the usage of various algorithms

and computational techniques in solving biological problems

UNIT 1 INTRODUCTION 12 Hrs. Introduction to Bioinformatics: Overview and Definition - Need for Bioinformatics -Different fields in Bioinformatics. Sequence formats used in Bioinformatics databases and tools.

UNIT 2 DATABASES 12 Hrs. Biological Databases: Introduction. Biological Databases – Primary databases – Nucleic acids – NCBI, DDBJ,EMBL . Proteins – PIR, Swissprot. Secondary databases – PROSITE, PRINTS, PFAM. Structure classification databases– SCOP, CATH.

UNIT 3 SEQUENCE ANALYSIS 12 Hrs. Sequence Analysis: Introduction to sequence analysis and alignment. Pairwise and Multiple sequence alignment.Tools for sequence alignments - BLAST, FASTA, clustalW. Phylogenetic analysis – rooted and unrooted trees.

UNIT 4 PREDICTION 12 Hrs. Prediction studies: Introduction to protein structure - domains, motifs and their uses. Secondary structure prediction- tools used. Intoduction to 3D structure prediction - Homology modeling, Threading &Abinitio Methods. Gene prediction

UNIT 5 COMPUTER REQUIREMENTS 12 Hrs. Bibliographic Databases, WWW, Internet and its Uses in Bioinformatics.Introduction to computers: Introductionto computer architecture. Introduction to Operating Systems : Windows, LINUX / UNIX Operating System

Max. 60 Hours

TEXT / REFERENCE BOOKS 1. Arthur M. Lesk, Introduction to Bioinformatics; Oxford University Press, 2014. 2. Attwood T.K and Parry-Smith D J; Introduction to Bioinformatics, Pearson Education, 2001. 3. Andreas D Baxevanis, Francis B F ouellete; Bioinformatics-A practical guide to the analysis of genes and proteins, 2nd

Edition,John Wiley and sons,2004. 4. Jean Michel Claverie and Cedric Notrdame; Bioinformatics- A Beginner’s Guide, 2nd Edition, Wiley Dreamtech India Pvt.

Ltd., 2004.

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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SATHYABAMA UNIVERSITY FACULTY OF BIO AND CHEMICAL ENGINEERING

M. E. / M. Tech REGULAR 119 REGULATIONS 2015

SBT 5611 ENZYMES AND ENZYME KINETICS L T P Credits Total Marks

3 1 0 4 100

COURSE OBJECTIVE To understand the concepts of enzyme Structure and Mechanism of action including the factors effecting the

enzyme activity and applications of enzymes in Industry.

UNIT 1 INTRODUCTION TO ENZYMES 12 Hrs. Enzyme nomenclature and classification, Characteristics of enzymes- Concept of holoenzymes, coenzymes, apoenzyme, Substrate, Inhibitor, Activator, Modulators etc., Substrate Specificity- Lock and Key model, Induced fit model, factors influencing enzyme catalytic rates, Enzyme specificity - types and hypothesis involved, Methods of purification and concentration of intracellular and extracellular enzymes.

UNIT 2 ENZYME KINETICS 12 Hrs. Collision theory, Activation energy and transition state energy, The Law of Mass Action and Order of reaction. Kinetics of single - substrate enzyme catalyzed reactions- Derivation, Modification (Lineweaver Burk, Eadie-Hofstee, Hanes plots), Significance of Michaelis Menton equation.

UNIT3 FACTORS AFFECTING ENZYME ACTIVITY AND ENZYME REGULATION 12 Hrs. Factors influencing enzyme catalytic rates, Enzyme inhibition and kinetics – reversible and irreversible. Enzyme regulation- Allosteric modification of enzymes and Significance of sigmoidal kinetics, Feedback regulation, Covalent modification, proteolytic activation and degradation of enzymes.

