ABSTRACT
No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster
TABLE OF CONTENTS
part |1 pages
Part I - Regulatory and Manufacturing
part 7|2 pages
Analysis of the Expression Construct in Cells Used for Production of rDNA-Derived Protein Products