Attachment IV - Page 24 
-2- DRAFT 
NOVEMBER 7, 1983 
Table of Coaceata 
I. Introduction 
II. General Considerations 
III* Expresslpn System 
IV. Master Cell Bank 
V. Production 
VI. Purification 
VII. Characterization of the Product 
A. Physicochemical Characterization 
B. Biological Tests 
C. Tests for Contaminants 
D. Toxicity Tests In Animals 
VIII. Modified Protein Products 
IX. Clinical Trials 
[51] 
