VTU Bio-Technology 8th Semester Syllabus

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Download VTU Bio-Technology Syllabus Soft Copy

VTU Bio-Technology 8th Semester Syllabus

PROJECT MANAGEMENT & IPR
Sub. Code : 10BT-81

I.A Marks : 25
Hours/week : 04 Exam Hrs. : 03
Total Hours : 52 Exam Marks : 100

PART A

UNIT 1:
INTRODUCTION
Definitions, network planning techniques, benefits and limitations of network planning, project reporting, case studies. 02 Hours

UNIT 2:
PROJECT PLANNING
Planning procedures, developing a network planning diagram, project evaluation and review techniques. Developing the project schedule: scheduling procedure, timing estimates, manual timing calculations, optional start and finish times, tabulating the schedule, setting up the calendar schedule, constructing the bar chart time, schedule. Monitoring and controlling the project: constructing the progress schedule constructing the summary bar chart, constructing the project status report, status reporting using the milestone approach. Scheduling and Controlling Project Costs: Developing the Project Cost Schedule Monitoring Project Costs. Cost Minimizing: Time/Cost Trade-Offs, Planning Personnel/Labor Requirements, Need for Planning Personnel/Labor, Planning Personnel Requirements, Early Start Scheduling. 12 Hours

UNIT 3:
ROLE OF THE COMPUTER
Software Packages, features of a Project Management Package, Background Planning the Project Scheduling the Project, Monitoring the Project Schedule, Controlling Project Costs, Planning for Labor and Personnel, Using the Computer for Planning and Scheduling. 06 Hours

UNIT 4:
MANAGEMENT SYSTEM
Background developing a plan of action, conducting the audit, preparing the feasibility report, obtaining management approval, planning and scheduling project implementation, procuring, installing, and trying out the equipments, designing and constructing the site 06 Hours

PART B

UNIT 5:
IPR
Introduction to IPR, Concept of Property, Mar’x theory on Property, Constitutional aspects of Intellectual property. Basic principles of Patent laws: Historical background in UK, US and India. Basis for IP protection. Criteria for patentability: Novelty, Utility, and Inventive step, Non obviousness, Non patentable invention. 06 Hours

UNIT 6:
CONVENTIONS & AGREEMENTS
Paris convention (1883), Berne convention for protection of literary and artistic works (1886), Patent Corporation Treaty (PCT), Madrid agreement (1891) and protocols of relative agreement 1989). Rome convention (1961) on the protection of performances, producers of phonograms and Broadcasting organization, TRIPS agreement (1994), WIPO performance and phonograms Treaty (WPPT, 1996). 06 Hours

UNIT 7:
PATENT LAWS & BT
Objectives, Evolution of Biotechnology, Application of Biotechnology, Commercial potential of BT invention, R & D investments, Rationale and applications. Concept of Novelty and Inventive step in BT, Micro organisms and BT inventions, Moral issues in patenting BT invention. Substantiation of Patent laws & international agreements related to pharma, microbial, environmental, agricultural and informatics sectors via classical case studies. 06 Hours

UNIT 8:
TRADITIONAL KNOWLEDGE
Introduction, Justification for plant variety protection, International position, UPOV, 1961, 1978, 1991 guidelines, Plant variety protection in India. Justification for geographical indications, Multi-lateral treaties. Concept of Traditional knowledge, stake holders, issues concerning traditional knowledge, Bioprospecting & Biopyracy – ways to tackle, Protectability of traditional knowledge under existing IP framework, need for sui-generis regime, Traditional knowledge on the International arena, Traditional knowledge at WTO and National level, Traditional knowledge digital library. 08 Hours

TEXT BOOKS

  • The Law & Strategy of Biotechnology Patents by Sibley Kenneth.
  • Intellectual Property by Bently and Lionel, Oxford University Press.
  • Cases and Materials on Intellectual Property by Cornish, W R.
  • Project Management by Sahni, Ane Books.
  • Project Management for Business & Engineering: Principles and Practice by John M Nicholas, Elsevier.
  • Project Management for Business & Technology, Nicholas, PHI.
  • Practical Approach to IPR by Rachana Singh Puri, IK Intl. Ltd.

REFERENCE BOOKS
Refer Syllabus Book

BIOETHICS & BIOSAFETY
Sub. Code : 10BT-82

I.A Marks : 25
Hours/week : 04 Exam Hrs. : 03
Total Hours : 52 Exam Marks : 100

PART A

UNIT 1:
BIOTECHNOLOGY AND SOCIETY
Introduction to science, technology and society, issues of access-Case studies/experiences from developing and developed countries. Ownership, monopoly, traditional knowledge, biodiversity, benefit sharing, environmental sustainability, public vs. private funding, biotechnology in international relations, globalization and development divide. Public acceptance issues for biotechnology: Biotechnology and hunger: Challenges for the Indian Biotechnological research and industries. 08 Hours

UNIT 2:
LEGAL ISSUES
The legal, institutional and socioeconomic impacts of biotechnology; biotechnology and social responsibility, Public education to increase the awareness of bioethics with regard to generating new forms of life for informed decision making – with case studies. 04 Hours

UNIT 3:
BIOETHICS
Principles of bioethics: Legality, morality and ethics, autonomy, human rights, beneficence, privacy, justice, equity etc. The expanding scope of ethics from biomedical practice to
biotechnology, bioethics vs. business ethics, ethical dimensions of IPR, technology transfer and other global biotech issues. 06 Hours

