Biotechnology in Pharmaceutical Sciences

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Mr. Vikash Kumar

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Core Courses

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Course Name : Biotechnology in Pharmaceutical Sciences

 

Code(Credit) : MSFS2112(4-0-0)

Course Objectives

This course will cover in depth knowledge of Forensic Biotechnology in Pharmaceutical science, it’s disciplines and importance and working of 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 a 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,lamda phage vectors, shuttle vectors, BACs and YACs. Transformation and Transfection. Expression systems in Eukaryotic cells, Yeast, Bacteria, Insect cell lines, Gene screening. Biosafety guidelines and containment strategies

 

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. Strains improvement. Fermentation economics.

 

UNIT-III (Animal and Plant biotechnology)

Cell lines: Definition, development, maintenance and management, established cell lines andtheir characteristic features. Transgenic animals- Creating transgenic animals, Example of transgenic animals-Dolly, Insects, Primates, mice. Somaclonal and gameto clonal variation: applications and limitations. Transgenic Plants: Herbicide eesistant, 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
  • Plant, Gene and Crop Biotechnology, 2nd Edition – Maarten J. Chrispeels and David E. Sadava, Jones and Bartlett Publishers, ISBN: 978-0763715861
  • Biotechnology – U. Satyanarayana, Books and Allied (P) Ltd., ISBN:
  • Plant Tissue Culture by MK Razdan & SS Bhojwani (1996) Elsevier
  • Freshney, Culture of Animal Cells, 5th Edition, Wiley-Liss, 2005 Ed. John R.W. Masters, Animal Cell Culture - Practical Approach,3rd Edition, Oxford University Press, 2000

Session Plan

Session 1

DNA modifying enzymes

Session 2

Cloning strategies: Genomic libraries

Session 3

cDNA libraries, single gene cloning.

Session 4

RAPD, RFLP and AFLP

Session 5

Vectors: Types of vectors

Session 6

choice of vectors- Plasmids, cosmids

Session 7

lamda phage vectors, shuttle vectors

Session 8

BACs and YACs

Session 9

Transformation and Transfection

Session 10

Expression systems in Eukaryotic cells

Session 11

  • Expression systems in Yeast, Bacteria, Insect cell lines, Gene screening.

Session 12

Biosafety guidelines and containment strategies.

Session 13

Bioreactor design: Body construction

Session 14

aeration and agitation, operation and applications

Session 15

Microbial Growth: measurement

Session 16

batch and continuous culture and its kinetics

Session 17

Downstream processing

Session 18

recovery and purification of products

Session 19

Strains improvement

Session 20

Fermentation economics

Session 21

Cell lines: Definition, development, maintenance and management

Session 22

established cell lines and their characteristic features.

Session 23

Transgenic animals- Creating transgenic animals

Session 24

Example of transgenic animals-Dolly, Insects, Primates, mice

Session 25

Somaclonal and gameto clonal variation: applications and limitations.

Session 26

Transgenic Plants: Herbicide eesistant, insect Resistant

Session 27

drought/stress resistant, delayed ripening, Ti Plasmid and T-DNA transfer.

Session 28

Gene therapy: potential approach to gene therapy

Session 29

Southern Blotting

Session 30

Northern Blotting

Session 31

Western Blotting

Session 32

Iso-electric Focusing

Session 33

Overview of Stem cells and its applications

Session 34

Introduction to industry important recombinant proteins, recombinant protein stability

Session 35

Improvised recombinant protein secretion

Session 36

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

Session 37

Microbial production: Antibiotics, acetic acid, lactic acid, wine, beer, SCP

Session 38

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

Session 39

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

Session 40

Introduction to pharmacopoeia

Session 41

Intellectual Property Rights

Session 42

Importance of protecting scientific discoveries

Session 43

IPR policy of Government of India

Session 44-

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

Case Studies

Case Studies

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