Biomedical Engineering Reference
In-Depth Information
12
BIOPHARMACEUTICAL
MANUFACTURING
RUHI AHMED AND THOMAS GENOVA
12.1 A GENERAL APPROACH TO IMPLEMENTING QRM
IN BIOPHARMACEUTICAL MANUFACTURING
Risks are associated throughout the biopharmaceutical manufacturing process,
from raw material supply through manufacturing and filling operations to final
distribution via a controlled cold chain process. Although many of these risks
apply equally to small molecules and biologics, assessing relevant attributes and
risks for biotechnology-derived products is more complicated—as stated by the
FDA “a much greater challenge for complex pharmaceuticals” [1]. Control often
is more challenging with biotechnology products because they are difficult to
characterize and the manufacturing processes are complex and variable. However,
the application of risk management practices enables manufacturers to design
processes that can proactively identify, mitigate, and/or control risks in a manner
which ensures high-quality biotechnology drug products to patients.
As noted in ICH Q9 “Quality Risk Management,” risk management is integral
to product development because it enables manufacturers to “design a qual-
ity product and its manufacturing process to consistently deliver the intended
performance of the product” [2]. For manufacturing process development, the
implementation of risk management can begin with the identification of the qual-
ity target product profile and an analysis of user requirements. Process knowledge
is gained through a comprehensive process development route, which carefully
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