UNIT 4:
BIOSAFETY CONCEPTS AND ISSUES
Ethical conflicts in biotechnology – interference with nature, fear of unknown, unequal distribution of risks and benefits of biotechnology, Rational vs. subjective perceptions of risks and benefits, relationship between risk, hazard, exposure and safeguards, Biotechnology and biosafety concerns at the level of individuals, institutions, society, region,
country and the world. The Cartagena protocol on biosafety. Biosafety management. Ethical implications of biotechnological products and techniques. 08 Hours

PART B

UNIT 5:
BIOSAFETY IN THE LABORATORY
Laboratory associated infections and other hazards, assessment of biological hazards and levels of biosafety, prudent biosafety practices in the laboratory/ institution. Experimental protocol approvals, levels of containment. 04 Hours

UNIT 6:
REGULATIONS
Biosafety assessment procedures in India and abroad. International dimensions in biosafety, bioterrorism and convention on biological weapons. Social and ethical implications of biological weapons. Biosafety regulations and national and international guidelines with regard to recombinant DNA technology. Guidelines for research in transgenic plants. Good manufacturing practice and Good lab practices (GMP and GLP). National and international regulations for food and pharma products. 08 Hours

UNIT 7:
ECOLOGICAL & FOOD SAFETY
The GM-food debate and biosafety assessment procedures for biotech foods & related products, including transgenic food crops, case studies of relevance. Key to the environmentally responsible use of biotechnology. Environmental aspects of biotech applications. Use of genetically modified organisms and their release in environment. 06 Hours

UNIT 8:
AGRI & PHARMA SECTOR
Discussions on recombinant organisms and transgenic crops, with case studies of relevance. Plant breeder’s rights. Legal implications, Biodiversity and farmers rights. Biosafety assessment of pharmaceutical products such as drugs/vaccines etc. Biosafety issues in Clinical Trials. 08 Hours

TEXT BOOKS

  • Biotechnology and Safety Assessment by Thomas, J.A., Fuch, R.L, Academic Press.
  • Biological safety Principles and practices) by Fleming, D.A., Hunt, D.L, ASM Press.
  • Biotechnology – A comprehensive treatise. Legal economic and ethical dimensions VCH.
  • Bioethics by Ben Mepham, Oxford University Press.
  • Bioethics & Biosafety by R Rallapalli & Geetha Bali, APH Publication.

REFERENCE BOOKS
Refer Syllabus Book

ELECTIVE D
NANOBIOTECHNOLOGY
Sub. Code : 10BT-831

I.A Marks : 25
Hours/week : 04 Exam Hrs. : 03
Total Hours : 52 Exam Marks : 100

PART A

UNIT 1:
INTRODUCTION
A Brief History of the Super Small, Definition of nanotechnology, Nanobiotechnology; Discussions on nanofabrication, Bottom-Up versus Top-Down; Nanolithography,
Microelectronic fabrication, Structure-property relationships in materials, biomolecule-surface interactions. Fabrication in Hard Materials: Silicon and glass materials for nano- and microfabrication, Fabrication in Soft Materials: Hydrogels/PDMS/other polymers and base materials for nano- and microfabricated devices. 08 Hours

UNIT 2:
NANOMATERIALS AND THEIR CHARACTERIZATION
Buckyballs, Nanotubes, Fullerenes, Carriers, Dendrimers, Nanoparticles, Membranes / Matrices, Nanoshells, Quantum Dot, Nanocrystals, hybrid biological/inorganic devices, Scanning tunneling microscopy, Atomic force microscopy, DNA microarrays. 06 Hours

UNIT 3:
BIONANOMATERIALS
Function and application of DNA based nanostructures. In-vitro laboratory tests on the interaction of nanoparticles with cells. Assessment of the toxic effects of nanoparticles based on in-vitro laboratory tests. Identification of pathogenic organisms by magnetic nanoparticle-based techniques. 06 Hours

UNIT 4:
NANODIAGNOSTICS
Diagnostics and Sensors, Rapid Ex-Vivo Diagnostics, Nanosensors as Diagnostics, Nanotherapeutics. Nanofabricated devices to separate and interrogate DNA, Interrogation of
immune and neuronal cell activities through micro- and nanotechnology based tools and devices. 06 Hours

PART B

UNIT 5:
DRUG DISCOVERY AND DRUG DELIVERY
Drug Discovery Using Nanocrystals, Drug Discovery Using Resonance Light Scattering (RLS) Technology. Benefits of Nano-Imaging Agents, Nanosensors in Drug Discovery, Drug Delivery using Nanobiosensors, Drug Delivery Applications, Bioavailability, Suistained and targeted release, Nanorobots, Benefits of Nano-Drug Delivery. Drug Delivery, Health Risks, and Challenges, Targeting. Drug Delivery Revenues. Use of microneedles and nanoparticles for local highly controlled drug delivery. 08Hours

UNIT 6:
MICROFLUIDICS
Laminar flow, Hagen-Poiseullie eqn, basic fluid ideas, Special considerations of flow in small channels, mixing, microvalves & micropumps, Approaches toward combining living cells, microfluidics and ‘the body’ on a chip, Chemotaxis, cell motility. Case Studies in Microfluidic Devices. 06 Hours

UNIT 7:
BioMEMS – INTRODUCTION
Introduction and Overview, Biosignal Transduction Mechanisms: Electromagnetic Transducers Mechanical Transducers, Chemical Transducers, Optical Transducers – Sensing and Actuating mechanisms (for all types). 06 Hours

UNIT 8:
BioMEMS – APPLICATIONS
Case Studies in Biomagnetic Sensors, , Applications of optical and chemical transducers. Ultimate Limits of Fabrication and Measurement, Recent Developments in BioMEMS.
06 Hours

