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Article: Only Time Will Tell With Biotech QbD
By James Netterwald, Ph.D.
When manufacturing a pharmaceutical product, there are various attributes that contribute to overall quality, including solubility, toxicity, and uniformity. These attributes are affected by process parameters, such as temperature inside of a bioreactor or gas chamber, internal pressure of a bioreactor, concentration of catalysts or raw materials, and diffusion rates. These variables are what are commonly referred in the QbD (quality by design) concept as attributes. The combination of, and interaction between, all of these attributes is referred to as the design space.
Used with permission from Life Science Leader magazine.
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