UNIT 4 MECHANISM OF ENZYME ACTION 12 Hrs. Evidences for enzyme substrate complex. Nucleophilic and electrophilic attack. Investigation of Active site structure. Mechanisms of reactions catalysed by enzymes without cofactors - Eg:- Chymotrypsin, Ribonuclease, Lysozyme, Triose Phosphate Isomerase. Metal activated enzymes and Metalloenzymes, Coenzymes.

UNIT 5 ENZYME TECHNOLOGY 12 Hrs. Enzymes as analytical reagents - Principles of enzymatic analysis, Application of Enzymatic analysis in medicine and industry. Biotechnological applications of enzymes - Enzyme immobilization and applications, Biosensors.

Max. 60 Hours

TEXT / REFERENCE BOOKS 1. Trevor Palmer, Enzymes, Woodhead publishers.2001. 2. Lehninger, Nelson, Cox, Principles of Biochemistry, 3rd Edition, CBS publishers, 2002. 3. Voet et al., Fundamentals of Biochemistry, 2nd Edition, John Wiley and Sons, Inc, 1995. 4. Murray R.K., Granner D.K., Mayes P.A. and Rodwell V.W., Harper’s Biochemistry, Prentice - Hall International, 2001. 5. Ashok Pandey, Colin Webb, Carlos Ricardo Soccol, Christian Larroche, Enzyme Technology, Asiatech Publishers Inc., 2006.

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART 30 A : 6 Questions of 5 Marks each – No Choice Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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M. E. / M. Tech REGULAR 121 REGULATIONS 2015

SBT 5613 ENZYME ENGINEERING L T P Credits Total Marks

3 1 0 4 100

COURSE OBJECTIVE To import the basic knowledge of enzymes and their classification and reaction kinetics were specified. To

introduce the significance of enzymes regulation, inhibition and analysis of enzymes by instrumented methods also described.

UNIT 1 INTRODUCTION TO ENZYMES 12 Hrs. Enzyme nomenclature and classification, Characteristics of enzymes, Concepts of rate processes in biological systems, factors influencing enzyme catalytic rates, Enzyme specificity - types and hypothesis involved.

UNIT 2 ENZYME REACTION KINETICS 12 Hrs. Kinetics of single - substrate enzyme catalyzed reactions- Derivation, modification, significance of MichaelisMenton equation, LB plot, Eadie-Hofstee and Hanes plot, Haldane relationship. Rapid reaction kinetics - Pre-steady kinetics and relaxation kinetics. Multi-substrate enzyme catalyzed reactions - mechanism and steady state kinetics.

UNIT 3 ENZYME INHIBITION AND REGULATION 12 Hrs. Enzyme inhibition and kinetics – reversible and irreversible. Competitive, uncompetitive, non-competitive, mixed, partial, substrate and allosteric inhibitions.

UNIT 4 ENZYME CATALYSIS 12 Hrs. Mechanisms of catalysis, mechanisms of reactions catalysed by enzymes without cofactors, metal-activated enzymes and metalloenzymes, the involvement of coenzymes in enzyme-catalyzed reactions. Sigmoidal kinetics - Monod-Wyman-Changeux model, Koshland-Nemethy-Filmer model.

UNIT 5 INSTRUMENTATION FOR ENZYMATIC ANALYSIS 12 Hrs. Principles of the available detection techniques – manometry, spectrophotometry, spectrofluorimetry, electrochemical methods, enthalpimetry, radiochemical methods, dry-reagent techniques. Automation in enzymatic analysis – fixed time methods, fixed concentration methods and methods involving continuous monitoring.

Max. 60 Hours

TEXT / REFERENCE BOOKS 1. Trevor Palmer, Enzymes, Woodhead publishers.2001. 2. Lehninger, Nelson, Cox, Principles of Biochemistry, 3rd Edition, CBS publishers, 2002. 3. Voet et al., Fundamentals of Biochemistry, 2nd Edition, John Wiley and Sons, Inc, 1995. 4. Murray R.K., Granner D.K., Mayes P.A. and Rodwell V.W., Harper’s Biochemistry, Prentice - Hall International, 2001. 5. Wiseman, A: Handbook of Enzyme Biotechnlogy, 3rd Edition, Ellis Horwood Publication, Chichester, 1985.