TEXT BOOKS, REFERENCE BOOKS
Reder Syllabus Book

LAB TO INDUSTRIAL SCALING
Sub. Code : 10BT-832

I.A Marks : 25
Hours/week : 04 Exam Hrs. : 03
Total Hours : 52 Exam Marks : 100

PART A

UNIT 1:
INTRODUCTION
Fermentation as a Biochemical process, Microbial biomass, Enzymes, Metabolites recombinant products. 04 Hours

UNIT 2:
INDUSTRIALLY IMPORTANT MICROBES
Isolation of industrially important microorganisms preservation of microbes, Strain development by various methods, Isolation of mutants and recombinants, application of continuous, batch and fed batch culture. 08 Hours

UNIT 3:
RAW MATERIALS AND STERILIZATION
Selection of typical raw materials, Different media for fermentation, Optimization of media, Different sterilization methods – batch sterilization, continuous sterilization, filter sterilization, Oxygen requirement. 08 Hours

UNIT 4:
PREPARATION OF INOCULUM
Inoculum preparation from laboratory scale to pilot scale and large scale fermentation, maintenance of aseptic condition. 06 Hours

PART B

UNIT 5:
DESIGN OF FERMENTERS
Basic structure of fermenter body construction. Description of different parts of fermenter aseptic conditions. Different types of fermenters. 05 Hours

UNIT 6:
PROCESS CONTROL
Instruments involved in the fermentation, control of pressure, temperature, flow rate, agitation, stirring, foaming. Online analysis for measurement of physico chemical and biochemical parameters. Method of online and off line bio mass estimation. Flow injection analysis for measurement of substrates products and other metabolites, computer based data acquisition. 08 Hours

UNIT 7:
AREATION AND AGITATION
Supply of oxygen, fluid rheology, factors affecting aeration and agitation. Scale up and scale down of aeration and agitation. 05 Hours

UNIT 8:
INDUSTRIAL OPERATIONS
Recovery and purification of products, Use of filtration and centrifugation, cell disruption, chemical methods, extraction, chromatographs methods, drying and crystallization, membrane process. Effluent treatment: Disposal methods, treatment process, aerobic and anaerobic treatment, byproducts. Economic aspects: Fermentation as a unit process, economy of fermentation, market potential. Legalization of products like antibiotics and recombinants. 08 Hours

TEXT BOOKS, REFERENCE BOOKS
Refer Syllabus Book

PROTEIN ENGINEERING AND INSILICO DRUG DESIGN
Sub. Code : 10BT-833

I.A Marks : 25
Hours/week : 04 Exam Hrs. : 03
Total Hours : 52 Exam Marks : 100

PART A

UNIT 1:
STRUCTURE OF PROTEINS
Overview of protein structure, PDB, structure based classification, databases, visualization tools, structure alignment, domain architecture databases, protein-ligand interactions. 04 Hours

UNIT 2:
PROTEIN STRUCTURE PREDICTION
Primary structure and its determination, secondary structure prediction and determination of motifs, profiles, patterns, fingerprints, super secondary structures, protein folding pathways, tertiary structure, quaternary structure, methods to determine tertiary and quaternary structure, post translational modification. 06 Hours

UNIT 3:
PROTEIN ENGINEERING AND DESIGN
Methods of protein isolation, purification and quantification; large scale synthesis of engineered proteins, design and synthesis of peptides; methods of detection and analysis of proteins. Protein database analysis, methods to alter primary structure of proteins, examples of engineered proteins, protein design, principles and examples. 06 Hours

UNIT 4:
MOLECULAR MODELING
Constructing an Initial Model, Refining the Model, Manipulating the Model, Visualization. Structure Generation or Retrieval, Structure Visualization, Conformation Generation, Deriving Bioactive Conformations, Molecule Superposition and Alignment, Deriving the Pharmacophoric Pattern, Receptor Mapping, Estimating Biological Activities, Molecular Interactions: Docking, Calculation of Molecular Properties, Energy Calculations (no derivation), Examples of Small Molecular Modeling Work, Nicotinic Ligands, Sigma Ligands, Antimalarial Agents. 10 Hours

PART B

UNIT 5:
INSILICO DRUG DESIGN
Generation of Rational Approaches in Drug Design, Molecular Modeling: The Second Generation, Conceptual Frame and Methodology of Molecular Modeling, The Field Currently Covered, Importance of the “Bioactive Conformation”, Molecular Mimicry and Structural Similarities, Molecular Mimicry, Structural Similarities and Superimposition Techniques, Rational Drug Design and Chemical Intuition, An Important Key and the Role of the Molecular Model, Limitations of Chemical Intuition Major Milestones and Future Perspectives. 06 Hours

UNIT 6:
COMPUTER ASSISTED NEW LEAD DESIGN
Introduction, Basic Concepts, Molecular Recognition by Receptor and Ligand Design, Active Conformation, Approaches to Discover New Functions, Approaches to the Cases with known and unknown receptor structure. 04 Hours

UNIT 7:
DOCKING METHODS
Program GREEN Grid: Three – Dimensional Description of Binding Site Environment and Energy Calculation, Automatic Docking Method, Three-Dimensional Database Search
Approaches, Automated Structure Construction Methods, Structure Construction Methods with known Three-Dimensional Structure of the Receptor, Structure Construction in the case of Unknown Receptor Structure. Points for Consideration in Structure Construction Methods, Handling of X-Ray Structures of Proteins, Future Perspectives. Other web based programs available for molecular modeling, molecular docking and energy minimization techniques – Scope and limitations, interpretation of results. 08 Hours

