1993 Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals

Regulatory Resource: 1993 Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals

Description:

This document supersedes the “Points to Consider (PTC) in the
Characterization of Cell Lines Used to Produce Biologicals (1987)” and
reflects a number of changes emanating from;% several international
workshops held since that time .(1,2).- As stated in the 1987 PTC, the
current approach to working with cell lines to produce biological products
focuses on:
1. production, identification and characterization of the cell substrate;
2. validation of the manufacturing process for removal and/or inactivation of adventitious agents;
3.testing of the bulk and final product to assure safety.

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