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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SATHYABAMA UNIVERSITY FACULTY OF BIO AND CHEMICAL ENGINEERING

M. E. / M. Tech REGULAR 122 REGULATIONS 2015

SBT5614 PHARMACEUTICAL BIOTECHNOLOGY (For M.Sc)

L T P Credits Total Marks 3 1 0 4 100

COURSE OBJECTIVE To provide wide knowledge about pharmaceutical bioproducts, microbial conversion and Recombinant microbial technology.

UNIT 1 INTRODUCTION 12 Hrs. History of pharmaceutical Industry. Drug discovery and development process. Sources of therapeutic molecules. Specific Fermentations: Selection of organism, fermentation & purification of various antibiotics: like penicillin, streptomycin, tetracycline, erythromycin; Vitamins: riboflavin, cyanocobalamin,

UNIT 2 BIOTRANSFORMATION 12 Hrs. Microbial Transformations: Types, Methods of bioconversions & Application in Pharma Industry, Steroidal transformation. Hairy root culture in biotransformation.

UNIT 3 RECOMBINANT TECHNOLOGY IN PHARMACEUTICAL INDUSTRIES 12 Hrs. Recombinant DNA Technology: Introduction to rDNA technology and genetic engineering, steps involved, isolation of enzymes, vectors, recombination and cloning of genes. Production of bio technology derived therapeutic proteinslikehumulin, humatrop, activase, intron a, monoclonal antibodies by hybridoma technique, recombivax HB(hepatitis b)

UNIT 4 DRUG DOSAGE FORMS 12 Hrs. Drug dosage forms.Immunology& Immunological Preparations: Principles of Immunity, Humoral immunity, cell mediated immunity,antigen – antibody reactions, hypersensitivity and its applications. Active & passive immunizations vaccine preparation,standardization& storage of polio, tetanus toxoid, immuno serum & diagnostic agents. Pharmacokinetics of DNA and protein drugs.

UNIT 5 QUALITY CONTROL AND DRUG SAFETY 12 Hrs. Characterization and quality control of biotechnology derived products: Purification , characterization and analysis,establishing safety and efficacy, impurities present in biotechnology derived products, foreign contaminants, heterogeneityof protein analytical technique (Gel electrophoresis, HPLC / FPLC, tryptic mapping, N-terminal sequencing,ultracentrifugation) immunoassay, bioassay, stability requirements.

Max. 60 Hours

TEXT / REFERENCE BOOKS . Gary Walsh, Biopharmaceuticals: Biochemistry & Biotechnology, John Wiley & Sons Ltd., 1998. 2. Leon 1Lachman, Theory and Practice of Industrial Pharmacy, 3rd Edition, Lea and Febiger, 1986. 3. Remington’s Pharmaceutical Sciences, 17th Edition, Mark Publishing and Company, 1985.

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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SATHYABAMA UNIVERSITY FACULTY OF BIO AND CHEMICAL ENGINEERING

M. E. / M. Tech REGULAR 123 REGULATIONS 2015

SBT 5615 STEM CELL RESEARCH

(For M.Sc) L T P Credits Total Marks

3 1 0 4 100

COURSE OBJECTIVE Discusses the fundamental concepts in stem cell research that includes various types of stem cells and their

applications

UNIT 1 INTRODUCTION 12 Hrs. Embryonic development, Evolution of stem cell, Stem cell niche, cell cycle regulation of stem cell, Genetic regulation of stem cell fate. Potential applications for stem cell research. Origin and characterisation of human stem cells, plasticity of human somatic stem cell, stem cell based therapies, scientific and technical obstacles to overcome before realising the potential clinical use of novel human stem cell based therapy, cord blood, stem cell marker.

