ABSTRACT
This chapter addresses validation of process chromatog-
raphy-one of the tools that provide today’s highly pure
biopharmaceuticals. Process chromatography is also used
to purify, and thus enhance the safety of, traditional
biologicals such as plasma-derived products and
vaccines. For biopharmaceuticals, multiple chromato-
graphic steps are employed to remove host cell DNA,
HCP, viruses, modified product, and processing impu-
rities. Together with unit operations such as
centrifugation and filtration, chromatography steps are
an integral part of downstream processing, taking a
product from a crude feedstock to a purified form
suitable for use as a biopharmaceutical, vaccine or
health care agent. Each chromatographic step can
usually remove multiple impurities. Understanding the
purity goals of each chromatographic step expedites the
validation process.
