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M.Pharm Pharmaceutical Biotechnology Syllabus

Pharmaceutical Biotechnology is the M.Pharm specialisation on microbial and cellular biology, bioprocess technology and biological products. This page gives the complete syllabus of the branch as prescribed by the Pharmacy Council of India, subject by subject and unit by unit.

Source: Pharmacy Council of India (PCI), The Revised Regulations for the Master of Pharmacy Degree Program, Credit Based Semester System, and the M.Pharm syllabus prescribed by the Pharmacy Council of India. The syllabus below is reproduced from the PCI syllabus, unit by unit.

Semester 1

MPB101T Modern Pharmaceutical Analytical Techniques

Unit 1: Spectroscopy I

Unit 2: NMR spectroscopy

Quantum numbers and their role in NMR, principle, instrumentation, solvent requirement in NMR, relaxation process, NMR signals in various compounds, chemical shift, factors influencing chemical shift, spin-spin coupling, coupling constant, nuclear magnetic double resonance, brief outline of principles of FT-NMR and 13C NMR, applications of NMR spectroscopy.

Unit 3: Mass spectroscopy

Principle, theory, instrumentation of mass spectroscopy, different types of ionization like electron impact, chemical, field, FAB and MALDI, APCI, ESI, APPI, analyzers of quadrupole and time of flight, mass fragmentation and its rules, metastable ions, isotopic peaks, applications of mass spectroscopy.

Unit 4: Chromatography

Principle, apparatus, instrumentation, chromatographic parameters, factors affecting resolution, isolation of drug from excipients, data interpretation and applications of: thin layer chromatography, high performance thin layer chromatography, ion exchange chromatography, column chromatography, gas chromatography, high performance liquid chromatography, ultra high performance liquid chromatography, affinity chromatography, gel chromatography.

Unit 5: Electrophoresis and X-ray crystallography

Electrophoresis: principle, instrumentation, working conditions, factors affecting separation and applications of paper electrophoresis, gel electrophoresis, capillary electrophoresis, zone electrophoresis, moving boundary electrophoresis, isoelectric focusing. X-ray crystallography: production of X rays, different X ray diffraction methods, Bragg law, rotating crystal technique, X ray powder technique, types of crystals, applications of X ray diffraction.

Unit 6: Potentiometry and thermal techniques

Potentiometry: principle, working, ion selective electrodes, applications. Thermal techniques: principle, thermal transitions and instrumentation (heat flux and power compensation designs), modulated DSC, hyper DSC, experimental parameters (sample preparation, experimental conditions, calibration, heating and cooling rates, resolution, source of errors) and their influence, advantages and disadvantages, pharmaceutical applications. Differential thermal analysis (DTA): principle, instrumentation, advantages and disadvantages, pharmaceutical applications, derivative differential thermal analysis (DDTA). TGA: principle, instrumentation, factors affecting results, advantages and disadvantages, pharmaceutical applications.

MPB102T Microbial and Cellular Biology

Unit 1: Microbiology

Microbiology: Introduction, Prokaryotes and Eukaryotes. Bacteria, fungi, actinomycetes and virus, structure, chemistry and morphology, cultural, physiological and reproductive features. Methods of isolation, cultivation and maintenance of pure cultures. Industrially important microorganisms, examples and applications.

Unit 2: Molecular Biology

Molecular Biology: Structure of nucleus and chromosome, Nucleic acids and composition, structure and types of DNA and RNA. Central dogma of molecular biology: Replication, Transcription and translation. Gene regulation: Gene copy number, transcriptional control and translational control. RNA processing: Modification and Maturation, RNA splicing, RNA editing, RNA amplification. Mutagenesis and repair mechanisms, types of mutants, application of mutagenesis in strain improvement, gene mapping of plasmids, types purification and application. Phage genetics, genetic organization, phage mutation and lysogeny.

Unit 3: Cell structure and function

Cell structure and function: Cell organelles, cytoskeleton & cell movements, basic aspects of cell regulation, bioenergetics and fuelling reactions of aerobics and anaerobics, secondary metabolism & its applications. Cell communication, cell cycle and apoptosis, mechanism of cell division. Cell junctions/adhesion and extra cellular matrix, germ cells and fertilization, histology, the life and death of cells in tissues. Cell Cycle and Cytoskeleton: Cell Division and its Regulation, G-Protein Coupled Receptors, Kinases, Nuclear receptors, Cytoskeleton & cell movements, Intermediate Filaments. Apoptosis and Oncogenes: Programmed Cell Death, Tumor cells, carcinogens & repair. Differentiation and Developmental Biology: Fertilization, Events of Fertilization, In vitro Fertilization, Embryonic Germ Cells, Stem Cells and its Application.

