MSc Biotechnology SEM III BIOTECHNOLOGY BIOLOGICS AND REGULATORY AFFAIRS Question Paper - Mumbai University | munotes

Questions asked in this paper

• 3) Figures to the right indicate full marks

1. Q4 All questions carry equal marks Answer the following (Any Two): 12
   • a) | What do you mean by Small molecules as biologics and biosimilars? Discuss any 2 distinguishing points between large molecules and small molecules
   • b) | What do you mean by Biogenerics? Give any 2 examples of USFDA approved biogenerics and state its use in therapeutics
   • c) Discuss Enzymes as Biologics. Give 2 examples of the USFDA approved Enzymes used in therapeutics and diagnostics
   • d) on the role DCGI in the regulatory process of Biosimilars in India
2. Q2 Attempt the following (Any two): 12 marks
   • a) cell line? Explain the stability of the cell lines
   • b) What is scale up manufacturing? Explain with some tips to help scale up
   • c) Explain the steps in the production of monoclonal antibodies
   • d) the concept of biosimilars with examples Give an account of the following (Any two): 12
   • a) | How Mass spectra and Fluorescence spectra can be helpful in biosimilar
   • b) Give details of any 3 proteolytic enzymes which are used while characterization of
   • c) Elaborate on Isoelectric Focusing (IEF) method used for analysis of post translation modifications in biosimilar products
   • d) How size and purity of biosimilar product can be analysed by PAGE? Answer the following (Any two): 12
   • a) Explain in detail — Regulation of biosimilars
   • b) Discuss India-biosimilar regulatory requirements in detail
   • c) in detail — Biological product
   • d) Elaborate on — Abbreviated licensure pathway
3. Q5 Write short notes on (Any Three): 12 marks
   • a) Vaccines as Biologics
   • b) Manufacturing conditions
   • c) Virus filtration
   • d) blotting for biosimilar analysis
   • f) trials initiation and filling of biosimilar application

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