UNIT 2 HUMAN EMBROYONIC STEM CELL 13 Hrs. Human embroyonic stem cell research: Possible sources for human embryonic stem cell, Growing human ESC in laboratory, Current advantages and limitations of hESC and human somatic cells, Examination the need for new cell lines, Developments regarding establishment of human stem cell banks and registries. Government of hESC research, Ethical issues in human embryonic stem cells.

UNIT 3 NEURAL STEM CELLS 10 Hrs. Neurosphere-sources, isolation, differentiation, Differentiation of cells from human, neurospheres into neurons, astrocytes and oligodentrocytes; Immuno labeling procedure, Therapeutic applications-recent trends

UNIT 4 APPLICATIONS OF STEM CELLS 13 Hrs. Gene therapy: Possibilities to overcome immuno - rejection in stem cell therapy, Haematopoietic stem cell transplantation-A new therapy for autoimmune disease, Hematopoietic stem cell mobilization, Isolation and characterization of stem cell, Prenatal diagnosis of genetic abnormalities using fetal CD34+ stem cells. Stem cells in treatment for major disease and reparative medicine, Germ – line therapy.

UNIT 5 TISSUE ENGINEERING 12 Hrs. Recent trends in Tissue Engineering: Basic principles and consideration- cell type and source, metabolic requirements of cells, scaffolds-selection and application. Tissue engineering of the liver, heart, kidney, ethical issues in tissue engineering.

Max.60 Hours

TEXT / REFERENCE BOOKS 1. Kursad Turksen. Embryonic Stem cells, Humana Press. 2002. 2. Stem cell and future of regenerative medicine. By committee on the Biological and Biomedical applications of Stem cell

Research, National Academic Press, 2002.

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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M. E. / M. Tech REGULAR 124 REGULATIONS 2015

SBT 5616 ANALYTICAL TECHNIQUES IN

BIOTECHNOLOGY L T P Credits Total Marks

3 1 0 4 100

COURSE OBJECTIVE Discusses the various instrumental techniques involved in biotechnological research along with the principle and

applications. It includes concepts on microscopy, chromatography and spectroscopy

UNIT 1 SEPARATION AND MICROSCOPIC TECHNIQUES 13 Hrs. Cell disruption methods and Cell fractionation - High pressure homogenization, Ultrasonication - Protein precipitation. Centrifugation : Principle, types and applications-Differential, isopycnic density gradient centrifugation, Rate zonal centrifugation. Microscopy – Bright field , Dark field , Phase contrast, Fluorescence, Scanning and transmission electron microscopy - Flow cytometry.

UNIT 2 SPECTROSCOPY AND CHROMATOGRAPHY 13 Hrs. Spectroscopy – Principle and applications - UV-Visible spectrophotometer - Infrared Red ,Fluoroscence Spectrophotometry, Atomic Absorption Spectrophotometry - Mass Spectrometry, NMR and ESR. Chromatography : Principle, methods and applications- TLC, Column Chromatography - Ion exchange , Gel Filtration and Affinity Chromatography, HPLC and GC

UNIT 3 MOLECULAR TECHNIQUES 12 Hrs. Electrophoresis of nucleic acid and proteins : Principles, methods and applications- Agarose gel electrophoresis, Pulse field gel electrophoresis, , SDS – PAGE, IEF, 2D PAGE. Blotting techniques - principle, methods and applications - Southern, Northern, Western blotting. PCR and its types. Immunological techniques - Immunoelectrophoresis- ELISA, RIA.

UNIT 4 TRACER TECHNIQUES 12 Hrs. Tracer techniques- autoradiography , XRD. Immobilization of cells and enzymes - Nano biotechnology in molecular diagnosis: current techniques and applications- Biosensors- principle, methods and applications in biotechnology- Biochips technology.

