FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
News|Articles|May 15, 2014
- Pharmaceutical Technology-05-15-2014
- Volume 2014 eBook
- Issue 2
Determining Protein Oxidation Induced During Fill-Finish Operations
The effect of absorbed vapor-phase hydrogen peroxide on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide.
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Residual hydrogen peroxide (HP) from the vapor-phase HP (VPHP) isolator decontamination process can diffuse into drug product, potentially resulting in significant protein oxidation and thus impacting product quality. The effect of absorbed VPHP on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide and the stability of the lyophilized product was studied for up to six months.
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Using Modular Systems in Biopharmaceutical Manufacturingover 12 years ago
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