Unit 4: Principles of microbial nutrition

Principles of microbial nutrition: Physical and chemical environment for microbial growth, Stability and degeneration of microbial cultures. Growth of animal cells in culture: General procedure for cell culture, Nutrient composition, Primary, established and transformed cell cultures, applications of cell cultures in pharmaceutical industry and research. Growth of viruses in cell culture propagation and enumeration. In-vitro screening techniques, cytotoxicity, anti-tumor, anti-viral assays.

Unit 5: Microbial pathology

Microbial pathology: Identifying the features of pathogenic bacteria, fungi and viruses. Mechanism of microbial pathogenicity, etiology and pathology of common microbial diseases and currently recommended therapies for common bacterial, fungal & viral infections. Mechanism of action of antimicrobial agents and possible sites of chemotherapy.

MPB103T Bioprocess Engineering and Technology

Unit 1: Introduction to fermentation technology

Introduction to fermentation technology: Basic principles of fermentation. Study of the design and operation of bioreactor. Ancillary parts and function, impeller design and agitation, power requirements on measurements and control of dissolved oxygen, carbon dioxide, temperature, pH and foam. Types of bioreactor: CSTR, tower, airlift, bubble column, packed glass bead, hollow fiber, configuration and application. Computer control of fermentation process: System configuration and application.

Unit 2: Mass transfer

Mass transfer: Theory, diffusional resistance to oxygen requirements of microorganisms, measurements of mass transfer coefficient and factor affecting them, effects of aeration and agitation on mass transfer, supply of air, air compressing, cleaning and sterilization of air and plenum ventilation, air sampling and testing standards for air purity. Rheology: Rheological properties of fermentation system and their importance in bioprocessing.

Unit 3: Scale up of fermentation process

Scale up of fermentation process: Principles, theoretical considerations, techniques used, media for fermentation, HTST sterilization, advantage and disadvantage, liquid sterilization. Cultivation and immobilized culture system: Cultivation system, batch culture, continuous culture, synchronous cultures, fed batch culture. Graphical plot representing the above systems. Introduction to immobilization Techniques, immobilization of whole cell, immobilized culture system to prepare fine chemicals. Immobilization of enzymes and their applications in the industry. Reactors for immobilized systems and perspective of enzyme engineering.

Unit 4: Scale down of fermentation process

Scale down of fermentation process: Theory, equipment design and operation, methods of filtration, solvent extraction, chromatographic separation, crystallization, turbidity analysis and cell yield determination, metabolic response assay, enzymatic assay, bioautographic techniques and disruption of cells for product recovery. Isolation and screening: Primary and secondary, maintenance of stock culture, strain improvement for increased yield.

Unit 5: Bioprocessing of the industrially important microbial metabolites

Bioprocessing of the industrially important microbial metabolites: a) Organic solvents, Alcohol and Glycerol, b) Organic acids, Citric acids, Lactic acids, c) Amino acids, Glutamic acids, Lysine, Cyclic AMP and GMP, d) Antibiotics, Penicillin, Streptomycin, Griseofulvin, e) Vitamins, B12, Riboflavin and Vitamin C. Biosynthetic pathways for some secondary metabolites, microbial transformation of steroids and alkaloid. Regulation governing the manufacturing of biological products.

MPB104T Advanced Pharmaceutical Biotechnology

Unit 1: Enzyme Technology

Enzyme Technology: Classification, general properties of enzymes, dynamics of enzymatic activity, sources of enzymes, extraction and purification, pharmaceutical, therapeutic and clinical application. Production of amyloglucosidase, glucose isomerase, amylase and trypsin.

Unit 2: Genetic Engineering

Genetic Engineering: Techniques of gene manipulation, cloning strategies, procedures, cloning vectors expression vectors, recombinant selection and screening, expression in E. coli and yeast. Site directed mutagenesis, polymerase chain reaction, and analysis of DNA sequences. Gene library and cDNA. Applications of the above technique in the production of, Regulatory proteins, Interferon, Interleukins, Blood products, Erythropoietin, Vaccines, Hepatitis-B, Hormones, Insulin.

Unit 3: Therapeutic peptides

Therapeutic peptides: Study on controlled and site specified delivery of therapeutic peptides and proteins through various routes of administration. Transgenic animals: Production of useful proteins in transgenic animals and gene therapy. Human Genome: The human genome project, a brief study, Human chromosome, Structure and classification, chromosomal abnormalities, Syndromes.

Unit 4: Signal transduction

Signal transduction: Introduction, cell signaling pathways, Ion channels, Sensors and effectors, ON and OFF mechanisms, Spatial and temporal aspects of signaling, cellular process, development, cell cycle and proliferation, neuronal signaling, cell stress, inflammatory responses and cell death, signaling defects and diseases. Oncogenes: Introduction, definition, various oncogenes and their proteins.

