Description

A .List and explain the key steps in an  Action Plan for Process Evaluation of Viral Clearance and Virus Tests on biotherapeutic products.

                                                                                                         50 marks

B .Calculate the Estimated Viral Particles (endogenous retroviruses. ) per Dose given the following data:

 Measured or estimated concentration of virus in cell culture harvest = 107 /ml

 Calculated Virus Clearance Factor = >10 15

 Volume of Culture harvest needed to make a dose of product = 1 litre (10 3ml)

Return date 9th Jan 2020