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