UNIT 8:
COMPUTER – ASSISTED DRUG DISCOVERY
The Drug Development Process, Introduction, The Discovery and Development Process, New Lead Discovery Strategies, Composition of Drug Discovery Teams, The Practice of Computer- Assisted Drug Discovery (CADD), Current Practice of CADD in the pharmaceutical Industry, Management Structures of CADD Groups, Contributions and Achievements of CADD Groups, Limitations of CADD Support, Inherent Limitations of CADD Support, State of Current Computational Models, Software and Hardware Constraints. 08 Hours

TEXT/REFERENCE BOOKS
Refer Syllabus Book

BIOMEDICAL INSTRUMENTATION
Sub. Code : 10BT-834

I.A Marks : 25
Hours/week : 04 Exam Hrs. : 03
Total Hours : 52 Exam Marks : 100

UNIT 1:
INTRODUCTION
Sources of Biomedical signals, Basic medical instrumentation system, Performance requirements of medical instrumentation systems, PC based medical instruments, General constraints in design of medical instrumentation systems. 04 Hours

UNIT 2:
BIOELECTRIC SIGNALS AND ELECTRODE
Origin of bioelectric signals, Recording electrodes, – Electrode-tissue interface, metal electrolyte interface, electrolyte – skin interface, Polarization, Skin contact impedance, Silver – silver chloride electrodes, Electrodes for ECG, EEG, EMG, Electrical conductivity of electrode jellies and creams, Microelectrode. Patient Safety: Electrode shock hazards, Leakage currents. 08 Hours

UNIT 3:
ECG & EEG
Electrical activity of heart, Genesis & characteristics of Electrocardiogram (ECG), Block diagram description of an Electrocardiograph, ECG Lead Systems, Multichannel ECG machine Genesis of Electroencephalogram (EEG), Block diagram description of an Electroencephalograph, 10-20 Electrode system, Computerized analysis of EEG. 08 Hours

UNIT 4:
CARDIAC PACEMAKERS AND DEFIBRILLATORS
Need for Cardiac pacemaker, External pacemaker, Implantable pacemaker, Programmable pacemakers, DC defibrillator, AC defibrillator and Implantable Defibrillator. 06 Hours

PART B

UNIT 5:
PATIENT MONITORING SYSTEM
Bedside monitors, Central Monitoring System, Measurement of Heart rate – Average heart rate meter, Instantaneous heart rate meter, (Cardio tachometer), Measurement of Pulse Rate, Blood pressure measurement – direct and indirect method, Rheographic method, Oscillometric method, Ultrasonic Doppler shift method, Measurements of Respiration rate – Thermistor method, impedance puenmography, CO2 method, and Apnea detector. Blood flow meters: Electromagnetic and its types, Ultrasonic, NMR, Laser Doppler. Blood gas analyzers: Blood pH measurement, Measurement of Blood pCO2, pO2. 10 Hours

UNIT 6:
PHYSIOLOGICAL TRANSDUCERS
Introduction, classification, performance characteristics of transducers-static and dynamic transducers, Displacement, position and motion transducers, Pressure transducer, Transducers for body temperature measurement, Optical Fiber sensor and Biosensor 04 Hours

UNIT 7:
RECORDING SYSTEMS
Basic recoding system, general considerations for signal conditioners, preamplifiersinstrumentation amplifier, isolation amplifier, ink jet recorder, potentiometric recorder, thermal
array recorder and electrostatic recorder. 04 Hours

UNIT 8:
ANALYSIS
a) Cardiac output measurement: Indicator dilution method, Dye dilution method, Thermal dilution techniques, Measurement of Continuous cardiac output derived from the aortic pressure waveform, Impedance technique. 04 Hours
b) Pulmonary function analysis: Pulmonary function measurement, Spirometry, Puemotachometer, Measurement of Volume, Nitrogen washout technique. 04 Hours

TEXTBOOKS

  • Transducers and instrumentation by D.V.S. Murthy, Prentice Hall of Inida.
  • Principles of Applied Biomedical Instrumentation by Geddes & Baker.
  • Hand book of Biomedical Instrumentation – R. S. Khandpur, 2nd Edition, Tata McGraw-Hill Publishing Company Limited.

REFERENCE BOOKS
Refer Syllabus Book

BIOMOLECULAR ENGINEERING
Sub. Code : 10BT-835

I.A Marks : 25
Hours/week : 04 Exam Hrs. : 03
Total Hours : 52 Exam Marks : 100

PART A

UNIT 1:
THERMODYNAMICS
Volumetric and thermodynamic properties of fluids; equations of state; heat effects; ideal and non-ideal mixtures; fugacities and activity coefficients; vapour-liquid and liquid-liquid phase equilibrium; solubility of gases and solids in liquids; chemical reaction equilibrium. 06 Hours

UNIT 2:
BIOMOLECULAR INTERACTIONS
Thermodynamics of biomolecular interactions, noncovalent forces underlying bioenergetics: hydrogen bonding, van der Waals, hydrophobic effect, water in context of molecular recognition biomolecular stability. Case studies: Stability and energetics of Antibody-Antigen; Streptavidin- Biotin. 06 Hours

UNIT 3:
ENZYME KINETICS
Enzymes as Biological Catalysts, Enzyme Activation, Unireactant Enzymes, Multi-site and Allosteric Enzymes, Simple Inhibition, Multiple Inhibition Models, Multi-Reactant Systems, pH and Temperature Effects. Reaction kinetics and enzyme energetics for the case of Catalytic Antibodies. 06 Hours

