Biotechnology in Pharmaceutical Sciences

Teacher

Shruti Rajwar

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Course Name : Biotechnology in Pharmaceutical Sciences

Code (Credit) : CUTM 1645 (4+2+0)

Course Objectives

The course will cover in depth knowledge of Forensic Biotechnology in Pharmaceutical Science, it's disciplines and their importance when working in FSL.

Learning Outcomes

  • The significance of forensic biotechnology in pharmaceutical sciences
  • The fundamental principles, functions and application of industrial products in forensic science
  • The uses of industrial microbiology in forensic science laboratory
  • The working of the regulatory affairs in forensic establishments in India

Course Syllabus

Unit-I

Introduction to Recombinant DNA Technology

DNA Modifying enzymes. Cloning strategies: Genomic libraries, cDNA libraries, single gene cloning. RAPD, RFLP and AFLP. Vectors: Types of vectors and choice of vectors : Plasmids, Cosmids, lambda phage, shuttle vectors, bacs and yacs. Transformation and Transfection. Expression system in Eukaryotic cells, Yeast, Bacteria, Insect cell lines, Gene screening. Biosafety guidelines and containment startegies

Unit-II (Bioprocess and Bio-chemical engineering)

Bioreactor design: Body construction, aeration and agitation, operation and applications. Microbial growth: measurement, batch and continuous culture and its kinetics. Downstream processing: recovery and purification of products. Strain improvement. Fermentation economics

Unit-III (Animal and Plant Biotechnology)

Cell lines: definition, development, maintenance and management , established cell lines and their characteristic features. Transgenic animals : creating transgenic animals, examples of transgenic animals - Dolly, insects, primates, mice. Somaclonal and gameto clonal variation: applications and limitations. Transgenic Plants: Herbicide resistant, insect Resistant, drought/stress resistant, delayed ripening, Ti Plasmid and T-DNA transfer. Gene therapy: potential approach to gene therapy. Southern blotting, Northern blotting, Western blotting, Iso-electric focusing. Overview of Stem cells and its applications

Unit-IV (Biotherapeutics and Industrial Microbiology)

Introduction to industry important recombinant proteins, recombinant protein stability. Improvised recombinant protein secretion. Introduction to industrially important primary and secondary metabolites from plants and microbes. Microbial production: Antibiotics, acetic acid, lactic acid, wine, beer, SCP

Unit-V (Regulatory affairs and IPR)

Basic principles of quality control (QC) and quality assurance (QA). Guidelines for QA and QC: raw materials, products and validation. Introduction to pharmacopoeia. Intellectual Property Rights. Importance of protecting scientific discoveries. IPR policy of Government of India. Patent: Qualification (novel, commercial and non-obvious), jurisdiction of patent laws, Indian and international patent laws, filing procedures.

Reference Books

  • Pharmaceutical Biotechnology : Concepts & Applications – Gary Walsh (Wiley)
  • Modern Industrial Microbiology and Biotechnology – Nduka Okafor (Sciences Publisher)
  • Biotechnology and Biopharmaceuticals – Rodney J.Y.H.O and Milo Gibaldi (Wiley)
  • Biotechnology in Healthcare – Gavin Brooks (PLP)
  • Gene Therapy: Protocols - Joseph M. Le Doux (Humana Press)
  • Biotehnology – Applying the genetic revolution – David P. Clark and Nanette J. Pazdarnik, Academic Press, ISBN: 978-0121755522
  • Molecular Biotechnology: Principles and Applications of Recombinant DNA, 4th Edition –

 

Bernard G. Glick, Jack J. Pasternak and Cheryl L. Patten, ASM Press, ISBN: 978-1555814984

Session Plan

Session-1

DNA Modifying enzymes mod2 DNADNA Modifying Enzymes

Session-2

Cloning strategies: Genomic Libraries04_M109nys091016_19_23

Session-3

cDNA libraries, single gene cloning Send Genomic and cDNA libraries04_M109nys091016_19_23

Session-5

Vectors: Types of vectorsMSc-Biotech-02Sem-ProfBhuminathTripathi

Session-6

Choice of vectors: Plasmids, Cosmid, Lambda Phage vectors119_Cloning vectors

Session-7

Shuttle vectors, BACS, YACSSend Cloning Vectors-1

Session-8

Transformation and Transfection transfection-slideshowpeerj-111653 Transformation

Session-9

Expression system in Eukaryotic cells, Yeast, Bacteriaexpression_systems

Session-10

Insect cell lines, Gene screeningexpression_systemsIntroduction_to_Genetic_Screening

Session-11

Biosafety guidelines and containment strategies

Session-12

Bioreactor body construction. Aeration, agitation. Operation and Principals30042020085526-BIOREACTOR__BASICS-converted_(1)

Session-14

Batch and continuous culture and its kinetics

https://www.youtube.com/watch?v=mUDXupn2Dhk

1816_microbialculture

Session-15

Downstream processing: Recovery and purification of productsSend Downstream Processing-1

Session-16

Strain ImprovementSend Strain Improvement

Session-17

Fermentation Economics

Session-18

Cell lines: Definition, development, maintenance and management, established cell lines and their characteristic features.

 

Session-19

Transgenic animals- Creating transgenic animals, Example of transgenic animals-DollySend Transgenic Animals

Session-20

Insects, Primates, miceSend Transgenic Animals

Session-21

Somaclonal and gameto clonal variationSend UDAY.SOMACLONAL.

Session-22

applications and limitations

Session-23

Transgenic Plants: Herbicide resistant, insect ResistantSend Transgenic Plants

Session-24

drought/stress resistant, delayed ripeningSend ayaskanta ppt

Session-25

Ti Plasmid and T-DNA transfer.

Session-26

Gene therapy: potential approach to gene therapyGene Therapy-1

Session-27

Southern blotting, Northern blottingSend blotting

Session-28

Western blotting,  Iso-electric focusingSend blotting

Session-29

Overview of Stem cells and its applicationsstem cells

Session-30

Introduction to industry important recombinant proteins, recombinant protein stabilitymicrobial recombinant protein

Session-31

Improvised recombinant protein secretion

Session-32

Introduction to industrially important primary and secondary metabolites from plants and microbes

Session-33

Microbial production: Antibiotics, acetic acid, lactic acid Production of Lactic AcidProduction of Acetic Acid

Session-35

Basic principles of quality control (QC) and quality assurance (QA)_QA-QC

Session-36

Guidelines for QA and QC: raw materials, products and validation

Session-37

Introduction to pharmacopoeia000214416

Session-38

Intellectual Property RightsINTELLECTUAL-PROPERTY-RIGHTS_20.04.2020

Session-39

Importance of protecting scientific discoveries

IPR policy of Government of IndiaIntellectual Property Right (IPR) and Protection(IPP

Session-40

Patent: Qualification (novel, commercial and non-obvious), jurisdiction of patent laws, Indian and international patent laws, filing procedures.IPR

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Shruti Rajwar

Assistant Professor
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