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Impurities storage-related

Product-related substances are molecular variants of the desired product formed during manufacture and storage, which are active and have no deleterious effect on the safety and efficacy of the drug product.2 Many recombinant protein products are inherently heterogeneous, mixtures of closely related structures or product variants. These variants possess properties comparable to the desired product and are not considered impurities. It is only when they do not have properties of the desired product that their presence is problematic. [Pg.283]

Product-related impurities are molecular variants of the desired product (e.g., precursors, certain degradation products arising during manufacture and storage) which do not have properties comparable to those of the desired product with respect to activity, efficacy, and safety.2 Variants may exert different biological effects (potentially uncontrolled or hazardous) and specifically lead to antibody formation in the patient.3... [Pg.283]

Many early carbon capture and storage projects will not involve hydrogen, but rather will involve the capture of the C02 impurity in natural gas, the capture of C02 produced at electric plants, or the capture of C02 at ammonia and synfu-els plants. All of these routes to capture, however, share carbon storage as a common component, and carbon storage is the area in which the most difficult institutional issues and the challenges related to public acceptance arise. [Pg.22]


See other pages where Impurities storage-related is mentioned: [Pg.25]    [Pg.1000]    [Pg.3623]    [Pg.3624]    [Pg.87]    [Pg.251]    [Pg.2057]    [Pg.1]    [Pg.73]    [Pg.173]    [Pg.453]    [Pg.26]    [Pg.388]    [Pg.287]    [Pg.272]    [Pg.275]    [Pg.288]    [Pg.19]    [Pg.98]    [Pg.1]    [Pg.96]    [Pg.575]    [Pg.539]    [Pg.1]    [Pg.87]    [Pg.818]    [Pg.1678]    [Pg.1750]    [Pg.78]    [Pg.433]    [Pg.142]    [Pg.171]    [Pg.19]    [Pg.98]    [Pg.250]    [Pg.193]    [Pg.298]    [Pg.251]    [Pg.129]    [Pg.1815]    [Pg.358]    [Pg.394]    [Pg.687]    [Pg.344]    [Pg.476]    [Pg.87]   
See also in sourсe #XX -- [ Pg.13 ]




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