UNIT 4:
BIOENERGETICS
Energetics of Biological Systems, Molecular Recognition. Concepts of Free Energy, Enthalpy and Entropy in the living cell, Biochemical Reactions, Metabolic Cycles, ATP Synthesis (Respiration and Photosynthesis), Membrane Ion Gradients (ATP and Ion Gradients), Protein Folding, Protein-Nucleic Acid interactions. Rheology of DNA. Protein misfolding and disease. 08 Hours

PART B

UNIT 5:
BIODESIGN
Rational Biotherapeutic Design: molecular modeling, computational approaches to predicting energetics, Case study: PeptidoMimetic therapeutics. Directed Evolution for Biotherapeutic Design: random mutagenesis approaches and techniques, phage display and selection techniques, combinatorial approaches and techniques. Case study: Antibody Engineering, enzyme engineering, phage display. 08 Hours

UNIT 6:
CELULAR WARFARE
Receptor-mediated recognition in immune system surveillance, macrophage-B-Cell collaboration, T-Cell and natural killer cell function, vaccines. Case studies: Engineered T-Cell Therapeutics, Vaccines. 05 Hours

UNIT 7:
BIOREACTION NETWORKS
Control of Metabolic Pathways, Metabolic Engineering (Metabolic Flux Analysis, Metabolic Control Analyisis), Metabolic Simulations, Systems Biology approaches. 05 Hours

UNIT 8:
APPLICATIONS
Biodegradable materials, Polymeric scaffolds for tissue engineering applications. Biopolymers: heparin and heparin-like polysaccharides, proteoglycans, chemically modified
glycosaminoglycans. Design and production of biomaterials as biosensors. Nanoscale biosensors. 08 Hours

TEXT , REFERENCE BOOKS
Refer Syllabus Book

ELECTIVE E
ENVIRONMENTAL BT
Sub. Code : 10BT-841

I.A Marks : 25
Hours/week : 04 Exam Hrs. : 03
Total Hours : 52 Exam Marks : 100

PART A

UNIT 1:
MICROORGANISMS
Overview of microorganisms, Microbial flora of soil, growth, ecological adaptations, interactions among soil microorganisms, biogeochemical role of soil microorganisms. 02 Hours

UNIT 2:
BIOACCUMULATION OF TOXICANTS
Characteristics of Xenobiotics, Relationship of Bioaccumulation with Chemical Structure, Ecophysiology of Bioaccumulation, Process of toxicants uptake, Factors affecting
bioaccumulation, measurement of bioaccumulation. 04 Hours

UNIT 3:
BIOLOGICAL TREATMENT OF WASTE WATER
Waste water characteristics, Waste water treatment, unit operations, design and modeling of activated – sludge process, Microbial Process for wastewater treatment, BOD, COD, Secondary treatment, Microbial removal of phosphorous and Nitrogen, Nutrient removal by Biomass production. Industrial waste treatment opportunities for reverse osmosis and ultra filtrationl. Wastewater treatment of food processing industries like sugar factories, vegetable oil industries, potato processing industries, dairy industries, beverages industries, dairy industry and distilleries. 10 Hours

UNIT 4:
SOLID WASTE MANAGEMENT
Basic aspects, general composition of urban solid wastes, aerobic treatment, anerobic treatment, biogass generation; Solid waste management through Biotechnological processes involving Hazardous wastes, Biomedical wastes, Dairy wastes, Pulp industry wastes, Textile industry wastes, leather industry wastes and pharmaceutical industry wastes, petroleum wastes treatment. 10 Hours

PART B

UNIT 5:
BIOFUELS
Renewable and non-renewable resources. Conventional fuels and their environmental impacts. Animal oils. Modern fuels and their environmental impacts. Biotechnological inputs in producing good quality natural fibres. Plant sources like Jetropha, Pongamia etc. Waste as an energy core, energy recovery systems for urban waste, technology evaluation, concept of gasification of wastes with molten salt to produce low-BTU gas; pipeline gas from solid wastes by syngas recycling process; conversion of feedlot wastes into pipeline gas; fuels and chemicals from crops, production of oil from wood waste, fuels from wood waste, methanol production from organic wastes. 10 Hours

UNIT 6:
BIOLEACHING & BIOMINING
Microbes in Bioleaching, Metal Recovery, Microbial recovery of phosphate, microbial extraction of petroleum, microbial production of fuels. 04 Hours

UNIT 7:
BIOFERTILIZERS
Biofertilizers Nitrogen fixing microorganisms enrich the soil with assimilable nitrogen. Major contaminants of air, water and soil, Biomonitors of environment (Bioindicators), Bioremediation using microbes, Phytoremediation, Treatment of distillery effluents, Biofilms. 06 Hours

UNIT 8:
BIOTECHNOLOGY IN BIOIVERSITY CONSERVATION
Value of biodiversity, threats to biodiversity, Biosphere reserves and Ecosystem Conservation, Approaches to Bioresource conservation programme, Biotechnological processes for bioresource assessment, BT in ex situ conservation of Biodiversity, BT and its role in utilization of Biodiversity, International initiatives for biodiversity management. 06 Hours

TEXT BOOKS
Environmental Biotechnology by Foster C.F., John ware D.A., Ellis Horwood Limited.
ENVIRONMENTAL BIOTECHNOLOGY by INDU SHEKHAR THAKUR, IK Publishers.
Industrial Microbiology by L.E. Casida, Willey Eastern Ltd.
Industrial Microbiology by Prescott & Dunn, CBS Publishers.