UNIT 5 SAFETY GUIDELINES 10 Hrs. Aseptic techniques , Safety guide lines for rDNA research, containment facility and its disposal : laboratory, industrial and environmental applications. Microbiological analysis – Microbial evaluation- Air monitoring- Basics of microbial identificaion

Max. 60 Hours

TEXT / REFERENCE BOOKS 1. Wilhard, Instrumental methods in Chemical analysis, 5th Edition, D Van Nostrand, New York, 1974. 2. Skoog DA, Principles of Instrumental Analysis, Thomas Pvt Ltd, 6th Edition, Van Nostrand, Newyork 1981. 3. Keith Wilson and John Walker, Practical Biochemistry - Principles and Techniques, 5th Edition, Cambridge University Press,

2003. 4. Biophysical chemistry : Principles and Techniques – Upadhayay and Nath – Himalaya publishing house , 2nd Review Edition

, 2009.

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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M. E. / M. Tech REGULAR 125 REGULATIONS 2015

SBT 5617 CANCER BIOLOGY (For M.Sc)

L T P Credits Total Marks 3 1 0 4 100

COURSE OBJECTIVE Provides detailed information on types of cancer, types of cancer cells, genetics in cancer and therapeutics

involved.

UNIT 1 INTRODUCTION 12 Hrs. Cancer, Salient Features of cancer- causes of cancer –Neoplasia, hypoplasia nad metaplasia- carcinogens, physical,chemical and Biological Oncogenic viruses- Classification of cancer- Epidemiology of human cancer.

UNIT 2 MECHANISM 12 Hrs. Malingancy- Characteristics of malignant cells- Molecular mechanism - modification of extacellular matrix component cells – Extacellular matrix and cell – cell adhesion, cell cycle regulation, Apoptosis, Growth factor, signal transduction, mechanism of angiogenesis, biology of human metastasis.

UNIT 3 GENETICS OF CANCER 12 Hrs. Cancer and genetics- Chromatin structure and function, Split genes and RNA processing, genetic recombination, gene amplification, DNA methylation, Genomic imprinting, oncogenes, Tumor suppressor genes, mechanism of gene silencing, Gene therapy of cancer

UNIT 4 DIAGNOSTIC METHODS 12 Hrs. Methods for the diagnosis - Tumor markers, Gene expression microarray, proteomic method, Molecular imaging, Nanotechnology, Pharmacogenomics.

UNIT 5 THERAPY 12 Hrs. Cancer therapy- Diet and cancer prevention, Chemotherapy - Molecular targets of chemoprevention, Immunotherapy, Radiation therapy: Advantages and limitation.

Max. 60 Hours

TEXT / REFERENCE BOOKS 1. Maly B.W.J .Virology: A Practical approach IRL Press, Oxford, 1987 2. Dunmock N.J and Primrose S.B; Introduction to Modern Virology, Blackwell Scientific publication, Oxford, 1988 3. Margaret A. Knowles, Peter J Selby, An Introduction to Cellular and Molecular Biology of Cancer, 4th Edition, Oxford Medical

Publication, 1991

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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M. E. / M. Tech REGULAR 126 REGULATIONS 2015

SBT 5618 ENVIRONMENTAL BIOTECHNOLOGY (For M.Sc)

L T P Credits Total Marks 3 1 0 4 100

COURSE OBJECTIVE Discusses on the various types of pollution and their treatment methods. Also briefs on the remediation

technologies and bioenergy production

UNIT 1 INTRODUCTION TO ENVIRONMENTAL POLLUTION 12 Hrs. Air, water and soil pollution- common effects and control measures. Microbial flora of soil,Interactions among soil microorganisms ,biogeochemical role of soil microorganisms

UNIT 2 WASTE TREATMENT 12 Hrs. Biological treatment system- (Oxidative ponds, aerobic and anaerobic ponds, facultative ponds, aerated ponds), Trickling filter, activated sludge treatment, anaerobic digestion. Treatment scheme of Drinking water, solid waste management.Air pollution control techniques. UNIT 3 BIOREMEDIATION 12 Hrs. Insitu and exsitu,Biostimulation, Bioaugmentation, Phytoremediation. Composting, Bioventing &Biosparging.role of GEM in oil recovery

