VTU M. Tech Bio Technology 4th Semester Syllabus

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METABOLIC ENGINEERING
Subject Code : 14BBT422

IA Marks : 50
No. of Lecture Hrs./ Week : 04 Exam Hrs : 03
Total No. of Lecture Hrs. : 50 Exam Marks : 100

COURSE OBJECTIVES:
Explore the importance of metabolic engineering in relation to cellular reaction
Analyse the strategy for product enhancement and yield along with metabolic flux.

MODULE 1: 10 Hours
Introduction to Cellular Metabolism: Metabolic engineering and its multidisciplinary nature; Review of cellular metabolism; Models for cellular reactions; Material balances and data consistency-Block box model, elemental balances, heat balance and analysis.

MODULE 2: 10 Hours
Regulation of Metabolic Pathways: Regulation of enzyme activity- Reversible and irreversible inhibition systems, regulation of enzyme concentration- Control of transcription and translation. Global control: Regulation at whole cell level- regulation of metabolic networks.

MODULE 3: 10 Hours
Metabolic Pathway Manipulations: Enhancement of product yield and productivity- Ethanol, Amino acids and Solvents. Extension of substrate- Sucrose utilization and pentose metabolism for ethanol production. Product spectrum and novel products- Antibiotics, Polyketides, Vitamins, Biological pigments. Improvements of cellular properties-Nitrogen metabolism, Oxygen utilization, Overflow metabolism and genetic stability maintenance. Xenobiotics degradation of Polychlorinated Biphenyls (PCBs) and Benzene, Toluene,
p-Xylene Mixtures (BTX).

MODULE 4: 10 Hours
Metabolic Flux Analysis: Methods for determination of metabolic fluxes by isotope labeling- Fractional label enrichment, complete enumeration of TCA cycle metabolite isotopomers from labeled pyruvate and acetate. Applications of metabolic flux analysis: Amino acid production by Glutamic acid bacteria and mammalian cell cultures. Flux analysis of metabolic networks- Bottom-up Approach, Top-Down Approach.

MODULE 5: 10 Hours
Metabolic Control Analysis (MCA): MCA theorems, determination of flux control coefficient. MCA of linear and branched pathways. Theory of large deviations

COURSE OUTCOMES:
After completion of the course, students are able to utilize the knowledge of cellular metabolic pathway and regulation to enhance the yield.

TEXT BOOKS:
1. Gregory N. Stephanopoulos, Aristos A. Aristidou and Jens Nielsen. Metabolic engineering – Principles and Methodologies. Academic press, USA 1998.
2. Nestor V. Torres and Eberhard O. Voit, Pathway analysis and optimization in metabolic, Cambridge University Press, 2002.

REFERENCE BOOKS:
3. Shuler M.L. and F. Kargi. Bioprocess engineering basic concepts, 2nd Edn, Prentice Hall, 2001.
4. Cortassa s., Aon, M.A., Lglesias, A.A., and L LyodD. An introduction and metabolic and cellular Engineering. World scientific publications Pvt ltd. Singapore. 2002.

CLINICAL BIOTECHNOLOGY
Subject Code : 14BBT421

IA Marks : 50
No. of Lecture Hrs./ Week : 04 Exam Hrs : 03
Total No. of Lecture Hrs. : 50 Exam Marks : 100

COURSE OBJECTIVES:
To understand and emphasis on the various domain of clinical trials and drug metabolism
To evaluate the intensity and integrity of various diseases and implications of various governing agencies

MODULE 1: 10 Hours
Introduction: Introduction to Clinical study and design of clinical studies. Epidemiological research and treatment studies: Doubleblind and Single-blind Randomized controlled trial, Non-blind trial, Nonrandomized trial-quasi-experiment. Observational studies: Cohort study- Prospective cohort and Retrospective cohort. Time series study, Case-control study and Nested case-control study. Community survey and Ecological study. Seasonal studies: Conduction of studies in seasonal indications such as Allergies
and Influenza.

MODULE 2: 10 Hours
Statistical Analysis and Interpretation: Background and purpose, trial design consideration, Parallel group design, cross over design, factorial design. Introduction to Statistical Application Software (SAS), procedures and clinical data management.

MODULE 3: 10 Hours
Drug Design and Synthesis: Synthesis of compounds in accordance with the molecular structure and biological activity concept: Analgesics, neuromuscular blocking agents, anti-fertility drugs and bactericidal & bacteriostatic agents (sulphonamides, mercury compounds and antiseptics).
Study of Therapeutic Proteins and Related Case Studies: Blood and Blood products: Clotting factors, anticoagulants, Thrombolytic Agents, Tissue plasminogen activator and streptokinase. Safety guidelines in Blood Transfusion. Therapeutic Proteins: Antibodies, Enzymes, Hormones, Growth factors (Erythropoietin), Vaccines (HIV and Cancer), Interferon and Interleukins.

