ABSTRACT
Cell culture processes involving mammalian cells present
certain unique challenges from a validation perspective.
Fundamentally, the objective of any cell culture validation
program is to demonstrate that the cells and process are
suitable for their intended purpose and can consistently
operate within the manufacturing setting in such a
manner that a consistent product will result. In this
chapter, the focus will be on mammalian cells used to
produce biopharmaceuticals such as recombinant
proteins and monoclonal antibodies. Particular emphasis
is given to the unique challenges and issues associated
with mammalian cell-based production. Case studies and
examples are provided to illustrate how key validation
principles and guidelines have been interpreted and
applied in support of actual manufacturing processes.
Because the experience of the authors has relied heavily
on the use of CHO cells, the examples are drawn
substantially from this platform but are representative
of the issues, thinking, and approaches that must be
applied to any mammalian cell culture process.
