Write steps for manufacturing of bio-pharmaceuticals.
[3 marks]Write difference between generics and biosimilars.
[4 marks]Write a note on immunogenenicity and allergenicity of biosimilars.
[7 marks]What are developmental and regulatory challenges in biosimilar development.
[3 marks]Write a note on organ book.
[4 marks]Briefly describe biosimilar of hGH hormone.
[7 marks]Explain biosimilar drugs: Nucleic acid based therapies.
What is KLa in upstream optimization of recombinant protein biosimilar?
[3 marks]Write a note on types of bioequivalence.
[4 marks]Give brief note on Case study of KYMRIAH.
[7 marks]Write a note on cGMP requirements.
[3 marks]Give experimental designs for bio equivalence studies.
[4 marks]Write case study on any one biosimilar antibody used for treatment of cancer.
[7 marks]Expand the term ECP. Give 2 key aspects of ECP.
[3 marks]Write principle and working of affinity chromatography.
[4 marks]Describe process pipeline for searching for candidate biosimilar with patent search and nucleotide database.
[7 marks]Describe market value of biosimilars.
[3 marks]Write merits and demerits of size exclusion chromatography.
[4 marks]Write an note on humira biosimilar.
[7 marks]What are the steps for formulation of final biosimilar product? Page 1 of
[2 marks]Give process pipeline for selection of vector for recombinant protein biosimilar.
[4 marks]What are biosimilar insulins? Briefly describe.
[7 marks]Enlist prerequisites for development of biosimilars.
[3 marks]How will you evaluate genetic stability of cell line?
[4 marks]Briefly describe upstream optimization of recombinant protein biosimilar. Page 2 of
[2 marks]