Doctor Seble Wagaw
Abbvie
Drug Substance
Control and Strategy
Development
Thursday
November 5th,
2015 11:00 am
Room 1315
Chemistry
The development of a control strategy for
a commercial drug substance
manufacturing process is built by
correlating the attributes of the drug that
are important to the patient to the
manufacturing conditions. Emphasis is
placed on developing a deep understanding
of the impact that reaction chemistry and
processing conditions has on the quality of
the product. Various approaches to
developing this understanding will be
described, with an emphasis on the use of
multivariate experimental approaches.