Unit 5: Microbial Biotransformation

Microbial Biotransformation: Biotransformation for the synthesis of chiral drugs and steroids. Microbial Biodegradation: Biodegradation of xenobiotics, chemical and industrial wastes, Production of single-cell protein, Applications of microbes in environmental monitoring. Biosensors: Definition, characteristics of ideal biosensors, types of biosensors, biological recognition elements, transducers, application of biosensors.

Practicals and Seminar

Semester 2

MPB201T Proteins and Protein Formulation

Unit 1: Protein engineering

Protein engineering: Concepts for protein engineering. Isolation and purification of proteins, Stability and activity based approaches of protein engineering, Chemical and Physical Considerations in Protein and Peptide Stability, Different methods for protein engineering, gene shuffling, and direct evolution.

Unit 2: Peptidomimetics

Peptidomimetics: Introduction, classification; Conformationally restricted peptides, design, pseudopeptides, peptidomimetics and transition state analogs; Biologically active template; Amino acid replacements; Peptidomimetics and rational drug design; CADD techniques in peptidomimetics; Development of non peptide peptidomimetics.

Unit 3: Proteomics

Proteomics: Protein identification and characterization: Methods/strategies, protein identification, de novo protein characterization, Isotope labelling, N and C terminal tags. 2-Dimensional gel electrophoresis Methods including immobilized pH gradients (IPGs), resolution, reproducibility and image analysis, future developments.

Unit 4: Protein formulation

Protein formulation: Different strategies used in the formulation of DNA and proteins, Analytical and biophysical parameters of proteins and DNA in preformulation, Liposomes, Neon-spears, Neon-particulate system, PEGylation, Biological Activity, Biophysical Characterization Techniques, Forced degradation studies of protein.

Unit 5: Methods of protein sequencing

Methods of protein sequencing: Various methods of protein sequencing, characterisation, Edman degradation, Tryptic and/or Chymotryptic Peptide Mapping.

MPB202T Immunotechnology

Unit 1: Fundamental aspects of immunology

Fundamental aspects of immunology: Introduction, cells and organs of the immune system, cellular basis of Immune response, primary and secondary lymphoid organs, antigen antibody and their structure. Types of immune responses, anatomy of immune response. Overview of innate and adaptive Immunity. Humoral Immunity: B-Lymphocytes and their activation. Structure and function of immunoglobulins, idiotypes and anti idiotypic antibodies. Cell mediated Immunity: Thymus derived lymphocytes (T cells), their ontogeny and types, MHC complex, antigen presenting cells (APC), mechanisms of T cell activation, macrophages, dendritic cells, langerhans cells, mechanism of phagocytosis.

Unit 2: Immune Regulation and Tolerance

Immune Regulation and Tolerance: Complement activation and types and their biological functions, cytokines and their role in immune response. Hypersensitivity: Hypersensitivity Types I-IV, Hypersensitivity reactions and treatment. Autoimmune diseases.

Unit 3: Vaccine technology

Vaccine technology: Vaccine and their types, conventional vaccines, novel methods for vaccine production, antiidiotype vaccine, DNA vaccine, genetically engineered vaccine, iscoms, synthetic peptides, and immunodiagnostics. Stem cell technology: Stem cell technology and applications to immunology.

Unit 4: Hybridoma Technology

Hybridoma Technology: Hybridoma techniques, fusion methods for myeloma cells and B Lymphocytes, selection and screening techniques. Production and purification of monoclonal antibodies and their applications in Pharmaceutical industry.

Unit 5: Immunological Disorder

Immunological Disorder: Autoimmune disorders and types, pathogenic mechanisms, treatment, experimental models of auto immune diseases, primary and secondary immunodeficiency disorders. Immunodiagnosis: Antigen antibody interaction, Precipitation reaction, Agglutination reactions, Principles and applications of ELISA, Radio Immuno Assay, Western blot analysis, immune-electrophoresis, immuno fluorescence, chemiluminescence assay, complement fixation reaction.

MPB203T Bioinformatics and Computer Technology

Unit 1: Introduction to Bioinformatics

Introduction to Bioinformatics: Definition and History of Bioinformatics, Internet and Bioinformatics, Introduction to Data Mining, Applications of Data Mining to Bioinformatics, Biological Database: Protein and nucleic acid databases. Structural data bases. Collecting and storing the sequence and Applications of Bioinformatics.

Unit 2: Sequence analysis

Sequence analysis: Sequence alignment, pair wise alignment techniques, multiple sequence analysis, multiple sequence alignment; Flexible sequence similarity searching with the FAST3 program package, the use of CLUSTAL W and CLUSTAL X for the multiple sequence alignment. Tools used for sequence analysis.

