"The greater our knowledge increases, the more our ignorance unfolds. "
U. S. President John F. Kennedy, speech, Rice University, September 12,
1962 My primary purpose for writing this book was much more than to
provide another information source on Chemistry, Manufacturing &
Controls (CMC) that would rapidly become out of date. My primary purpose
was to provide insight and practical suggestions into a common sense
business approach to manage the CMC regulatory compliance requirements
for biopharmaceuticals. Such a common sense business approach would need
(1) to be applicable for all types of biopharmaceutical products both
present and future, (2) to address the needs of a biopharmaceutical
manufacturer from the beginning to the end of the clinical development
stages and including post- market approval, and (3) to be adaptable to
the constantly changing CMC regulatory compliance requirements and
guidance. Trying to accomplish this task was a humbling experience for
this author! In Chapter 1, the CMC regulatory process is explained, the
breadth of products included under the umbrella ofbiopharmaceuticals are
identified, and the track record for the pharmaceutical and
biopharmaceutical industry in meeting CMC regulatory compliance is
discussed. In Chapter 2, while there are many CMC commonalities between
biopharmaceuticals and chemically-synthesized pharmaceuticals, the
significant differences in the way the regulatory agencies handle them
are examined and the reasons for why such differences are necessary is
discussed. Also, the importance of CMC FDA is stressed.
