Compare generics, biologics and biosimilars.
[3 marks]Explain the different stages for development of Biosimilars.
[4 marks]compare various cell lines used in biosimilar development.
[7 marks]What is transient transfection?
[3 marks]Write down the selection of key differences in EU and in Us.
[4 marks]Explain the difference between a generic drug and a biosimilar drug, and justify the need for a short pathway for introduction of a biosimilar drug into the market.
[7 marks]Explain any two Biosimilar drugs in brief.
[7 marks]Explain challenges in development and regulation of Biosimilar drugs.
[3 marks]Write a note on formulation of biosimilar drug.
[4 marks]Enlist various factors affecting immunogenicity of biosimilar drug and explain any one in detail.
[7 marks]Explain allergenicity in bioequivalence studies.
[3 marks]Compare orange book and purple book.
[4 marks]Explain briefly about types of Bioequivalence studies.
[7 marks]Define bioequivalence in details.
[3 marks]Explain the terms switching and interchangibility.
[4 marks]Explain in details about Cell based biosimilars.
[7 marks]Give advantages of KYMRIAH.
[3 marks]Write a note on Erythroprotein.
[4 marks]Discuss Hydrophobic interaction chromatography in detail.
[7 marks]What are expression vectors?
[3 marks]What is codon optimization? What is its role in biosimilars development?
[4 marks]Explain in details about CAR-Tcells1
[7 marks]Discuss genetic stability of cell line.
[3 marks]Discuss use of kozak sequence in biosimilars development.
[4 marks]Discuss Ion exchange chromatography in detail.
[7 marks]