REFERENCE BOOKS
Refer Syllabus Book

METABOLIC ENGINEERING
Sub. Code : 10BT-842

I.A Marks : 25
Hours/week : 04 Exam Hrs. : 03
Total Hours : 52 Exam Marks : 100

PART A

UNIT 1:
INTRODUCTION
Basic concept of metabolic engineering overview of metabolism. Different models for cellular reactions, Mutation, mutagens mutation in metabolic studies. 04 Hours

UNIT 2:
METABOLIC REGULATION
An overview of Cellular Metabolism, Transport Processes, Passive Transport, Facilitated Diffusion, Active Transport, Fueling Reactions, Glycolysis, Fermentative Pathways, TCA Cycle and Oxidative Phosphorylation, Anaplerotic Pathways, Catabolism of Fats, Organic Acids, and Amino Acids, Biosynthetic Reaction, Biosynthesis of Amino Acids, Biosynthesis of Nucleic Acids, Fatty Acids, and Other Building Blocks, Polymerization, Growth Energetics. 10 Hours

UNIT 3:
METABOLIC FLUX
Metabolic flux analysis and its application, Methods for experimental determination of metabolic flux by isotope dilution method. 04 Hours

UNIT 4:
APPLICATIONS OF METABOLIC FLUX ANALYSIS
Amino Acid Production by Glutamic Acid Bacteria, Biochemistry and Regulation of Glutamic Acid Bacteria, Calculation of Theoretical Yields, Metabolic Flux Analysis of Lysine Biosynthetic Network in C. glutamicum, Metabolic Flux Analysis of Specific Deletion Mutants of C. glutamicum, Metabolic Fluxes in Mammalian Cell Cultures, Determination of Intracellular Fluxes, Validation of Flux Estimates by 13 C Labeling Studies, Application of Flux Analysis to the Design of Cell Culture Media. 08 Hours

PART B

UNIT 5:
REGULATION OF METABOLIC PATHWAYS
Regulation of Enzymatic Activity, Overview of Enzyme Kinetics, Simple Reversible Inhibition Systems, Irreversible Inhibition, Allosteric Enzymes: Cooperativity, Regulation of Enzyme Concentration, Control of Transcription Initiation, Control of Translation, Global Control: Regulation at the Whole Cell Level, Regulation of Metabolic Networks, Branch Point Classification, Coupled Reactions and the Role of Global Currency Metabolites. 06 Hours

UNIT 6:
METABOLIC ENGINEERING IN PRACTICE
Enhancement of Product Yield and Productivity, Ethanol, Amino Acids, Solvents, Extension of Substrate Range, Metabolic Engineering of Pentose Metabolism for Ethanol Production, Cellulose-Hemicellulose Depolymerization, Lactose and Whey Utilization, Sucrose Utilization, Starch Degrading Microorganisms, Extension of Product Spectrum and Novel Products, Antibiotics, Polyketides, Vitamins, Biopolymers, Biological Pigments, Hydrogen, Pentoses: Xylitol, Improvement of Cellular Properties, Alteration of Nitrogen Metabolism, Enhanced Oxygen Utilization, Prevention of Overflow Metabolism, Alteration of Substrate Uptake, Maintenance of Genetic Stability, Xenobiotic Degradation, Polychlorinated Biphenyls (PCBs), Benzene, Toluene, P-Xylene Mixtures (BTX). 10 Hours

UNIT 7:
BIOSYNTHESIS OF METABOLITES
Primary metabolites: Alteration of feed back regulation, limiting of accumulation of end products, resistant mutants. Secondary metabolites: Precursor effects, prophage, idiophase relationship, enzyme induction, feedback repression, catabolic repression, Important groups of secondary metabolic enzymes, phosphotransferase, ligases oxido reductases, oxygenases, carboxylases. 06 Hours

UNIT 8:
BIOCONVERSIONS
Advantages of bioconverstions, specificity, yields. Factors important to bioconversions regulation of enzyme synthesis, permeability co metabolism, convertion of insoluble substrates. 04 Hours

TEXT BOOKS , REFERENCE BOOKS
Refer Syllabus Book

MEDICAL INFORMATICS
Sub. Code : 10BT-843

I.A Marks : 25
Hours/week : 04 Exam Hrs. : 03
Total Hours : 52 Exam Marks : 100

PART A

UNIT 1:
INTRODUCTION
Aim and scope, historical perspectives, concepts and activities in medical informatics, definition of medical informatics, online learning, introduction to the application of information technology to integrated hospital information systems and patient-specific information; nursing, radiology, pathology, and pharmacy services, Future trends, research in medical informatics, training and opportunities in medical informatics. 07 Hours

UNIT 2:
HOSPITAL MANAGEMENT AND INFORMATION SYSTEMS
Hospital Management and Information Systems (HMIS), its need, benefits, capabilities, development, functional areas. Modules forming HMIS, HMIS and Internet, Pre-requisites for HMIS, why HMIS fails, health information system, disaster management plans, advantages of HMIS. Study of picture archival & communication systems (PACS), PACS Administrator, PACS Technology overview, PACS Administration: The Business Perspective. 06 Hours

UNIT 3:
PATIENT DATA MODULES
Structuring medical records to carry out functions like admissions, discharges, treatment history etc. Central Registration Module, OPD / Consultant Clinic / Polyclinic Module, Indoor Ward Module, Patient Care Module, Procedure Module, Diet Planning Module, MLC Register Module. Medical Examination, Account Billing, 07 Hours

