PHARMACEUTICAL BIOTECHNOLOGY Question Papers 4 A.U

Answer question no.1(compulsory) and any four of the remaining. All questions carry equal marks

1. With the help of a neat diagram explain the different parts of a fermenter and mention this functions. Add notes on the different types of fermenters used.

2. Describe in detail the fermentative production, recovery and applications of citric acid.

3. Discuss about different methods for immobilization of enzymes. Write about the advantages and disadvantages of immobilization.

4. Explain the production of Interferons by r-DNA technology.

5. Define enzymes and discuss this properties. Explain general methods of their preparation and applications in pharmacy, therapeutics and clinical analysis.

6. Write notes on:

• Mutagens and their mechanism of action.
• Transformation with recombinant plasmid DNA
• DNA Probes for diagnosis of genetic diseases
• Southern blotting and Northern blotting.

7. Write short notes on:

• Explain the process of protoplast fusion and its applications.
• Methods of cutting and joining of DNA molecules.

8. What is plasmid vector. Write about the properties of plasmids and desirable characteristics of a cloning vector. Discuss about natural and artificail plasmids.

PHARMACEUTICAL BIOTECHNOLOGY

Unit:-I: Biological Products
1. Animal Products:

• Insulin - Extraction, Purification and types of formulations
• Preparation and uses of pancreatin, pepsin, Heparin, Thyroid and Liver preparations as per I.P.

2. Blood products & Plasma substitutes: Preparation, uses and storage of the following; Whole human blood, Dried human plasma, human gamma globulins, clinical dextran and adsorbable haemostats.
3. Immunological products: Preparation & standardization of the following;

• Vaccines - BCG, DPT, Poliomyelitis and Typhus.
• Toxoids - Diptheria and Tetanus.
• Antitoxins - diptheria and Gas-gangrene

Unit-II: Fermentation Products
Introduction to fermentation, aerobic and anaerobic, surface, submerged and solid state state fermentation's and fermentation media. Design and operation of industrial fermenter. Fermentative production, recovery and uses of the following,

• Antibiotics - Penicillin and streptomycin
• Organic acids - Citric acid and Lactic acid
• Solvents - Alcohol
• Vitamins - Vitamin B12
• Miscellaneous - Lactobacillus spores

Unit-III: Testing methods
1. test for sterility: Strility testing media, sampling, neutralization of various antimicrobial substances in dosage froms, conducting the tests for injections, surgical sutures (Catgut), cotton, tubing's and bottles.
2. Principles of microbiological assay of amino acids, vitamins and antibiotics. Detailed assay of Lysine, vitamin B12 and penicillin.
3. radio-immuno assay (RIA): Principle and applications. Estimation of insulin in blood by RIA. ELISA: principle and applications

Unit-IV: Enzymes, Enzyme immobilization and microbial transformations
1. Enzymes: Sources and general methods of preparation. Preparation of Fungal diastate. Applications in pharmaceutical industry, therapeutics and clinical assays
2. Immobilization: Advantages and limitations, techniques of immobilization of enzymes and cells.
3. Microbial transformations: Advantages, different types of microbial and steroid conversions.

Unit-V: Recombinant DNA technology
1. Introduction to genetic engineering. Brief description of a) Restriction of DNA b) Ligation of DNA c) Introduction into host cells d) Recombinant selection e) Use of the plasmids and bacteriophages as cloning vehicles, artificial plasmid vectors, cosmids and phasmids f) Agarose gel electrophoresis, southern, northern and western blotting.
2. Applications of rDNA technology: Production of Human insulin and Hepatitis B vaccine. Hybridoma technology: Production of monoclonal antibodies and their applications.
3. Bioinformatics: Introduction, scope and applications