UNIT 4 BIODEGRADATION OF XENOBIOTICS 12 Hrs. Biodegradation of Xenobiotics. Metal microbe interactions: Heavy Metal Pollution and impact on environment, Microbial Systems for HeavyMetal Accumulation, Biosorption, Biological metal precipitation, bioleaching- advantages and disadvantages

UNIT 5 BIOENERGY 12 Hrs. (Biogas), Hydrogen, Alcohols and algal hydrocarbons, biofertilizer, biopesticide, organic farming

Max. 60 Hours

TEXT / REFERENCE BOOKS 1. Alan Scragg, Environmental Biotechnology, Longman, 1999. 2. Milton Wainwright, An Introduction to Environmental Biotechnology, Kluwer Academic Press, 1999.

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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M. E. / M. Tech REGULAR 127 REGULATIONS 2015

SBT 5619 MARINE BIOTECHNOLOGY

(For M.Sc) L T P Credits Total Marks

3 1 0 4 100

COURSE OBJECTIVE Introduces the marine environment and the various marine products that are industrially significant.

UNIT 1 INTRODUCTION TO MARINE ENVIRONMENT AND BIODIVERSITY 12 Hrs. Physical and Chemical properties of sea water. Zonation of sea: Euphotic – mesopelagic – bathopelagic- benthos - deep sea. Marine ecosystems and biodiversity: Diversity & adaptation. Marine microbial diversity: Marine microbial habitats - Microbial distribution in the oceans - Factors that impact marine microbial diversity - Interactions between marine microbes and macroorganisms - Symbiotic relationship with marine invertebrates - Marine viruses.

UNIT 2 AQUACULTURE 12 Hrs. Aquaculture: Definition - Importance of aquaculture-Criteria of selection of species for aquaculture. Types of culture: Monoculture, polyculture, composite fish culture and integrated fish farming. Culture practices of marine fishe (seabass), Pacific white shrimp , Freshwater prawn, crab, lobsters, edible oyster, and Seaweeds.

UNIT 3 FISH GENETICS AND BIOMEDICAL IMPORTANCE OF MARINE ORGANISMS 12 Hrs. Fish genetics: Gynogenesis, androgensis, polyploidy, artificial insemination, eye stalk ablation. cryopreservation.Live feed culture: microalgae and Artemia - Biofuel production by marine plankton- Marine enzymes - HUFA, PUFA, and Omega-3 Fatty acid from marine organisms. New antibiotics and medicines from marine organisms. Secondary metabolites from marine cyanobacteria, actinomycetes and endophytic fungi – Probiotics.

UNIT 4 MARINE VALUE ADDED PRODUCTS 12 Hrs. Fish meal, Fish sausages, Isinglass, Fin rays, Chitosan, Chitin Pearl essence, Agar, Alginates, Carrageenan. Useful products from Trash fish.

UNIT 5 ENVIRONMENTAL IMPACTS OF AQUATIC BIOTECHNOLOGY 12 Hrs. Human impacts on marine microbial diversity - Using marine microbes to ameliorate environmental deterioration. Control of oil spills and bioremediation. Environmental issues: Effects of bio-fouling and bio-deterioration on marine structures. Protection methods against corrosion and fouling. Red tides: Causative factors and effects on the organisms of marine environment.

Max. 60 Hours

TEXT / REFERENCE BOOKS 1. Pillay, T.V.R, Aquaculture Principles & Practices. Fishing News (Books) Limited, London, 1990. 2. Santhanam R. N. Ramanathan and G. Jegatheesan, Coastal Aquaculture in India, CBS publishers, 1990. 3. Le Gal, Y., Ulber, R, Marine Biotechnology I :Advances in Biochemical Engineering/Biotechnology (Series editor: T. Scheper)

Springer-Verlag Berlin Heidelberg.Vol. 96. pp. 287, 2005. 4. Le Gal, Y., Ulber, R, Marine Biotechnology II: Advances in Biochemical Engineering/Biotechnology (Series editor: T.