UNIT 4:
ELECTRONIC HEALTH RECORDS
Pathology Laboratory Module, Blood Bank Module, Operation Theatre Module, Medical Stores Module, Pharmacy Module, Inventory Module, Radiology Module, Medical Records Index Module, Administration Module, Personal Registration Module, Employee Information Module, Financial modules, Health & Family Welfare, Medical Research, Communication, General Information. 06 Hours

PART B

UNIT 5:
KNOWLEDGE BASED EXPERT SYSTEMS
AI, expert systems, materials and methods, applications of ES, Introduction to computer based patient record, development tools, intranet, CPR in radiology, legal security and private issues, application service providers. Critical medical issues: security, confidentiality, privacy, accuracy and access. 06 Hours

UNIT 6:
COMPUTER ASSISTED MEDICAL EDUCATION
Computer Assisted Medical Education & Surgery (CAME), Education software, Tele-education, Tele-mentoring, CAPE, patient counselling software. Limitation of conventional surgery, computer assisted surgery (CAS), 3D navigation system, intra-operative imaging for 3D navigation system, merits and demerits of CAS. Computer support collaborative learning, Future of Computer Aidede Learning (CAL). 07 Hours

UNIT 7:
SURGICAL SIMULATION AND VIRTUAL ENVIRONMENT
Need, technology, volume image data file, human resources, interface and applications. Virtual environment (VE), technology, applications of VE, advantages of simulators and after effects of VE participation. Millirobotics for remote surgery, Telesurgery, and endoscopy 05 Hours

UNIT 8:
TELEMEDICINE
History and advances in telemedicine, Benefits of telemedicine, Communication infrastructure for telemedicine – LAN and WAN technology. Satellite communication. Mobile hand held  devices, Internet technology and telemedicine using world wide web (www). Video and audio conferencing. Medical information storage and management for telemedicine- patient information medical history, test reports, medical images diagnosis and treatment. Hospital information-Doctors, paramedics, facilities available. Pharmaceutical information, Security and confidentially of medical records and access control, Cyber laws related to telemedicine, Telemedicine access to health care services, health education and self care. 08 Hours

TEXT BOOKS
Medical Informatics, a Primer by Mohan Bansal, TMH publications.
Medical Informatics: Computer applications in health care and biomedicine by E.H.Shortliffe, G.
Wiederhold, L.E.Perreault and L.M.Fagan, Springer Verlag.
Handbook of Medical Informatics by J.H.Van Bemmel, Stanford University Press.
Biomedical Information Technology by David D Feng, Elsevier.
Emerging Trends in Biomedical Science and Health by D V Rai, IK Intl. Ltd.

TISSUE ENGINEERING
Sub. Code : 10BT-844

I.A Marks : 25
Hours/week : 04 Exam Hrs. : 03
Total Hours : 52 Exam Marks : 100

PART A

UNIT 1:
CELL AND TISSUE BIOLOGY
Introduction to cell – biology and biochemistry. Tissue development and organization. Stem cells (embryonic), Stem cells (adult). Introduction to cell adhesion, Adhesion Receptors in Tissue Structures, Cell Adhesion to Biomaterials, Measurement of Cell Adhesion, Effect of Biomaterial on Physiological Behavior. Introduction to cell migration, Characteristics of Mammalian Cell Migration, Regulation of Cell Movement, Cell Migration Assays, Mathematical Models for Cell Migration and Tissue Growth. 08 Hours

UNIT 2:
EXTRACELLULAR MATRIX
Introduction, ECM and Functional Integration of Implanted Materials, Basement Membranes and Focal Adhesions, Focal Adhesions as Signaling Complexes, ECM and Skeletal Tissues, Sources of ECM for Tissue Engineering Applications, Properties of ECM , Mining the ECM for Functional Motifs, Summary of Functions of ECM Molecules, Polymeric Materials and their Surface Modification, Formation of Gradient Structures, Delivery of Growth Factors. 08 Hours

UNIT 3:
BIOMATERIALS
Introduction to synthetic polymers, Biodegradable materials v/s permanent materials, Natural biopolymers and hydrogels, Mechanical properties of biomaterials, Surface modification and characterization of polymers, Immune response to biomaterials, In vitro assessment/biocompatibility/protein adsorption. Polymeric scaffolds for tissue engineering applications. 06 Hours

UNIT 4:
DRUG AND GROWTH FACTOR DELIVERY
Drug delivery, Mechanisms of Drug Delivery, Protein-Drug Properties, Drug Delivery in Tissue Engineering, Introduction to growth factors, Polymer scaffold delivery systems, Polymer hydrogel delivery systems, Polymer microsphere technology. 04 Hours

PART B

UNIT 5:
TISSUE ENGINEERING BIOREACTORS
Introduction, Most common Bioreactors in Tissue Engineering, Cell Seeding in Bioreactors, Bioreactor Applications in Functional Tissues, Design Considerations, Challenges in Bioreactor Technologies. 08 Hours

UNIT 6:
SCAFFOLD DESIGN AND FABRICATION
Tissue Biomechanics, Scaffold design and fabrication, Natural Polymers for Scaffold Fabrication, Synthetic Polymers for Scaffold Fabrication, Scaffold Design Properties.
06 Hours

UNIT 7:
CLINICAL IMPLEMENTATION
Tissue Engineering of Skin, Bone Tissue Engineering, Cartilage Tissue Engineering, Neuronal Tissue Engineering, Cardiovascular Tissue Engineering, Musculoskeletal Tissue Engineering (tendon/ligament/muscle), Adipose Tissue Engineering. 06 Hours

