Forced degradation studies involve exposing a drug substance to
harsher conditions than the product would be expected to
experience and determining at what point and how it degrades.
Identifying strategies to minimize the effects of variable
temperature, humidity, and lighting conditions on the structural
integrity and biological activity of bioproducts during drug
development, manufacturing, storage, and administration is
another important aspect of this field of study. Stability
testing of biological drugs should be more comprehensive than
that of small molecule compounds, states Duu-Gong Wu, Ph.D.,
senior director, PharmaNet Consulting at PharmaNet (Washington,
D.C.). "It should cover many more aspects of drug development
and manufacturing," including holding time, shipping,
freeze/thaw cycles, temperature, exposure to oxygen and light,
physical stress, and excipient and container compatibility.
"Some characterization work should be done early in the
development of a drug to identify the degradation pathwa