MODULE 4: 10 Hours
Cancer Biology and Therapy: Introduction to cancer biology and modes of treatment: radiotherapy, chemotherapy, surgery, Biological therapy, immunotherapy and gene therapy.
Clinical Toxicology: Basic concept in toxicology. Types and mechanism of toxin action- Epoxidation & drug toxicity, N-oxidation & drug toxicity and sulphur xenobiotics. Hepatotoxicity and Nephrotoxicity. Biotransformation of toxins, inactivation and removal from the body.

MODULE 5: 10 Hours
Clinical Research Governance and Ethics: Overview on regulatory affairs for pharmaceuticals, neutraceuticals and medical devices.
Good Clinical Practices (GCP) and International quality standard and related guidelines (ICH-E6). Risk assessment and trial monitoring. Legal and ethical issues on biotechnology, medical research and related clinical practice.

COURSE OUTCOMES:
After completion of the course, students are able to differentiate between drug toxicity and drugconcentration along with the mechanism of various interactions of health sectors.

TEXT BOOKS:
1. Designing clinical research by Stephen B. Hulley 3rd Edition, 2007
2. Principles and practice of clinical research by John I. Gallin, Frederick P. Ognibene 2nd Edition, 2006
3. Conducting GCP- Compliant Clinical Research: A Practical Guide by Wendy Bohaychuk, Graham Ball University Edition John Wiley & Sons Ltd, New York, 2009.

REFERENCE BOOKS:
4. Basic biotechnology by Colin Ratledge, Bjørn Kristiansen 3rd Edition Cambridge University Press, Cambridge, 2001.
5. Pharmaceutical Perspectives of Cancer Therapeutics by Ram I. Mahato, Yi Lu University Edition Springer Dordrecht Heidelberg London, 2001.
6. Design and analysis of clinical trials: concepts and methodologies by Shein-Chung Chow, Jen-pei Liu 2nd Edition John Wiley & Sons Ltd, New York, 2004
7. New drug development: design, methodology, and analysis by J. Rick Turner University Edition John Wiley & Sons Ltd, New York. 2004

RESEARCH METHODOLOGY, BIOSAFETY& IPR
Subject Code : 14BBT41

IA Marks : 50
No. of Lecture Hrs./ Week : 04 Exam Hrs : 03
Total No. of Lecture Hrs. : 50 Exam Marks : 100

COURSE OBJECTIVES:
To understand the concept of research its approach and methodology
To be acquainted with various aspects of Intellectual rights and their usage to modern technology

MODULE 1: 10 Hours
Concept of Research: Types & classification, steps involved. Identification of the research question, hypotheses, and justification for the topic.
Literature Collection: Review of literature, review process and bibliography. Research Objectives and hypothesis.
Research Design: Detailed discussion of the conceptualization and operationalization of variables. Research method and materials,
Research action. Data collection and analysis plan: data gathering – thorough description of methods of data gathering and sources.
Scientific writing: Organization and writing of a research papers, short communications, review articles, technical and survey reports, dissertations and books. Organization of reference material, bibliography, Endnote to be discussed with case studies. Research budget and resources.

MODULE 2: 10 Hours
Introduction to Intellectual Property Rights: Types of IPR: Patents, Trademarks, Copyright & Related Rights, Issues related to plagiarism in research, copyright laws, acknowledging the sources etc to be discussed with case studies. Basics of Patents and Concept of Prior Art; Introduction to Patents; Types of patent applications: Ordinary, PCT, Conventional, Divisional and Patent of Addition; Specifications: Provisional and complete; Forms and fees Invention in context of “prior art”; Patent databases; Searching International Databases; Country-wise patent searches (USPTO, EPO, PATENTScope, WIPO, IPO, etc.).

MODULE 3: 10 Hours
IPR in Research: Traditional Knowledge, Geographical Indications, Protection of GMOs, IP as a factor in R&D; IPs of relevance to Biotechnology and few Case Studies. Patent filing procedures; National & PCT filing procedure; Time frame and cost; Status of the patent applications filed; Precautions while patenting – disclosure/non-disclosure; Financial assistance for patenting – introduction to existing schemes Patent licensing and agreement Patent infringement- meaning, scope, litigation, case studies.

MODULE 4: 10 Hours
Biosafety: Introduction & historical background; Primary Containment for Biohazards; Biosafety Levels for Microbes, Plants & Animals; Biosafety guidelines – Government of India; Definition of GMOs & LMOs: RCGM, GEAC etc. for GMO applications in food and agriculture; Environmental release of GMOs; Risk Analysis; Risk Assessment; Risk management and communication. Roles of Institutional Biosafety Committees.

MODULE 5: 10 Hours
Patent laws: History, broad account & latest amendments (if any) of the provisions of Indian Patent Act 1970 & recent amendments, GATT & TRIPS Agreement, Madrid Agreement, Hague Agreement, WIPO Treaties, Budapest Treaty, PCT.