Scheper) Springer-Verlag Berlin Heidelberg.Vol. 97. pp. 261, 2005. 5. Jennie Hunter-Cevera, David Karl and Merry Buckley, Marine microbial diversity: The key to earth's habitability: A Report

from the American academy of microbiology, Published by American Academy of Microbiology, held (April 8- 10, 2005) in San Francisco, California. pp. 28, 2005.

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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M. E. / M. Tech REGULAR 128 REGULATIONS 2015

SBT 5620 BIOSAFETY, BIOETHICS AND IPR

(For M.Sc) L T P Credits Total Marks

3 1 0 4 100

COURSE OBJECTIVE Discusses on the general concepts on IPR and patents and bioethics in industry

UNIT 1 BIOSAFETY 12 Hrs. Introduction, biosafety issues in biotechnology – historical background; Introduction to biological safety cabinets; Biosafety levels, primary containment for biohazards.Biopsafety levels of specific microorganisms; recommended biosafety levels for infectious agents and infected animals.

UNIT 2 BIOSAFETY GUIDELINES 12 Hrs. Biosafety guidelines and regulations (National and International) – operation of biosafety guidelines and regulations of Government of India; Definition of GMO’s and LMO’s; Roles of institutional biosafety committee, RCGM, GEAC, etc., for GMO applications in food and agriculture. Environmental release of GMO’s, risk analysis, risk assessment, risk management and communication.

UNIT 3 INTELLECTUAL PROPERTY RIGHTS 12 Hrs. Types of IP; Patents, TradeMarks, Copyright & related rights, Industrial design, Traditional knowledge, Geographical indications – importance of IPR. Patent filing procedures – national and PCT filing procedure. Intellectual properties of relevance to biotechnology.

UNIT 4 AGREEMENTS AND TREATIES 12 Hrs. History of GATT and TRIPS agreement; Madrid agreement; Hague agreement; WIPO treaties; Budapest treaty; PCT; Indian patent Act 11270 and recent amendments. Role of a Country Patent Office. Patent infringement – meaning, scope, litigation.

UNIT 5 BIOETHICS 12 Hrs. Research ethics. Framework for ethical decision making; biotechnology and ethics, biowarfare and biopiracy. Introduction to animal ethics, animal rights and use of animals.

Max. 60 Hours

TEXT / REFERENCE BOOKS 1. Mike Martin and Roland Schinzinger, Ethics in Engineering, McGraw Hill, 2005. 2. Kankanala C, Genetic Patent law and Strategy, First edition, Manupatra Information solution Pvt.Ltd.,2007. 3. Sasson A, Biotechnologies in developing countries present and future, UNESCO Publishers, 1993. 4. Singh K, Intellectual Property Rights on Biotechnology, Kalyani Publication, 2nd Edition, 2008. 5. Edmund G Seebauer and Robert L Barry, “Fundamentals of Ethics for Scientists and Engineers”, Oxford University Press,

2001.

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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SATHYABAMA UNIVERSITY FACULTY OF BIO AND CHEMICAL ENGINEERING

M. E. / M. Tech REGULAR 129 REGULATIONS 2015

SBT5621 BIOSTATISTICS L T P Credits Total Marks

3 1 0 4 100

COURSE OBJECTIVE Incorporates knowledge to the students on applying the statistical calculations in solving biotechnological

problems.

UNIT 1 INTRODUCTION TO STATISTICS 12 Hrs. Statistics and Biostatistics, Population and sample, Sampling theories, Variables, Collection, organization and presentation of data

UNIT 2 FREQUENCY DISTRIBUTION 14 Hours Frequency distribution: Discrete, Continuous and Cumulative. Measures of Central Tendency: Mean, Median, Mode, Geometric mean and Harmonic Mean, Measures of Dispersion: Range, Quartile Deviation, Mean Deviaion and Standard Deviation, Correlation and Regression

UNIT 3 PROBABILITY DISTRIBUTION 10 Hrs. Probability theory, Types of Probability, Probability Distributions: Binomial, Poisson and Normal,