Unit 3: Protein informatics

Protein informatics: Introduction; Force field methods; Energy, buried and exposed residues, side chains and neighbours; Fixed regions, hydrogen bonds, mapping properties onto surfaces; Fitting monomers, R & S fit of conformers, assigning secondary structures; Sequence alignment, methods, evaluation, scoring; Protein completion, backbone construction and side chain addition; Small peptide methodology, software accessibility, building peptides; Protein displays; Substructure manipulations, annealing. Protein structure prediction: Protein folding and model generation; Secondary structure prediction, analyzing secondary structures; Protein loop searching, loop generating methods, loop analysis; Homology modeling, concepts of homology modeling, potential applications, description, methodology, homologous sequence identification; Align structures, align model sequence; Construction of variable and conserved regions, threading techniques, Topology fingerprint approach for prediction, evaluation of alternate models; Structure prediction on a mystery sequence, structure aided sequence techniques of structure prediction, structural profiles, alignment algorithms, mutation tables, prediction, validation, sequence based methods of structure prediction, prediction using inverse folding, fold prediction; Significance analysis, scoring techniques, sequence-sequence scoring. Docking: Docking problems, methods for protein-ligand docking, validation studies and applications; Screening small molecule databases, docking of combinatorial libraries, input data, analyzing docking results.

Unit 4: Diversity of Genomes

Diversity of Genomes: Prokaryotic and Eukaryotic Gene Families. Genome Analysis: Introduction, Gene prediction methods, Gene mapping and applications, Genetic and Physical Mapping, Integrated map, Sequence assembly and gene expression. Completed Genomes: Bacterium, Nematode, Plant and Human. Evolution of Genomes: Lateral or Horizontal Transfer among Genomes, Transcriptome and Proteome, General Account. Phylogenetic analysis: Evolutionary Change in Nucleotide Sequences, Rates and Patterns of Nucleotide Substitution, Models for Nucleotide Substitution, Construction of Phylogenetic Tree, Genome Annotation technique.

Unit 5: Target searching and Drug Designing

Target searching and Drug Designing: Target and lead, timeline for drug development, target discovery, target modulators, In-silico gene expression, microarray, and lead discovery, libraries of ligands, active site analysis, and prediction of drug quality.

MPB204T Biological Evaluation of Drug Therapy

Unit 1: Biological Standardization

Biological Standardization: General principles, Scope and limitation of bio-assay, bioassay of some official drugs. Preclinical drug evaluation: Preclinical drug evaluation of its biological activity, potency and toxicity. Toxicity test in animals including acute, sub-acute and chronic toxicity, ED50 and LD50 determination, special toxicity test like teratogenicity and mutagenicity. Guidelines for toxicity studies: Various guidelines for toxicity studies. Animal experiments assessing safety of packaging materials.

Unit 2: Pyrogens

Pyrogens: Sources, Chemistry and properties of bacterial pyrogens and endotoxins, Official pyrogen tests. Microbiological assay: Assay of antibiotics and vitamins. Biological evaluation of drugs: Screening and evaluation (including principles of screening, development of models for diseases: In vivo models / In vitro models / cell line study).

Unit 3: Biologic Medicines in Development for various diseases

Biologic Medicines in Development for various diseases, By Therapeutic Category: Genetic Disorders, Eye related Disorders, Digestive Disorders, Diabetes/Related Conditions, Cardiovascular Disease, Cancer/Related Conditions, Blood Disorders, Autoimmune Disorders, Infectious Diseases, Neurologic Disorders, Skin Diseases, Organ Transplantation. Biologic Medicines in Development for various diseases, by Product Category: Antisense, Vaccines, Recombinant Hormones/Proteins, Monoclonal Antibodies (mAb), Interferons, Growth Factors, Gene Therapy, RNA Interference.

Unit 4: Regulatory aspects: drugs, biologics and medical devices

Regulatory aspects: drugs, biologics and medical devices: An introduction to the regulations and documents necessary for approval of a medical product. Regulatory consideration: Regulatory consideration for pre-clinical testing and clinical testing of drugs, biologics and medical devices. New Drug Applications for Global Pharmaceutical Product Approvals.

Unit 5: Bioavailability

Bioavailability: Objectives and consideration in bio-availability studies of Biopharmaceuticals, Concept of equivalents, Measurements of bio-availability. Determination of the rate of absorption, Bioequivalence and its importance, Regulatory aspects of bio-availability and bioequivalence studies for conventional dosage forms and controlled drug delivery systems of Biopharmaceuticals. Pharmacokinetics: Basic consideration, Pharmacokinetic models, Application of Pharmacokinetics in new drug development of Biopharmaceuticals and designing of dosage forms and Novel drug delivery systems of Biopharmaceuticals.

Practicals and Seminar

Semester 3 and 4

Semester 3 and Semester 4 are common to all M.Pharm specialisations: Research Methodology and Biostatistics (MRM301T), Journal Club, Discussion / Presentation and Research Work. See the M.Pharm common syllabus page for the full common syllabus.