COURSE OUTCOMES:
After completion of the course, students are able to find appropriate method for research problems and hypothesis it, utilize research assets in principled manner with proper safety measures. They will be able to analyse the patentability of the inventions.

TEXT BOOKS:
1. C R Kothari Research Methodology, New Age International (P) Ltd. 2008
2. Wayne Goddard, Stuart Melville Research Methodology: An Introduction: Juta and Company Ltd, 2004
3. M. K. Sateesh. Bioethics and Biosafety By IK International 2008

REFERENCE BOOKS:
4. D K Bhattacharyya, Research Methodology By Excel Publisher Publishing Co. Pvt. Ltd., 2007
5. Kankanala C., Genetic Patent Law & Strategy 1st Edition, Manupatra Information Solution Pvt. Ltd., 2007
6. P. Hambleton, J. Melling, T. T. Salusbury Biosafety in industrial biotechnology – Springer

PROJECT MANAGEMENT, ENTREPRENEURSHIP AND BIOBUSINESS
Subject Code : 14BBT423

IA Marks : 50
No. of Lecture Hrs./ Week : 04 Exam Hrs : 03
Total No. of Lecture Hrs. : 50 Exam Marks : 100

COURSE OBJECTIVES:
Describe logically various aspects of management, building blocks and their relationship
To encourage investment and innovation for technologies and reward innovativeness

MODULE I: 10 HOURS
Project planning – scope – problem statement – project goals – objectives – success criteria – assumptions – risks – obstacles – approval process – projects and strategic planning. Project implementation – project resource requirements – types of resources – men –materials finance. Case studies.

MODULE II: 10 HOURS
Project monitoring – evaluation – control – project network technique –planning for monitoring and evaluation – project audits – project management information system – project scheduling – PERT & CPM –project communication – post project reviews and Case studies. Project team management – recruitment – organizing – human resources – team operating rules – project organization – various forms of project organizations. Closing the project – types of project termination – strategic implications – project in trouble – termination strategies – evaluation of termination possibilities.

MODULE III 10 HOURS
Fundamentals of Entrepreneurship, Ideas to Reality, Proof of Concepts to Product realization, Strategic Management, Forms of Ownership and Franchising, Buying an existing Business, Business Models, Mobilization of Financial resources; Bank loans & Venture capitalism. Building a good Marketing Plan, Concepts in MSME. Accounting for planning, control, and motivation. Factors influencing capital acquisition and allocation. Financial decision making; Decision making under uncertainty; positive and normative models; Current issues in financial management. Case studies.

MODULE IV: 10 HOURS
Industrial R&D and product development. Product development and project management in Agri, Pharma, Health and other biotech industries. Overview of issues and techniques involved in conducting & outcome of research. The multidisciplinary nature of outcomes research: research design and methods, data collection measurement instruments and clinical endpoints, quality of life issues, behavior change, and cost-effectiveness. Analysis Transition from R&D to business units. Product development, market learning and transition from R&D. Management of radical innovation technologies vs. stage gate approach in product development. Case studies.

MODULE V: 10 HOURS
Rights and responsibilities of business under the Indian Constitutional system. Basic standards, rules, principles and issues relating to the law of corporations; core issues affect the corporate governance of business; relationship between management, boards and shareholders. Business laws applied to Biotech industries.
Regulatory issues in Biotech industries with special reference to clinical trial of pharma products and field trials of Agricultural products. Regulatory processes details. Intellectual property in biotech. Business. Models around intellectual property, licensing issues. Product development for commercial ventures. Bioethics and Current legal issues. Ethics of new technology. Case studies.

COURSE OUTCOMES:
After completion of the course, students are able to understand the entrepreneurship opportunities, and importance of innovation with regard to industrial applications.They would also learn project management in the competitive environment existing globally.

TEXT/REFERENCE BOOKS
1. Beenet P Lientz, Kathyn, Project Management – for 21st Centrury- Academic Press, 1995
2. Martin Grossmann Entrepreneurship in Biotechnology: managing for growth from start-up to initial public offering. Verlag. Springer-2003
3. Holger Patzelt and Thomas Brenner. Handbook of Bioentrepreneurship By Springer 2008
4. Graham Dutfield, IPR, Trade and Biodiversity, Earthscan publications, 2000

TEXT/REFERENCE BOOKS
5. Damian Hine, John Kapeleris. Innovation and entrepreneurship in biotechnology, an international prospective. By Edward Elgar Publishing. 2006
6. P. S. Teng. Bioscience entrepreneurship in Asia: creating value with biology. By World scientific publishing. Co. Pte. Ltd. 2008
7. A.K. Singh. Entrepreneurship Development and Management by Firewall Media, 2006
8. Ramachandran, Entrepreneurship Development by. Tata McGraw-Hill Education, 2008

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