UNIT 4 SAMPLING AND SAMPLING DISTRIBUTION 10 Hrs. Sampling methods, Hypothesis testing, Sampling distribution, Standard error, Type I and Type II errors, Level of Significance

UNIT 5 TEST OF SIGNIFICANCE 14 Hours Test of significance for: attributes and variables (Large samples and Small samples) – Chi square test for goodness of fit and independence of attributes, Student’s t test for single mean, paired t test, z test for single mean, two sample means. Analysis of variance – one way classification and two way classifications

Max. 60 Hours

TEXT / REFERENCE BOOKS 1. Palanichamy S and Manoharan M, Staistical methods for biologists, PalaniParamunt publications, 1999 2. Gurumani N, An introduction to Bistatistics, 2nd Revised Edition, MJP Publishers, 2005

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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SATHYABAMA UNIVERSITY FACULTY OF BIO AND CHEMICAL ENGINEERING

M. E. / M. Tech REGULAR 130 REGULATIONS 2015

SBT5622 GMP AND QUALITY CONCEPTS L T P Credits Total Marks 3 1 0 4 100

COURSE OBJECTIVE To introduce students about Good manufacturing practices quality concepts which would expose them to

industrial scenario.

UNIT 1 INTRODUCTION 12 Hrs. Basic Concepts: Quality concepts, Quality Control, Quality Assurance, Good Manufacturing Practices, Good Laboratory Practices, Responsibilities. Quality Control: Quality control laboratory: Responsibilities, good laboratory practices, routine controls, instruments, protocols, non-clinical testing, controls on animal house, data generation and storage, quality control documents, retention samples, records, audits of quality control facilities.

UNIT 2 GMP 12 Hrs. Good Manufacturing Practice. Legal requirements pertaining to GMP: GMP Guidelines, Standards, Regulatory agencies c) Basic Components of GMP: Organization & Personnel, Premises, Equipments, Raw Materials, Control on Manufacturing of dosage forms, Packaging and labeling control, Laboratory controls, Finished product release, Warehousing, Distribution and distribution records, waste and scrap disposal, Complaints and recalls, Specifications, Self inspection.

UNIT 3 GLP 12 Hrs. Good Laboratory Practice (GLP) – an overview and basic information, Scope. Principles of GLP: Test Facility Organization and Personnel, Quality Assurance Programme, Facilities, Apparatus, Material, and Reagents, Test Systems, Test and Reference Items, Standard Operating Procedures, Performance of the Study, Reporting of Study Result, Storage and Retention of Records and Materials. Responsibilities in GLP. Implementing of GLP in non GLP analytical laboratory.

UNIT 4 INSPECTION 12 Hrs. Inspections, Quality Audit and Quality System Reviews: Inspections of pharmaceutical manufacturers, role of quality audit, role of inspectors, methods of inspection- routine, concise, follow-up and special inspections, frequency and duration of inspections, preparations for inspections, conduct, report and regulatory actions. Loan License Auditing – Concepts, Auditing, role of quality circle in quality assurance.

UNIT 5 REGULATION 12 Hrs. Regulatory bodies – Need and role of regulatory bodies. Different regulatory bodies – FDA, HACCP and their scope. Importance of regulatory approval. ISO 9000 – regulations with reference to food and pharmaceutical industry.

Max. 60 Hours

TEXT / REFERENCE BOOKS 1. Sidney H. Willig, Good manufacturing Practices for Pharmaceuticals, 5th Edition, Revised and Expanded, Marcel Dekker,

Inc. New York, 2005. 2. Jose Rodriguez-Perez, The FDA and Worldwide Current Good Manufacturing Practices and Quality System requirements

guidebook for finished pharmaceuticals, American Society for Quality, ASQ Quality Press, Milwaukee, Wisconsin, 2014.

END SEMESTER EXAMINATION QUESTION PAPER PATTERN Max. Marks : 80 Exam Duration : 3 Hrs. PART A : 6 Questions of 5 Marks each – No Choice 30 Marks PART B : 2 Questions from each unit of internal choice, carrying 10 Marks each 50 Marks

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