UNIT 8:
THE REGULATION OF ENGINEERED TISSUES
Introduction, FDA Regulation, Regulation of Pharmaceutical / Medical Human Tissue Products in Europe, Regulation of Pharmaceutical / Medical Human Tissue Products in Japan, Other considerations Relevant to Engineered Tissues. 06 Hours

REFERENCE/TEXT BOOKS
Refer Syllabus Book

FACILITATION, VALIDATION & QC
Sub. Code : 10BT-845

I.A Marks : 25
Hours/week : 04 Exam Hrs. : 03
Total Hours : 52 Exam Marks : 100

PART A

UNIT 1:
INTRODUCTION
Validation and Regulatory Affairs in Bio (Pharmaceutical) Manufacturing: An Introduction to FDA Operations & Industry Compliance Regulations, The Fundamentals of Regulatory Compliance with respect to Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) & Good Laboratory Practice (GLP). An Introduction to the Basic Concepts of Process Validation & how it Differs from Qualification (IQ, OQ & PQ) Procedures, A Review of Prospective, Concurrent, Retrospective Validation & Revalidation including the use of Statistical Process Control (SPC) Techniques. 08 Hours

UNIT 2:
PLANNING
ISO 9000 Series & International Harmonization & their effect upon GMP’s, Planning & Managing a Validation Program including Change Control, Scale-Up and Post-Approval
Changes (SUPAC), PAI & Technology Transfer Issues. 04 Hours

UNIT 3:
VALIDATION
Validation of Water & Thermal Systems, including HVAC Facilities & Cleaning Validation. Validation of Active Pharmaceutical Ingredients (APIs) & Aseptic Processes. Validation of Non- Sterile Processes (used in the manufacture of Solids, Liquids, & Semisolid Dosage Forms). Overview of method evolution, FDA and ICH guidelines, Development and validation, Basic statistical concepts, Outliers, Specificity: sample preparation, Specificity: separations, Specificity: detectors, Linearity, Accuracy, Precision, Limits of detection (LOD) and quantification (LOQ), Minimum detectable amount (MDA), Sample stability and method robustness, Window diagrams, System suitability, Statistical process control for HPLC, Sustainable validation, Troubleshooting out-of-control systems, Case studies. 08 Hours

UNIT 4:
GAMP
Medical Device, In-Vitro Diagnostics & Packaging Validation Issues, Validation of Analytical Methods, Computerized & Automated Systems under 21 CFR Part 11 & the Influence of Good Automated Manufacturing Practice (GAMP); The FDA’s Approach to GMP Inspections of Pharmaceutical Companies. 06 Hours

PART B

UNIT 5:
STANDARDS
Introduction, ISO 9000 Series of Standards, Management Responsibility, Quality System, Contract Review, Design Control, Document and Data Control, Preservation and Delivery, Control of Quality Records, Internal Quality Audits, Training, Servicing, Statistical Techniques, ISO-9001-2000, Scope, Normative Reference, Terms and Definitions, Quality Management, System, Documents Requirements, Management’s Responsibility, Resource Management, Infrastructure, Product Realization, Measurement, Analysis and Improvement, ISO-14001 – Environmental Management Systems. 05 Hours

UNIT 5:
IMPLEMENATION
Quality System, Contract Review, Design Control, Document and Data Control, Purchasing, Control of Customer Supplied Product, Product Identification and Traceability, Process Control, Inspection and Testing, Final Inspection and Testing, Control of Inspection, Measuring and Test Equipment, Inspection and Test Status, Control of Nonconforming Product, Corrective and Preventive Action, Handling, Storage, Packaging, Preservation and Delivery, Control of Quality Records, Internal Quality Audits, Training, Servicing, Statistical Techniques. 05 Hours

UNIT 7:
QUALITY
Terminology Relating to Quality, Quality Requirement, Customer Satisfaction, Capability; Terms Relating to Management, Management System, Quality Management System, Quality Policy, Quality Objectives, Quality Planning, Quality Control, Quality Assurance, Quality Improvement, Continual Improvement, Effectiveness, Efficiency; Relating to Process and Product, Process, Product, Procedure; Terms relating to Characteristics, Quality Characteristics; Terms Relating to Conformity, Non-Conformity, Defect, Preventive Action, Corrective Action, Correction, Rework, Repair, Scrap, Concession, Deviation Permit, Release; Terms Relating to Documentation, Information, Document, Specification, Quality Manual, Quality Plan, Record; Terms Relating of Examination, Objective Evidence, Inspection, Test, Metrological Confirmation. 08 Hours

UNIT 8:
QUALITY MANAGEMENT
The development of regulatory requirements for validation, The V model and Life Cycle model approach to validation and documentation, Risk Analysis Techniques: Impact Assessment; Failure Mode and Effects Analysis (FMEA), Validation Master Plans, Commissioning and Qualification, Process Validation, Routine validation and revalidation, Contamination Control, Risk Management in the Pharmaceutical Industry, Solid Dose Manufacture Principles and Practices, Liquid and Cream Manufacture Principles and Practices, Good Laboratory Practices (for Non-Clinical Laboratories), Computer Systems Validation Principles and Practices, Good Aseptic Practices and Sterile Products, Clinical Trials Quality Assurance Management, GxP and Quality Auditing Practices, Pharmaceutical Engineering – Facility, Equipment and Process Design, Fundamentals of Process Analytical Technology, Quality and Continuous Improvement in the Pharmaceutical Industry. 08 Hours

TEXT/REFERENCE BOOKS
Refer Syllabus Book

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